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

NCT01586819 | Completed Phase 3 Results

• 1 other identifier: 203555
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wrinkles

Outcome Measures

Primary Outcomes (2)

• Posttreament Results 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. 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.

  Baseline and 12 weeks

• Change From Pre- to Post-treatment Scores of Chemical Peel if Botox A is Added as Pre-treatment

  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.

  Baseline and 12 weeks

Study Arms (2)

Botulinum Toxin

ACTIVE COMPARATOR

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

Chemical Peel Only

ACTIVE COMPARATOR

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

Interventions

Botulinum Toxin DRUG

The botulinum toxin will be injected into the wrinkles "crow's feet". The injections will take about 10 minutes to complete.

Also known as: Botox

Botulinum Toxin

Chemical Peel Only PROCEDURE

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.

Also known as: Jessner's peel solution, TCA peel

Chemical Peel Only

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola Dermatology

La Grange Park, Illinois, 60526, United States

Location

MeSH Terms

Interventions

Botulinum Toxins; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Limitations and Caveats

There are no limitations or caveats to disclose.

Results Point of Contact

• Title: Rebecca Tung, M.D.
• Organization: Loyola University Chicago

rtung@lumc.edu

708-216-8000

Study Officials

• Rebecca Tung, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology Division Director

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: April 27, 2012
• Study Start: September 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 11, 2017
• Results First Posted: September 11, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)