Phase 2
N=48
ET-01 in Subjects With Lateral Canthal Lines
Lateral Canthal Lines · Crow's Feet
Bottom Line
View on ClinicalTrials.gov: NCT03326856 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Number of Participants With a Response Defined as IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2 — 2; 3; 4; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- botulinum toxin, Type A (Biological); Vehicle (Biological)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Eirion Therapeutics Inc.
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Response Defined as IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2 |
2; 3; 4; 2; 1 | — |
| SECONDARY Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 |
16; 17; 22; 16; 9 | — |
| SECONDARY Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 |
20; 19; 26; 15; 8 | — |
Summary
This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03326856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.