CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 26 enrolled
Drug / intervention
Botulinum Toxin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01586819
NCT01586819Phase 3Completed

Treatment of Lateral Canthal Rhytides With Medium Depth Chemical Peel With or Without Pretreatment With Botulinum Toxin A: A Split-face, Rater-blinded Randomized Control Trial

Loyola University·interventional·Posted Apr 27, 2012·Updated Sep 11, 2017

In Brief

A Phase 3 clinical trial evaluating Botulinum Toxin and Chemical Peel Only for Wrinkles. Completed, enrolled 26 participants across 1 site.

Detailed Summary

This study is being done to find out if the use of botulinum toxin prior to a medium strength combination chemical peel (Jessner's peel followed by 35% Trichloroacetic acid peel) will improve the appearance of crow's feet wrinkles when compared to a chemical peel alone. Botulinum toxin type A is a purified substance, derived from a bacteria that block muscular nerve signals. Jessner's Peel, a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%), is a superficial chemical peel. These two products/procedures have been FDA approved to improve the appearance of facial wrinkles.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWrinkles
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 27, 2012
Enrollment StartSep 1, 2011
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.2 years ago

Interventions

Botulinum Toxindrug

The botulinum toxin will be injected into the wrinkles "crow's feet". The injections will take about 10 minutes to complete.

Chemical Peel Onlyprocedure

After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution \[a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%)\] will be applied to the entire face with a large cotton swab. The mixture will be left in place for a few minutes, and then the face will be wiped clean with water. Next, the TCA peel \[35% Trichloroacetic acid\] will be applied around the eyes. After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water. Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly.