ET-01 in Subjects With Lateral Canthal Lines

• Sponsor: Eirion Therapeutics Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03326856
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 5
• Actual Duration (Months): 12.6
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).

Condition or Disease	Intervention/Treatment	Phase
Lateral Canthal Lines; Crow's Feet	Biological: botulinum toxin, Type A; Biological: Vehicle	Phase 2

Detailed Description

This product is being tested for its ability to reduce lateral canthal lines, also known as Crow's Feet.

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: sequential, dose escalating studysequential, dose escalating study
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines
• Actual Study Start Date: Oct 25, 2017
• Actual Primary Completion Date: Jun 11, 2018
• Actual Study Completion Date: Nov 14, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Vehicle Vehicle	Biological: Vehicle; Vehicle Formulation
Experimental: Dose 1 botulinum toxin, Type A, Dose 1	Biological: botulinum toxin, Type A; topical liniment; Other Names: ET-01
Experimental: Dose 2 botulinum toxin, Type A, Dose 2	Biological: botulinum toxin, Type A; topical liniment; Other Names: ET-01
Experimental: Dose 3 botulinum toxin, Type A, Dose 3	Biological: botulinum toxin, Type A; topical liniment; Other Names: ET-01
Experimental: Dose 4 botulinum toxin, Type A, Dose 4	Biological: botulinum toxin, Type A; topical liniment; Other Names: ET-01

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Response Defined as IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2 [Week 4]

   Composite of Investigators Global Assessment & Subject Self-Assessment on contraction. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). The same scale is used for the Investigator's Assessment as well as the Subject's Self Assessment. To count, both assessments (on contraction) have to be "responders" defined as Score ≤ 2.

Secondary Outcome Measures

1. Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 [Week 2, 4, 8,12,18]

   Total number of observations with a Score of ≤ 2 on the Investigators Global Assessment on Contraction, IGA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18.

2. Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 [Week 2, 4, 8,12,18]

   Total number of observations with a Score of ≤ 2 on the Subject Self-Assessment on Contraction, SSA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 25 - 65 years of age

• minimal to moderate Crow's Feet wrinkles at rest

• moderate to severe Crow's Feet wrinkles on contraction

• willingness to refrain from any product affecting skin remodeling

• female subjects must be not pregnant and non-lactating-

Exclusion Criteria:

• history of adverse reactions to any prior botulinum toxin treatments

• history of vaccination or non-response to any prior botulinum toxin treatments

• botulinum toxin treatment in the prior 6 months

• present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or "dry eye"

• history of peri-ocular surgery, brow lift or related procedures

• procedures affecting the lateral canthal region in the prior 12 months

• application of topical prescription medication to the treatment area

• female subjects who are pregnant or are nursing a child

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cary Skin Care	Cary	North Carolina	United States	27519

Sponsors and Collaborators

• Eirion Therapeutics Inc.

Investigators

• Study Director: Klaus Theobald, MD, PhD, Eirion Therapeutics

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 23, 2018

More Information

Publications

None provided.

• Responsible Party: Eirion Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT03326856
• Other Study ID Numbers: ET-01-LCL-206
• First Posted: Oct 31, 2017
• Last Update Posted: Apr 21, 2022
• Last Verified: Apr 1, 2022

• 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: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA

Study Results

Participant Flow

Arm/Group Title	Vehicle	Dose 1	Dose 2	Dose 3	Dose 4
Arm/Group Description	Vehicle Vehicle: Vehicle Formulation	botulinum toxin, Type A, topical liniment Dose 1x on Day 0	botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0	botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0	botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0
Period Title: Overall Study
STARTED	13	9	9	9	8
COMPLETED	12	8	9	9	8
NOT COMPLETED	1	1	0	0	0

