NCT01586819

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

Completed Phase 3 Results posted Last updated 8 August 2017

What this trial tests

Phase 3 trial testing Botulinum Toxin in Wrinkles in 26 participants. Completed in 1 May 2013.

Timeline

1 September 2011

Primary endpoint
1 May 2013

1 May 2013

Quick facts

Lead sponsor	Loyola University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	1 September 2011
Primary completion	1 May 2013
Estimated completion	1 May 2013
Sites	1 location across United States

Drugs / interventions tested

• Botulinum Toxin — full drug profile →
• Chemical Peel Only

Conditions studied

• Wrinkles — all drugs for Wrinkles →

Sponsor

Loyola University

Who can join

Adults 30 to 75, any sex, with Wrinkles. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Posttreament Results of Chemical Peel if Botox A is Added as Pre-treatment
  Time frame: Baseline and 12 weeks
  The primary objective of this study is to determine if pre-treating the orbicularis oculi muscles with botulinum toxin A improves the results of medium depth chemical peels when treating lateral canthal rhytides. The primary dependent variable is the four-point Facial Wrinkle Severity Scale (FWSS): Grade 0 = no wrinkles; Grade 1 = mild wrinkles; Grade 2 = moderate wrinkles; and Grade 3 = severe wr
• Change From Pre- to Post-treatment Scores of Chemical Peel if Botox A is Added as Pre-treatment
  Time frame: Baseline and 12 weeks
  The primary objective of this study is to determine if there is a significant difference between the change from pre- to post-treatment scores on the facial wrinkle severity scale between the chemical peel control group and the chemical peel plus Botox A treatment group. The primary dependent variable is the four-point Facial Wrinkle Severity Scale (FWSS): Grade 0 = no wrinkles; Grade 1 = mild wri

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Neurotoxin Impurities: A Review of Threats to Efficacy.
   Park JY, Sunga O, Wanitphakdeedecha R, Frevert J. · · 2020 · cited 27× · PMID 32095419 · DOI 10.1097/gox.0000000000002627