Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT)

• Sponsor: Aclaris Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03315689
• Collaborator: (none)
• Enrollment: 11
• Locations: 2
• Arms: 2
• Actual Duration (Months): 18.2
• Patients Per Site: 5.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The primary objective is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution compared to vehicle in subjects with AU and AT.

Condition or Disease	Intervention/Treatment	Phase
Alopecia Universalis (AU); Alopecia Totalis (AT)	Drug: Vehicle; Drug: ATI-50002	Phase 2

Detailed Description

This study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution in patients with Alopecia Universalis and Alopecia Totalis. Concentrations of ATI-50002 in the blood and skin will be assessed after 28 days of treatment with ATI-50002 Topical Solution.

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Vehicle-controlled Multicenter Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ATI-50002 Topical Solution Administered Twice-Daily for 28 Days in Adult Subjects With Alopecia Universalis and Alopecia Totalis With a 12-Month Long-Term Open-Label Extension
• Actual Study Start Date: Dec 14, 2017
• Actual Primary Completion Date: Jun 20, 2019
• Actual Study Completion Date: Jun 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Vehicle Vehicle	Drug: Vehicle; Vehicle Topical Solution
Experimental: Active ATI-50002 Topical Solution	Drug: ATI-50002; ATI-50002 Topical Solution

Outcome Measures

Primary Outcome Measures

1. Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29 [Day 2 - Day 29]

   ATI-50002 levels in scalp biopsies taken at Visits 3 (Day 2) and 7 (Day 29).

Secondary Outcome Measures

1. Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 52 [Baseline - Week 52]

   The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth.

2. Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 40 [Baseline - Week 40]

   The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth.

3. Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 28 [Baseline - Week 28]

   The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth.

4. Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 28 [Baseline - Week 28]

   The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.

5. Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 40 [Baseline - Week 40]

   The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.

6. Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 52 [Baseline - Week 52]

   The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.

7. Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 28 [Week 4 - Week 28]

   The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).

8. Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 40 [Week 4 - Week 40]

   The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).

9. Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 52 [Week 4 - Week 52]

   The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).

10. Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 28 [Week 4 - Week 28]

    The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).

11. Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 40 [Week 4 - Week 40]

    The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).

12. Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 52 [Week 4 - Week 52]

    The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).

13. Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 28 [Week 28]

    The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata.

14. Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 40 [Week 40]

    The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata.

15. Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 52 [Week 52]

    The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata.

16. Open Label Extension: Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 24 From Baseline [Baseline - Week 24]

    The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome).

17. Open Label Extension: Severity of Alopecia Tool (SALT Scores), Relative Percent Regrowth (%) at Week 40 From Baseline [Baseline - Week 40]

    The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome).

18. Open Label Extension: The Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 52 From Baseline [Baseline - Week 52]

    The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome).

19. Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 24 Weeks [Baseline - Week 24]

    The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome).

20. Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 40 Weeks [Baseline - Week 40]

    The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome).

21. Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 52 Weeks [Baseline - Week 52]

    The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Able to comprehend and willing to sign an Informed Consent Form (ICF).

• Male or non-pregnant, non-nursing female ≥18 years old at the time of informed consent.

• Have a clinical diagnosis of stable, clinically typical, AU or AT.

• Have a duration of the current episode of AU or AT for a minimum of 6 months and a maximum of seven years.

• Be willing and able to follow all study instructions and to attend all study visits.

Exclusion Criteria:

• Females who are nursing, pregnant, or planning to become pregnant for the duration of the study including 30 days after the last application of study medication.

• Patchy alopecia areata, diffuse alopecia areata or a history of an atypical pattern of Alopecia Areata (AA) (e.g., ophiasis, sisaihpo).

• Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments of efficacy or safety.

• Active scalp trauma or other condition affecting the scalp that, in the investigator's opinion, may affect the course of AU or AT or interfere with the study conduct or evaluations.

• The presence of a permanent or difficult to remove hairpiece or wig that will, in the opinion of the investigator, interfere with study assessments if not removed at each visit.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aclaris Investigational Site	New York	New York	United States	10032
2	Aclaris Investigational Site	New York	New York	United States	10075

Sponsors and Collaborators

• Aclaris Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Aug 14, 2018
• Statistical Analysis Plan - Dec 12, 2018

More Information

Publications

None provided.