Baseline Characteristics

Arm/Group Title	Vehicle	Dose 1	Dose 2	Dose 3	Dose 4	Total
Arm/Group Description	Vehicle Vehicle: Vehicle Formulation	botulinum toxin, Type A, topical liniment Dose 1x on Day 0	botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0	botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0	botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0	Total of all reporting groups
Overall Participants	13	9	9	9	8	48
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	13 100%	9 100%	9 100%	9 100%	8 100%	48 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	11 84.6%	8 88.9%	9 100%	7 77.8%	8 100%	43 89.6%
Male	2 15.4%	1 11.1%	0 0%	2 22.2%	0 0%	5 10.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
White	13 100%	8 88.9%	9 100%	8 88.9%	8 100%	46 95.8%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 11.1%	0 0%	1 11.1%	0 0%	2 4.2%
Region of Enrollment (participants) [Number]
United States	13 100%	9 100%	9 100%	9 100%	8 100%	48 100%
IGA-C (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.5 (0.4)	3.6 (0.5)	3.4 (0.5)	3.4 (0.5)	3.5 (0.5)	3.5 (0.5)
SSA-C (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.5 (0.5)	3.6 (0.5)	3.4 (0.5)	3.5 (0.5)	3.4 (0.5)	3.5 (0.5)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Response Defined as IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2
Description	Composite of Investigators Global Assessment & Subject Self-Assessment on contraction. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). The same scale is used for the Investigator's Assessment as well as the Subject's Self Assessment. To count, both assessments (on contraction) have to be "responders" defined as Score ≤ 2.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

Per Protocol (PP) population defined as all treated subjects who had at least one post-baseline visit. No imputation was performed when only incomplete data were available.

Arm/Group Title	Vehicle	Dose 1	Dose 2	Dose 3	Dose 4
Arm/Group Description	Vehicle Vehicle: Vehicle Formulation	botulinum toxin, Type A, topical liniment Dose 1x on Day 0	botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0	botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0	botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0
Measure Participants	13	8	9	9	8
Count of Participants [Participants]	2 15.4%	3 33.3%	4 44.4%	2 22.2%	1 12.5%

2. Secondary Outcome

Title	Total Number of Observations With a Response Defined as IGA-C Score ≤ 2
Description	Total number of observations with a Score of ≤ 2 on the Investigators Global Assessment on Contraction, IGA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18.
Time Frame	Week 2, 4, 8,12,18

Outcome Measure Data

Analysis Population Description

Per Protocol (PP) population defined as all treated subjects who had at least one post-baseline visit. No imputation was performed when only incomplete data were available.

Arm/Group Title	Vehicle	Dose 1	Dose 2	Dose 3	Dose 4
Arm/Group Description	Vehicle Vehicle: Vehicle Formulation	botulinum toxin, Type A, topical liniment Dose 1x on Day 0	botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0	botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0	botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0
Measure Participants	13	8	9	9	8
Measure Observations	64	40	45	45	40
Count of Units [Observations]	16	17	22	16	9

3. Secondary Outcome

Title	Total Number of Observations With a Response Defined as SSA-C Score ≤ 2
Description	Total number of observations with a Score of ≤ 2 on the Subject Self-Assessment on Contraction, SSA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18.
Time Frame	Week 2, 4, 8,12,18

Outcome Measure Data

Analysis Population Description

Per Protocol (PP) population defined as all treated subjects who had at least one post-baseline visit. No imputation was performed when only incomplete data were available.

Arm/Group Title	Vehicle	Dose 1	Dose 2	Dose 3	Dose 4
Arm/Group Description	Vehicle Vehicle: Vehicle Formulation	botulinum toxin, Type A, topical liniment Dose 1x on Day 0	botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0	botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0	botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0
Measure Participants	13	8	9	9	8
Measure Observations	64	40	45	45	40
Count of Units [Observations]	20	19	26	15	8

Adverse Events

Time Frame	26 Weeks
Arm/Group Title	Vehicle		Dose 1		Dose 2		Dose 3		Dose 4
Arm/Group Description	Vehicle Vehicle: Vehicle Formulation		botulinum toxin, Type A, topical liniment Dose 1x on Day 0		botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0		botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0		botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0
All Cause Mortality
	Vehicle		Dose 1		Dose 2		Dose 3		Dose 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Serious Adverse Events
	Vehicle		Dose 1		Dose 2		Dose 3		Dose 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Vehicle		Dose 1		Dose 2		Dose 3		Dose 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/9 (0%)		1/9 (11.1%)		0/9 (0%)		1/8 (12.5%)
Cardiac disorders
Myocardial infarction	0/13 (0%)	0	0/9 (0%)	0	0/9 (0%)	0	0/9 (0%)	0	1/8 (12.5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	0/13 (0%)	0	0/9 (0%)	0	1/9 (11.1%)	1	0/9 (0%)	0	0/8 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Study Results are considered Confidential Information that may not be published or disclosed without Sponsor's written consent for a period of five (5) years after completion of the Study.