A Six Week Topical Cream Study for Subjects With Ichthyosis Vulgaris

• Sponsor: Crown Laboratories, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03173547
• Collaborator: (none)
• Enrollment: 80
• Locations: 7
• Arms: 2
• Actual Duration (Months): 27.2
• Patients Per Site: 11.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The objective of this study is to determine and compare the safety and efficacy of topical 146-9251 cream and vehicle cream applied twice daily for 6 weeks in subjects with moderate to severe ichthyosis vulgaris (IV).

Condition or Disease	Intervention/Treatment	Phase
Ichthyosis Vulgaris	Drug: 146-9251 cream; Drug: Vehicle cream	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Placebo controlledPlacebo controlled
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of 146-9251 Cream Applied Twice-daily for Six Weeks in Subjects With Ichthyosis Vulgaris
• Actual Study Start Date: Apr 25, 2017
• Actual Primary Completion Date: Apr 30, 2019
• Actual Study Completion Date: Jul 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 146-9251 cream Topical cream to be applied two times daily to specified treatment areas for 6 weeks.	Drug: 146-9251 cream; 146-9251 cream contains an active drug and is applied topically.
Placebo Comparator: Vehicle cream Topical cream to be applied two times daily to specified treatment areas for 6 weeks.	Drug: Vehicle cream; Vehicle cream does not contain an active drug and is applied topically.

Outcome Measures

Primary Outcome Measures

1. Treatment Success [Day 43 (6 weeks)]

   Number of participants that show at least a 2 level improvement of overall severity of disease (as measured by IGA score) at 6 weeks. The IGA score is a static evaluation of the overall or "average" degree of severity of a participant's disease, taking into account all of the participant's scaling, erythema, and fissuring in the Treatment Area. IGA was assessed using the following 5-point scale: clear (0), almost clear (1), mild (2), moderate (3), or severe (4).

Other Outcome Measures

1. Adverse Events (AEs) [Day 0 through study completion, average 6 weeks, Day 43.]

   AEs will be assessed by the investigator and the number of participants with any local and systemic AEs will be reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject is a male or female and is at least 12 years old at the time of enrollment.

2. Subject has provided written informed consent/assent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must provide informed consent for the subject. If a subject becomes 18 years of age during the study, the subject must provide written informed consent at that time to continue study participation.

3. Subject and parent/guardian (if applicable) are willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.

4. Subject has a clinical diagnosis of ichthyosis vulgaris involving a minimum of 5% body surface area (BSA). If the subject has IV involving over 40% BSA, the investigator must be able to identify a Treatment Area comprising distinct anatomic units that contains about 40% (excluding the scalp and mucosal areas) as detailed in Section 6.2.

5. Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.

6. Subject is in good general health and free of any disease state or physical condition that might impair evaluation of IV or which, in the investigator's opinion, exposes the subject to an unacceptable risk by study participation.

7. Females must be post-menopausal, surgically sterile, or use an effective method of birth control. , Women of childbearing potential (WOCBP) must have with a negative urine pregnancy test (UPT) at the Baseline Visit.

Exclusion Criteria:

• 1. Subject is pregnant, lactating, or is planning to become pregnant during the study.

1. Subject is currently enrolled in an investigational drug or device study. 3. Subject has used an investigational drug or investigational device treatment within 30 days prior to first application of the test article.

2. Subject has used any topical therapy, including topical corticosteroids or retinoids, in the Treatment Area within 2 weeks prior to the initiation of treatment. Note: a bland emollient may be used in the Treatment Area up to 3 days prior to the initiation of treatment.

3. Subject has used systemic corticosteroids within 4 weeks or retinoids within 24 weeks prior to the initiation of treatment.

4. Subject has stable use of vitamin or herbal supplements for less than 2 weeks prior to the initiation of treatment.

5. Subject has a history of sensitivity to any of the ingredients in the test articles.

6. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.

7. Subject has a physical condition or other dermatologic disorders (e.g., atopic, seborrheic or contact dermatitis, psoriasis, tinea infections, etc.) which, in the investigator's opinion, might impair evaluation of IV, or which exposes the subject to unacceptable risk by study participation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Crown investigative site 01	San Diego	California	United States	92123
2	Crown Investigative site 07	Plainfield	Indiana	United States	46168
3	Crown Investigative site 08	Metairie	Louisiana	United States	70006
4	Crown Investigative site 02	Fridley	Minnesota	United States	55432
5	Crown Investigative site 04	Columbia	Missouri	United States	65212
6	Crown Investigative Site 05	Albuquerque	New Mexico	United States	87106
7	Crown Investigative site 06	High Point	North Carolina	United States	27262

Sponsors and Collaborators

• Crown Laboratories, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 17, 2017

More Information

Publications

None provided.