• Responsible Party: Aclaris Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03315689
• Other Study ID Numbers: ATI-50002-AA-202
• First Posted: Oct 20, 2017
• Last Update Posted: Jul 2, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alopecia; Alopecia Areata

Study Results

Participant Flow

Arm/Group Title	Vehicle Topical Solution	ATI-50002 0.46% Topical Solution
Arm/Group Description	Vehicle Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution applied twice daily.
Period Title: Double-blind Period = 28 Days
STARTED	4	7
COMPLETED	3	7
NOT COMPLETED	1	0
Period Title: Double-blind Period = 28 Days
STARTED	0	10
COMPLETED	0	7
NOT COMPLETED	0	3

Baseline Characteristics

Arm/Group Title	Vehicle Topical Solution	ATI-50002 0.46% Topical Solution	Total
Arm/Group Description	Vehicle Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution applied twice daily.	Total of all reporting groups
Overall Participants	4	7	11
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 75%	5 71.4%	8 72.7%
>=65 years	1 25%	2 28.6%	3 27.3%
Sex: Female, Male (Count of Participants)
Female	3 75%	7 100%	10 90.9%
Male	1 25%	0 0%	1 9.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 25%	0 0%	1 9.1%
Not Hispanic or Latino	2 50%	4 57.1%	6 54.5%
Unknown or Not Reported	1 25%	3 42.9%	4 36.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 25%	3 42.9%	4 36.4%
White	3 75%	4 57.1%	7 63.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	4 100%	7 100%	11 100%
Fitzpatrick Skin Type (Count of Participants)
I - Always Burns	0 0%	2 28.6%	2 18.2%
II - Burns Easily	3 75%	2 28.6%	5 45.5%
III - Burns Moderately	0 0%	0 0%	0 0%
IV - Burns Minimally	0 0%	1 14.3%	1 9.1%
V - Rarely Burns	1 25%	2 28.6%	3 27.3%
VI - Never Burns	0 0%	0 0%	0 0%
Current Clinical Type of Alopecia (Count of Participants)
Totalis	1 25%	3 42.9%	4 36.4%
Universalis	3 75%	4 57.1%	7 63.6%
Time Since Onset of Current Episode of AU or AT (Weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Weeks]	145.8 (128.58)	218.3 (122.10)	191.9 (123.47)

Outcome Measures

1. Primary Outcome

Title	Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29
Description	ATI-50002 levels in scalp biopsies taken at Visits 3 (Day 2) and 7 (Day 29).
Time Frame	Day 2 - Day 29

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	Vehicle	Active
Arm/Group Description	Vehicle Vehicle: Vehicle Topical Solution	ATI-50002 Topical Solution ATI-50002: ATI-50002 Topical Solution
Measure Participants	3	6
V3 - Day 2	166.0 (83.44)	579.7 (322.36)
V7 - Day 29	NA (NA)	5710.0 (3647.87)

2. Secondary Outcome

Title	Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 52
Description	The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth.
Time Frame	Baseline - Week 52

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	4
Mean (Standard Deviation) [score on a scale]	-15.0 (16.21)

3. Secondary Outcome

Title	Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 40
Description	The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth.
Time Frame	Baseline - Week 40

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	4
Mean (Standard Deviation) [score on a scale]	-8.8 (12.84)

4. Secondary Outcome

Title	Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 28
Description	The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth.
Time Frame	Baseline - Week 28

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	8
Mean (Standard Deviation) [score on a scale]	-6.1 (11.91)

5. Secondary Outcome

Title	Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 28
Description	The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.
Time Frame	Baseline - Week 28

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	8
Mean (Standard Deviation) [score on a scale]	-7.1 (12.71)

6. Secondary Outcome

Title	Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 40
Description	The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.
Time Frame	Baseline - Week 40

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	4
Mean (Standard Deviation) [score on a scale]	-9.5 (10.66)

7. Secondary Outcome

Title	Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 52
Description	The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.
Time Frame	Baseline - Week 52

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	4
Mean (Standard Deviation) [score on a scale]	-12.0 (11.58)

8. Secondary Outcome

Title	Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 28
Description	The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).
Time Frame	Week 4 - Week 28

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	8
Mean (Standard Deviation) [score on a scale]	0.4 (0.90)

9. Secondary Outcome

Title	Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 40
Description	The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).
Time Frame	Week 4 - Week 40

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	4
Mean (Standard Deviation) [score on a scale]	0.5 (1.58)

10. Secondary Outcome

Title	Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 52
Description	The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).
Time Frame	Week 4 - Week 52

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	4
Mean (Standard Deviation) [score on a scale]	0.6 (1.38)

11. Secondary Outcome

Title	Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 28
Description	The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).
Time Frame	Week 4 - Week 28

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	8
Mean (Standard Deviation) [score on a scale]	0.1 (1.16)

12. Secondary Outcome

Title	Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 40
Description	The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).
Time Frame	Week 4 - Week 40

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	4
Mean (Standard Deviation) [score on a scale]	0.6 (1.11)

13. Secondary Outcome

Title	Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 52
Description	The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome).
Time Frame	Week 4 - Week 52

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	4
Mean (Standard Deviation) [score on a scale]	0.8 (1.19)

14. Secondary Outcome

Title	Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 28
Description	The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata.
Time Frame	Week 28

Outcome Measure Data

Analysis Population Description

All patients who have a valid assessment at the timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	8
1: Extremely Satisfied	0 0%
2: Moderately Satisfied	2 50%
3: A little Satisfied	1 25%
4: Neither Satisfied or Dissatisfied	1 25%
5: A little Dissatisfied	0 0%
6: Moderately Dissatisfied	1 25%
7: Extremely Dissatisfied	3 75%

