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

This study is currently recruiting participants.
Verified October 2012 by Loyola University
Sponsor:
Information provided by (Responsible Party):
Loyola University
ClinicalTrials.gov Identifier:
NCT01586819
First received: November 22, 2011
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Wrinkles
 Drug: Botulinum Toxin Type A
Procedure: Chemical Facial Peel
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Change in outcome of chemical peel if Botox A is added as pre-treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 12
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Botulinum Toxin
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 Type A
The botulinum toxin will be injected into the wrinkles "crow's feet". The injections will take about 10 minutes to complete.
Other Name: Botox
Active Comparator: Chemical Peel Only

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 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.
Other Names:
  • Jessner's peel solution
  • TCA peel

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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586819

Contacts
Contact: Rebecca Tung, MD 708-216-8000 rtung@lumc.edu
Contact: Cathy Kalnicky 708-216-2027 ckalnic@lumc.edu

Locations
United States, Illinois
Loyola Dermatology Recruiting
La Grange Park, Illinois, United States, 60526
Contact: Rebecca Tung, MD     708-327-3480     rtung@lumc.edu    
Principal Investigator: Rebecca Tung, MD            
Sponsors and Collaborators
Loyola University
Investigators
Principal Investigator: Rebecca Tung, MD Loyola University
  More Information

No publications provided

Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT01586819     History of Changes
Other Study ID Numbers: 203555
Study First Received: November 22, 2011
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013