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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01586819
Other study ID # 203555
Secondary ID
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


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
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