• Responsible Party: Crown Laboratories, Inc.
• ClinicalTrials.gov Identifier: NCT03173547
• Other Study ID Numbers: 146-9251-201
• First Posted: Jun 2, 2017
• Last Update Posted: Aug 10, 2021
• Last Verified: Aug 1, 2021

• 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: Ichthyosis; Ichthyosis, Lamellar; Ichthyosis Vulgaris

Study Results

Participant Flow

Arm/Group Title	146-9251 Cream	Vehicle Cream
Arm/Group Description	Topical cream to be applied two times daily to specified treatment areas for 6 weeks. 146-9251 cream: 146-9251 cream contains an active drug and is applied topically.	Topical cream to be applied two times daily to specified treatment areas for 6 weeks. Vehicle cream: Vehicle cream does not contain an active drug and is applied topically.
Period Title: Overall Study
STARTED	40	40
COMPLETED	36	38
NOT COMPLETED	4	2

Baseline Characteristics

Arm/Group Title	146-9251 Cream	Vehicle Cream	Total
Arm/Group Description	Topical cream to be applied two times daily to specified treatment areas for 6 weeks. 146-9251 cream: 146-9251 cream contains an active drug and is applied topically.	Topical cream to be applied two times daily to specified treatment areas for 6 weeks. Vehicle cream: Vehicle cream does not contain an active drug and is applied topically.	Total of all reporting groups
Overall Participants	40	40	80
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.8 (19.41)	51.4 (17.42)	53.1 (18.41)
Sex: Female, Male (Count of Participants)
Female	19 47.5%	12 30%	31 38.8%
Male	21 52.5%	28 70%	49 61.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 7.5%	3 7.5%	6 7.5%
Not Hispanic or Latino	37 92.5%	37 92.5%	74 92.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 7.5%	4 10%	7 8.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 5%	5 12.5%	7 8.8%
White	33 82.5%	30 75%	63 78.8%
More than one race	1 2.5%	1 2.5%	2 2.5%
Unknown or Not Reported	1 2.5%	0 0%	1 1.3%
Investigator's Global Assessment (IGA) Score (Count of Participants)
3-Moderate	30 75%	31 77.5%	61 76.3%
4-Severe	10 25%	9 22.5%	19 23.8%

Outcome Measures

1. Primary Outcome

Title	Treatment Success
Description	Number of participants that show at least a 2 level improvement of overall severity of disease (as measured by IGA score) at 6 weeks. The IGA score is a static evaluation of the overall or "average" degree of severity of a participant's disease, taking into account all of the participant's scaling, erythema, and fissuring in the Treatment Area. IGA was assessed using the following 5-point scale: clear (0), almost clear (1), mild (2), moderate (3), or severe (4).
Time Frame	Day 43 (6 weeks)

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	146-9251 Cream	Vehicle Cream
Arm/Group Description	Topical cream to be applied two times daily to specified treatment areas for 6 weeks. 146-9251 cream: 146-9251 cream contains an active drug and is applied topically.	Topical cream to be applied two times daily to specified treatment areas for 6 weeks. Vehicle cream: Vehicle cream does not contain an active drug and is applied topically.
Measure Participants	39	39
Count of Participants [Participants]	21 52.5%	28 70%

2. Other Pre-specified Outcome

Title	Adverse Events (AEs)
Description	AEs will be assessed by the investigator and the number of participants with any local and systemic AEs will be reported.
Time Frame	Day 0 through study completion, average 6 weeks, Day 43.

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	146-9251 Cream	Vehicle Cream
Arm/Group Description	Topical cream to be applied two times daily to specified treatment areas for 6 weeks. 146-9251 cream: 146-9251 cream contains an active drug and is applied topically.	Topical cream to be applied two times daily to specified treatment areas for 6 weeks. Vehicle cream: Vehicle cream does not contain an active drug and is applied topically.
Measure Participants	40	40
Number of Subjects with any AE	9 22.5%	14 35%
Number of Subjects without an AE	31 77.5%	26 65%

Adverse Events

Time Frame	AEs were collected from study day 1 to end of study (week 6).
Arm/Group Title	146-9251 Cream		Vehicle Cream
Arm/Group Description	Topical cream to be applied two times daily to specified treatment areas for 6 weeks. 146-9251 cream: 146-9251 cream contains an active drug and is applied topically.		Topical cream to be applied two times daily to specified treatment areas for 6 weeks. Vehicle cream: Vehicle cream does not contain an active drug and is applied topically.
All Cause Mortality
	146-9251 Cream		Vehicle Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Serious Adverse Events
	146-9251 Cream		Vehicle Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	146-9251 Cream		Vehicle Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		5/40 (12.5%)
Infections and infestations
Nasopharyngitis	0/40 (0%)	0	5/40 (12.5%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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.