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

Loyola University

Status and phase: Completed; Phase 3

Conditions: Wrinkles

Treatments: Drug: Botulinum Toxin; Procedure: Chemical Peel Only

Study type: Interventional

Funder types: Other

Identifiers

NCT01586819

203555

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Botulinum Toxin

Active Comparator group

Description:

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.

Treatment:

Drug: Botulinum Toxin

Chemical Peel Only

Active Comparator group

Description:

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.

Treatment:

Procedure: Chemical Peel Only