ET-01 in Subjects With Lateral Canthal Lines, LCL-208

• Sponsor: Eirion Therapeutics Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03839693
• Collaborator: (none)
• Enrollment: 75
• Locations: 5
• Arms: 3
• Actual Duration (Months): 11.1
• Patients Per Site: 15
• Patients Per Site Per Month: 1.4

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: 75 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: sequential cohort, dose escalating studysequential cohort, 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 16, 2018
• Actual Primary Completion Date: Apr 18, 2019
• Actual Study Completion Date: Sep 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Vehicle Vehicle	Biological: Vehicle; Vehicle Formulation
Experimental: ET-01 345U botulinum toxin, Type A, Dose 1, 345 U	Biological: botulinum toxin, Type A; topical liniment; Other Names: ET-01
Experimental: ET-01 1100U botulinum toxin, Type A, Dose 2, 1100 U	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 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 Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit [Week 1, 2, 4, 8,12,18, and 26]

   Total number of observations with a change in the Investigators Global Assessment on Contraction, IGA-C, and 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 a change by at least two ordinals in both assessments. The observation period includes all post-baseline visits from Week 1 to Week 26.

2. Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Time Between Week 4 and Week 12 [Week 4, 8,and 12]

   Total number of observations with a change by at least two ordinals in 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 an improvement ≥ 2 score points. The observation period covers the time time of expected peak efficacy from Week 4 to Week 12.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• females 25 - 65 years of age

• minimal to moderate Crow's Feet wrinkles at rest

• moderate to severe Crow's Feet on contraction

• adequate vision to assess facial wrinkles in a mirror

• willingness to refrain from products affecting skin remodeling

• female subjects must be not pregnant and non-lactating

• subjects should be in good general health

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	Synexus, Inc.	Pinellas Park	Florida	United States	33781
3	Forefront Dermatology	Louisville	Kentucky	United States	40202
4	Westlake Dermatology Clinical Research Center	Austin	Texas	United States	78746
5	Virginia Clinical Research, Inc.	Norfolk	Virginia	United States	23502

Sponsors and Collaborators

• Eirion Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 6, 2018

More Information

Publications

None provided.

• Responsible Party: Eirion Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT03839693
• Other Study ID Numbers: ET-01-LCL-208
• First Posted: Feb 15, 2019
• Last Update Posted: Aug 23, 2022
• Last Verified: Jul 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 five medical centers between October 2018 and March 2019.
Pre-assignment Detail	A total of N=88 subjects were screened; N=75 were found eligible and were randomized and treated.

Arm/Group Title	Vehicle	ET-01 345U	ET-01 1100U
Arm/Group Description	Vehicle Vehicle: Vehicle Formulation	botulinum toxin, Type A, Dose 1, 345U lower dose of botulinum toxin, Type A: topical liniment	botulinum toxin, Type A, Dose 2, 1100U higher dose of botulinum toxin, Type A: topical liniment
Period Title: Overall Study
STARTED	25	30	20
COMPLETED	23	28	16
NOT COMPLETED	2	2	4

Baseline Characteristics

Arm/Group Title	Vehicle	ET-01 345U	ET-01 1100U	Total
Arm/Group Description	Vehicle Vehicle: Vehicle Formulation	botulinum toxin, Type A, Lower Dose 1, 345U botulinum toxin, Type A: topical liniment	botulinum toxin, Type A, Higher Dose 2, 1100U botulinum toxin, Type A: topical liniment	Total of all reporting groups
Overall Participants	25	30	20	75
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	23 92%	29 96.7%	19 95%	71 94.7%
>=65 years	2 8%	1 3.3%	1 5%	4 5.3%
Sex: Female, Male (Count of Participants)
Female	25 100%	30 100%	20 100%	75 100%
Male	0 0%	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 8%	4 13.3%	6 30%	12 16%
Not Hispanic or Latino	22 88%	25 83.3%	14 70%	61 81.3%
Unknown or Not Reported	1 4%	1 3.3%	0 0%	2 2.7%
IGA-C (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.3 (0.4)	3.5 (0.5)	3.5 (0.5)	3.4 (0.5)
SSA-C (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.5 (0.5)	3.7 (0.5)	3.8 (0.4)	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	ET-01 345U	ET-01 1100U
Arm/Group Description	Vehicle Vehicle: Vehicle Formulation	botulinum toxin, Type A, Dose 1 botulinum toxin, Type A: topical liniment	botulinum toxin, Type A, Dose 2 botulinum toxin, Type A: topical liniment
Measure Participants	23	30	19
Count of Participants [Participants]	2 8%	0 0%	1 5%

2. Secondary Outcome

Title	Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit
Description	Total number of observations with a change in the Investigators Global Assessment on Contraction, IGA-C, and 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 a change by at least two ordinals in both assessments. The observation period includes all post-baseline visits from Week 1 to Week 26.
Time Frame	Week 1, 2, 4, 8,12,18, and 26

