ET-01 in Subjects With Lateral Canthal Lines, LCL-207

• Sponsor: Eirion Therapeutics Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03655691
• Collaborator: (none)
• Enrollment: 79
• Locations: 6
• Arms: 3
• Actual Duration (Months): 7.8
• Patients Per Site: 13.2
• Patients Per Site Per Month: 1.7

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: Vehicle; Biological: botulinum toxin, Type A; Biological: botulinum toxin, Type A	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: 79 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: parallel dose groupsparallel dose groups
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: different doses are packaged in identical containers
• Primary Purpose: Treatment
• Official Title: Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines
• Actual Study Start Date: Aug 16, 2018
• Actual Primary Completion Date: Nov 9, 2018
• Actual Study Completion Date: Apr 11, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Vehicle Vehicle / Placebo formulation	Biological: Vehicle; Vehicle Formulation
Experimental: Dose 1 lower dose of ET-01	Biological: botulinum toxin, Type A; botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline; Other Names: ET-01
Experimental: Dose 2 higher dose of ET-01	Biological: botulinum toxin, Type A; botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline; Other Names: ET-01

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Response Defined as Change in IGA-C (Investigators Global Assessment) Score by at Least 2 Ordinals From Baseline to Week 4 [Week 4]

   Investigators Global Assessment of the Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). Response is defined as change by at least two ordinals from Baseline to Week 4.

Secondary Outcome Measures

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

   Total number of observations with a Score of ≤ 2 on the Subjects 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	Baumann Cosmetic & Research Institute	Miami	Florida	United States	33137
2	Radiant Research, Inc.	Pinellas Park	Florida	United States	33781
3	Research Institute of the Southeast, LLC	West Palm Beach	Florida	United States	33401
4	Dermatology NOLA Inc.	Metairie	Louisiana	United States	70006
5	Westlake Dermatology Clinical Research Center	Austin	Texas	United States	78746
6	Virginia Clinical Research, Inc.	Norfolk	Virginia	United States	23502

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 - Aug 6, 2018

More Information

Publications

None provided.

• Responsible Party: Eirion Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT03655691
• Other Study ID Numbers: ET-01-LCL-207
• First Posted: Aug 31, 2018
• 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

Recruitment Details	Participants were recruited from six medical centers between August and October 2018.
Pre-assignment Detail	A total of N=104 subjects were screened; N=80 were found eligible; N=1 subject withdrew consent prior to treatment assignment; N=79 were randomized.

Arm/Group Title	Vehicle	Dose 1	Dose 2
Arm/Group Description	Vehicle / Placebo formulation Vehicle: Vehicle Formulation, administered once, topically, at Baseline	lower dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline	higher dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline
Period Title: Overall Study
STARTED	26	26	27
COMPLETED	24	23	24
NOT COMPLETED	2	3	3

Baseline Characteristics

Arm/Group Title	Vehicle	Dose 1	Dose 2	Total
Arm/Group Description	Vehicle / Placebo formulation Vehicle: Vehicle Formulation, administered once, topically, at Baseline	lower dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline	higher dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, Dose 2, administered once, topically, at Baseline	Total of all reporting groups
Overall Participants	26	26	27	79
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	25 96.2%	26 100%	26 96.3%	77 97.5%
>=65 years	1 3.8%	0 0%	1 3.7%	2 2.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.3 (9.0)	51.3 (8.2)	51.4 (7.3)	50.6 (8.1)
Sex: Female, Male (Count of Participants)
Female	20 76.9%	24 92.3%	21 77.8%	65 82.3%
Male	6 23.1%	2 7.7%	6 22.2%	14 17.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	2 7.4%	2 2.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	1 3.8%	0 0%	2 7.4%	3 3.8%
White	22 84.6%	24 92.3%	23 85.2%	69 87.3%
More than one race	3 11.5%	2 7.7%	0 0%	5 6.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	26 100%	26 100%	27 100%	79 100%
IGA-C (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.7 (0.4)	3.6 (0.5)	3.6 (0.5)	3.6 (0.5)
SSA-C (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.5 (0.5)	3.8 (0.4)	3.6 (0.5)	3.6 (0.5)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Response Defined as Change in IGA-C (Investigators Global Assessment) Score by at Least 2 Ordinals From Baseline to Week 4
Description	Investigators Global Assessment of the Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). Response is defined as change by at least two ordinals from Baseline to Week 4.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

Intent-To-Treat (ITT) 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
Arm/Group Description	Vehicle / Placebo formulation Vehicle: Vehicle Formulation, administered once, topically, at Baseline	lower dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline	higher dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline
Measure Participants	24	26	26
Count of Participants [Participants]	4 15.4%	1 3.8%	3 11.1%

2. Secondary Outcome

Title	Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 at Any Time Between Week 2 and Week 18
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, and 18

Outcome Measure Data

Analysis Population Description

Intent-To-Treat (ITT) 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
Arm/Group Description	Vehicle / Placebo formulation Vehicle: Vehicle Formulation, administered once, topically, at Baseline	lower dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline	higher dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline
Measure Participants	24	26	26
Measure Observations	146	151	152
Count of Units [Observations]	33	18	44

3. Secondary Outcome

Title	Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 at Any Time Between Week 2 and Week 18
Description	Total number of observations with a Score of ≤ 2 on the Subjects 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, and 18

Outcome Measure Data

Analysis Population Description

Intent-To-Treat (ITT) 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
Arm/Group Description	Vehicle / Placebo formulation Vehicle: Vehicle Formulation, administered once, topically, at Baseline	lower dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline	higher dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline
Measure Participants	24	26	26
Measure Observations	146	151	152
Count of Units [Observations]	30	8	17

Adverse Events

Time Frame	26 Weeks
Arm/Group Title	Vehicle		Dose 1		Dose 2
Arm/Group Description	Vehicle / Placebo formulation Vehicle: Vehicle Formulation		lower dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, Dose 1		higher dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, Dose 2
All Cause Mortality
	Vehicle		Dose 1		Dose 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)		1/27 (3.7%)
Serious Adverse Events
	Vehicle		Dose 1		Dose 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)		3/27 (11.1%)
Infections and infestations
Bronchitis	0/26 (0%)	0	0/26 (0%)	0	1/27 (3.7%)	1
Injury, poisoning and procedural complications
Accidental death	0/26 (0%)	0	0/26 (0%)	0	1/27 (3.7%)	1
Nervous system disorders
Depression	0/26 (0%)	0	0/26 (0%)	0	1/27 (3.7%)	1
Other (Not Including Serious) Adverse Events
	Vehicle		Dose 1		Dose 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/26 (15.4%)		3/26 (11.5%)		2/27 (7.4%)
Gastrointestinal disorders
Large intestine benign neoplasm	2/26 (7.7%)	2	0/26 (0%)	0	0/27 (0%)	0
Infections and infestations
Nasopharyngitis	1/26 (3.8%)	1	1/26 (3.8%)	1	1/27 (3.7%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	0/26 (0%)	0	1/26 (3.8%)	1	1/27 (3.7%)	1
Skin and subcutaneous tissue disorders
Erythema	1/26 (3.8%)	1	1/26 (3.8%)	1	0/27 (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.