- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05471947
TCA 15% Chemical Peel for Improvement in Hand Lentigines
Use of TCA 15% + 3% Glycolic Acid Chemical Peel for Improvement in Hand Lentigines
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This clinical investigation is a prospective study consisting of a screening visit, 3 treatment visits, and 1 follow-up visit. Baseline and post-treatment photos will be graded and compared.
A total of 20 patients will be recruited. Following informed consent and screening, subjects' dorsal hands will be photographed.
Patients will receive 3 treatments with the 15% TCA + 3% glycolic acid peel every 4-6 weeks on the dorsal hands. Post-treatment, patients will be instructed to apply Aquaphor to the treated area twice daily for 5 days. Patients' hands will be photographed at each visit.
Four to six weeks after their final treatment, subjects will return for photography.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Ardmore, Pennsylvania, United States, 19003
- Main Line Center for Laser Surgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age >21
- No laser, chemical peel, neuromodulator, filler treatment to the hands in >3 months
- At least 5 lentigines on each hand
Exclusion Criteria:
- Pregnancy
- Breastfeeding
- Allergy to trichloroacetic acid
- Allergy to glycolic acid
- Open wounds on treatment area (hands)
- Active inflammatory disease on treatment area such as atopic dermatitis, psoriasis, dermatomyositis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
Treatment of hand lentigines with 15% trichloroacetic acid + 3% glycolic acid
|
Treatment of the hand with an over-the-counter chemical peel containing 15% trichloroacetic acid + 3% glycolic acid
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement in hand lentigines on a 5-point scale
Time Frame: 4-6 weeks after last treatment
|
Photos will be graded on a 5 point scale (0=no change, 1=1-25% change, 2=26-50% change, 3=51-75% change, 4=76-100% change)
|
4-6 weeks after last treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement in hand lentigines using the Global Aesthetic Improvement Scale
Time Frame: 4-6 weeks after last treatment
|
The GAIS is a validated scale assessing overall change after aesthetic procedures
|
4-6 weeks after last treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kachiu Lee, MD, Main Line Center for Laser Surgery
Publications and helpful links
General Publications
- Cook KK, Cook WR Jr. Chemical peel of nonfacial skin using glycolic acid gel augmented with TCA and neutralized based on visual staging. Dermatol Surg. 2000 Nov;26(11):994-9. doi: 10.1046/j.1524-4725.2000.026011994.x.
- Abd Elazim NE, Makboul R, Botros SN, Awad SM. Cryopeeling versus trichloroacetic acid peeling in the treatment of solar lentigines: Effect on epidermal Langerhans cells. Dermatol Ther. 2020 May;33(3):e13288. doi: 10.1111/dth.13288. Epub 2020 Mar 9.
- Raziee M, Balighi K, Shabanzadeh-Dehkordi H, Robati RM. Efficacy and safety of cryotherapy vs. trichloroacetic acid in the treatment of solar lentigo. J Eur Acad Dermatol Venereol. 2008 Mar;22(3):316-9. doi: 10.1111/j.1468-3083.2007.02409.x. Epub 2007 Oct 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SC20220721
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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