15. Secondary Outcome

Title	Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 40
Description	The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata.
Time Frame	Week 40

Outcome Measure Data

Analysis Population Description

All patients who have a valid assessment at the timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	4
1: Extremely Satisfied	0 0%
2: Moderately Satisfied	2 50%
3: A little Satisfied	0 0%
4: Neither Satisfied or Dissatisfied	1 25%
5: A little Dissatisfied	0 0%
6: Moderately Dissatisfied	0 0%
7: Extremely Dissatisfied	1 25%

16. Secondary Outcome

Title	Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 52
Description	The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

All patients who have a valid assessment at the timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	4
1: Extremely Satisfied	0 0%
2: Moderately Satisfied	2 50%
3: A little Satisfied	0 0%
4: Neither Satisfied or Dissatisfied	1 25%
5: A little Dissatisfied	0 0%
6: Moderately Dissatisfied	0 0%
7: Extremely Dissatisfied	1 25%

17. Secondary Outcome

Title	Open Label Extension: Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 24 From Baseline
Description	The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome).
Time Frame	Baseline - Week 24

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	8
Mean (Standard Deviation) [percent change]	6.3 (12.14)

18. Secondary Outcome

Title	Open Label Extension: Severity of Alopecia Tool (SALT Scores), Relative Percent Regrowth (%) at Week 40 From Baseline
Description	The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome).
Time Frame	Baseline - Week 40

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	4
Mean (Standard Deviation) [percent change]	9.0 (13.01)

19. Secondary Outcome

Title	Open Label Extension: The Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 52 From Baseline
Description	The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome).
Time Frame	Baseline - Week 52

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	4
Mean (Standard Deviation) [percent change]	15.5 (16.77)

20. Secondary Outcome

Title	Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 24 Weeks
Description	The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome).
Time Frame	Baseline - Week 24

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	8
Mean (Standard Deviation) [percent change]	7.2 (12.88)

21. Secondary Outcome

Title	Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 40 Weeks
Description	The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome).
Time Frame	Baseline - Week 40

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	4
Mean (Standard Deviation) [percent change]	9.6 (10.81)

22. Secondary Outcome

Title	Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 52 Weeks
Description	The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome).
Time Frame	Baseline - Week 52

Outcome Measure Data

Analysis Population Description

All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.

Arm/Group Title	ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Measure Participants	4
Mean (Standard Deviation) [percent change]	12.2 (11.74)

Adverse Events

Time Frame	Double blind period = 28 days; Open label extension period = 12 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Arm/Group Title	Vehicle Topical Solution		ATI-50002 0.46% Topical Solution		ATI-50002 0.46% Topical Solution OLE
Arm/Group Description	Vehicle Topical Solution applied twice daily during the double blind period of the study.		ATI-50002 0.46% Topical Solution applied twice daily during the double blind period of the study		ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
All Cause Mortality
	Vehicle Topical Solution		ATI-50002 0.46% Topical Solution		ATI-50002 0.46% Topical Solution OLE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/7 (0%)		0/10 (0%)
Serious Adverse Events
	Vehicle Topical Solution		ATI-50002 0.46% Topical Solution		ATI-50002 0.46% Topical Solution OLE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/7 (0%)		1/10 (10%)
Psychiatric disorders
Depression	0/4 (0%)	0	0/7 (0%)	0	1/10 (10%)	1
Other (Not Including Serious) Adverse Events
	Vehicle Topical Solution		ATI-50002 0.46% Topical Solution		ATI-50002 0.46% Topical Solution OLE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/4 (25%)		1/7 (14.3%)		7/10 (70%)
General disorders
Application site erosion	0/4 (0%)	0	0/7 (0%)	0	1/10 (10%)	1
Peripheral swelling	0/4 (0%)	0	0/7 (0%)	0	1/10 (10%)	0
Infections and infestations
Ear infection	0/4 (0%)	0	0/7 (0%)	0	1/10 (10%)	1
Oral herpes	0/4 (0%)	0	0/7 (0%)	0	1/10 (10%)	1
Metabolism and nutrition disorders
Dehydration	0/4 (0%)	0	0/7 (0%)	0	1/10 (10%)	1
Glucose tolerance impaired	0/4 (0%)	0	0/7 (0%)	0	1/10 (10%)	1
Vitamin D deficiency	0/4 (0%)	0	0/7 (0%)	0	1/10 (10%)	1
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome	0/4 (0%)	0	0/7 (0%)	0	1/10 (10%)	1
Nervous system disorders
Migraine	1/4 (25%)	1	0/7 (0%)	0	0/10 (0%)	0
Vascular disorders
Hypertensive urgency	0/4 (0%)	0	1/7 (14.3%)	1	0/10 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.