Phase 2 N=38 Randomized Quadruple-blind Treatment

ET-01 in Subjects With Lateral Canthal Lines, LCL-209

Lateral Canthal Lines, LCL · Crow's Feet

Bottom Line

View on ClinicalTrials.gov: NCT03912805 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: 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 — 3; 1 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: Female
Sponsor: Eirion Therapeutics Inc.
Primary completion: May 2019

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	3; 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	8; 12	—
SECONDARY Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Post Baseline Visit	15; 20	—

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03912805). 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.