Phase 2
Completed N=75
ET-01 in Subjects With Lateral Canthal Lines, LCL-208
Lateral Canthal Lines · Crow's Feet
Source: ClinicalTrials.gov NCT03839693 ↗
Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: 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 — 2; 0; 1 Participants
Summary
This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
2; 0; 1 | — |
| SECONDARY Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit |
1; 5; 5 | — |
| SECONDARY Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Time Between Week 4 and Week 12 |
4; 6; 8 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03839693). 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. Informational only — not medical advice.