Lateral Canthal Rhytides With Medium Depth Chemical Peel With or Without Pretreatment With Botulinum Toxin A

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Wrinkles

Intervention / Treatment
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* Drug: Botulinum Toxin
* Procedure: Chemical Peel Only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 30 to 75 years old In good health Has static and dynamic lateral canthal wrinkles (crow's feet) Has the willingness and the ability to understand and provide informed consent and communicate with the investigator Exclusion Criteria: Pregnant or lactating Has received the following treatments: botulinum toxin injections in the past 6 months ablative laser procedure in the past 6 months radiofrequency device treatment in the past 6 months ultrasound device treatment in the past 6 months medium to deep chemical peel in the past 6 months temporary soft tissue augmentation material in the past year semi-permanent soft tissue augmentation material in the past 2 years permanent soft tissue augmentation material Is planning to receive within the next 3 months, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) Has an active infection on their face (excluding mild acne Has a history of neuromuscular disorders Has an allergy to albumin Has an allergy to Aquaphor AND petroleum jelly Has a history of bleeding disorders Is unable to understand the protocol or to give informed consent Has a mental illness

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Botulinum Toxin<br>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. | Drug: Botulinum Toxin<br>* The botulinum toxin will be injected into the wrinkles crow's feet. The injections will take about 10 minutes to complete.<br>* Other names: Botox;|
| Active Comparator: Chemical Peel Only<br>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. | Procedure: Chemical Peel Only<br>* 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.<br>* Other names: TCA peel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttreament Results of Chemical Peel if Botox A is Added as Pre-treatment | 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 wrinkles. | Baseline and 12 weeks | 
| Change From Pre- to Post-treatment Scores of Chemical Peel if Botox A is Added as Pre-treatment | 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 wrinkles; Grade 2 = moderate wrinkles; and Grade 3 = severe wrinkles. | Baseline and 12 weeks |