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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01586819
First Posted: April 27, 2012
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rebecca Tung, Loyola University
  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 Procedure: Chemical Peel Only Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Rebecca Tung, Loyola University:

Primary Outcome Measures:
  • Posttreament Results of Chemical Peel if Botox A is Added as Pre-treatment [ Time Frame: Baseline and 12 weeks ]
    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.

  • Change From Pre- to Post-treatment Scores of Chemical Peel if Botox A is Added as Pre-treatment [ Time Frame: Baseline and 12 weeks ]
    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.


Enrollment: 26
Actual Study Start Date: September 2011
Study Completion Date: May 2013
Primary Completion Date: May 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
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 Peel Only
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586819


Locations
United States, Illinois
Loyola Dermatology
La Grange Park, Illinois, United States, 60526
Sponsors and Collaborators
Loyola University
Investigators
Principal Investigator: Rebecca Tung, MD Loyola University
  More Information

Responsible Party: Rebecca Tung, Dermatology Division Director, Loyola University
ClinicalTrials.gov Identifier: NCT01586819     History of Changes
Other Study ID Numbers: 203555
First Submitted: November 22, 2011
First Posted: April 27, 2012
Results First Submitted: April 12, 2017
Results First Posted: September 11, 2017
Last Update Posted: September 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
onabotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents


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