Clinical trial NCT01586819
Conditions: Wrinkles
Sponsor: Loyola University
Start date: 2011-09-01; Completion date: 2013-05-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
Wrinkling in the skin is caused by habitual facial expressions, aging, sun damage, smoking, poor hydration, and various other factors. There are two major types of wrinkles-dynamic and static. Dynamic wrinkles, which are due to excessive muscle activity, usually of the face, tend to disappear when you relax your facial muscles. The most common of these dynamic wrinkles are frown lines, forehead wrinkles, and eye wrinkles (or crow's feet). However, if the excessive muscle activity is carried on for too long, these do not disappear completely on relaxation, and are thus called static wrinkles. Static wrinkles are formed either by chronic excessive muscle activity or are due to the effects of age and gravity, with a loss of subcutaneous fat. Examples of static wrinkles are the nasolabial folds, which are the deep grooves running from the sides of the nose to the corners of the mouth.

Arms: arm 1: The botulinum toxin will be injected into the wrinkles. The injections will take about 10 minutes to complete. Five follow-up visits will be scheduled at 1-7 days, 7-10 days, 2.5-3 weeks, and 12-14 weeks. arm 2: After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution 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 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.
Interventions: intervention 1: Botulinum Toxin intervention 2: Chemical Peel Only
Intervention descriptions: intervention 1: The botulinum toxin will be injected into the wrinkles "crow's feet". The injections will take about 10 minutes to complete. intervention 2: 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.

Protocol documents: