A Phase 2 interventional study of Botulinum Toxin Type A and Placebo in Lateral Canthal Lines, Crow's Feet and Facial Wrinkles, sponsored by Revance Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-19.
Sponsored by Revance Therapeutics, Inc. · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of 2 sequential doses of RT001 compared to placebo gel to treat moderate to severe lateral canthal lines in adults.
This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the efficacy and safety of a repeat application of RT001 compared to placebo gel in at least 36 subjects with moderate to severe lateral canthal lines (LCL). Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (active versus placebo). At least 36 adult volunteers who have provided informed consent and have met the study eligibility criteria will be enrolled. There will be 18 subjects in each treatment group.
Revance Therapeutics, Inc. is the lead sponsor of 29 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
RT001
Drug: Botulinum Toxin Type A
Placebo
Drug: Placebo
RT001 (Botulinum Toxin Type A Topical Gel) Dose A applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas
Placebo (Dose B) applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line-Rest Severity Scale of the LCA at Baseline compared to Week 8; incidence of treatment emergent AEs
Time frame: Week 8
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line Severity at Smile and at Rest from Baseline to Weeks 2, 4, 6, 8; incidence of treatment emergent AEs
Time frame: Weeks 2, 4, 6, 8
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Revance Therapeutics, Inc.