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

Wrinkles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01586819
• Other study ID #: 203555
• Status: Recruiting
• Phase: Phase 3
• First received: November 22, 2011
• Last updated: October 29, 2012
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: October 2012
• Source: Loyola University
• Contact: Rebecca Tung, MD
• Phone: 708-216-8000
• Email: rtung[@]lumc.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wrinkles

Intervention

Drug:
• Botulinum Toxin Type A
The botulinum toxin will be injected into the wrinkles "crow's feet". The injections will take about 10 minutes to complete.

Procedure:
• Chemical Facial Peel
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.

Locations

Country	Name	City	State
United States	Loyola Dermatology	La Grange Park	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in outcome 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.	Baseline and 12 weeks	No