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	ET-01 345U	ET-01 1100U
Arm/Group Description	Vehicle Vehicle: Vehicle Formulation	botulinum toxin, Type A, Dose 1 botulinum toxin, Type A: topical liniment	botulinum toxin, Type A, Dose 2 botulinum toxin, Type A: topical liniment
Measure Participants	25	30	20
Measure Observations	162	202	131
Count of Units [Observations]	1	5	5

3. Secondary Outcome

Title	Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Time Between Week 4 and Week 12
Description	Total number of observations with a change by at least two ordinals in 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 an improvement ≥ 2 score points. The observation period covers the time time of expected peak efficacy from Week 4 to Week 12.
Time Frame	Week 4, 8,and 12

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	ET-01 345U	ET-01 1100U
Arm/Group Description	Vehicle Vehicle: Vehicle Formulation	botulinum toxin, Type A, Lower Dose 1 botulinum toxin, Type A: topical liniment	botulinum toxin, Type A, Higher Dose 2 botulinum toxin, Type A: topical liniment
Measure Participants	23	30	19
Measure Observations	68	88	57
Count of Units [Observations]	4	6	8

Adverse Events

Time Frame	26 weeks
Arm/Group Title	Vehicle		ET-01 345U		ET-01 1100U
Arm/Group Description	Vehicle Vehicle: Vehicle Formulation		botulinum toxin, Type A, Lower Dose 1, 345U botulinum toxin, Type A: topical liniment		botulinum toxin, Type A, Higher Dose 2, 1100U botulinum toxin, Type A: topical liniment
All Cause Mortality
	Vehicle		ET-01 345U		ET-01 1100U
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/30 (0%)		0/20 (0%)
Serious Adverse Events
	Vehicle		ET-01 345U		ET-01 1100U
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/30 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Vehicle		ET-01 345U		ET-01 1100U
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/25 (52%)		4/30 (13.3%)		5/20 (25%)
Ear and labyrinth disorders
Ear infection	1/25 (4%)	1	0/30 (0%)	0	0/20 (0%)	0
Endocrine disorders
Thyroiditis subacute	0/25 (0%)	0	0/30 (0%)	0	1/20 (5%)	1
Eye disorders
Blepharitis	1/25 (4%)	1	0/30 (0%)	0	0/20 (0%)	0
Hordeolum	4/25 (16%)	4	0/30 (0%)	0	0/20 (0%)	0
Gastrointestinal disorders
Constipation	1/25 (4%)	1	0/30 (0%)	0	0/20 (0%)	0
Cough	0/25 (0%)	0	0/30 (0%)	0	1/20 (5%)	1
Dyspepsia	0/25 (0%)	0	0/30 (0%)	0	1/20 (5%)	1
General disorders
Headache	2/25 (8%)	2	0/30 (0%)	0	0/20 (0%)	0
Infections and infestations
Influenza	1/25 (4%)	1	0/30 (0%)	0	0/20 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	0/25 (0%)	0	0/30 (0%)	0	1/20 (5%)	1
Nervous system disorders
Nausea	1/25 (4%)	1	1/30 (3.3%)	1	0/20 (0%)	0
Renal and urinary disorders
Cystitis	0/25 (0%)	0	0/30 (0%)	0	1/20 (5%)	1
Reproductive system and breast disorders
Endometrial ablation	1/25 (4%)	1	0/30 (0%)	0	0/20 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dry throat	0/25 (0%)	0	0/30 (0%)	0	1/20 (5%)	1
Nasopharyngitis	2/25 (8%)	2	1/30 (3.3%)	1	4/20 (20%)	4
Sinusitis	2/25 (8%)	2	0/30 (0%)	0	0/20 (0%)	0
Upper respiratory tract infection	2/25 (8%)	2	2/30 (6.7%)	2	1/20 (5%)	1
Skin and subcutaneous tissue disorders
Application site pruritus	1/25 (4%)	1	0/30 (0%)	0	0/20 (0%)	0
Dermatitis contact	1/25 (4%)	1	0/30 (0%)	0	0/20 (0%)	0
Nail dystrophy	1/25 (4%)	1	0/30 (0%)	0	0/20 (0%)	0
Rhinitis allergic	1/25 (4%)	1	0/30 (0%)	0	0/20 (0%)	0
Skin discolouration	1/25 (4%)	1	0/30 (0%)	0	0/20 (0%)	0
Surgical and medical procedures
Endodontic procedure	1/25 (4%)	1	0/30 (0%)	0	0/20 (0%)	0
Mammoplasty	1/25 (4%)	1	0/30 (0%)	0	0/20 (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.