TCA 15% Chemical Peel for Improvement in Hand Lentigines

Study Overview
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Brief Summary
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This study will evaluate the efficacy of the a 15% trichloroacetic acid + 3% glycolic acid peel combination for treatment of lentigines on the hands. This peel combination is sold over the counter. Patients will receive 3 treatments (spaced 4 weeks).

Detailed Description
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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.

Official Title
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Use of TCA 15% + 3% Glycolic Acid Chemical Peel for Improvement in Hand Lentigines

Conditions
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Photoaging, Lentigo

Intervention / Treatment
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* Drug: 15% Trichloroacetic acid + 3% glycolic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment of hand lentigines with 15% trichloroacetic acid + 3% glycolic acid | Drug: 15% Trichloroacetic acid + 3% glycolic acid<br>* Treatment of the hand with an over-the-counter chemical peel containing 15% trichloroacetic acid + 3% glycolic acid<br>* Other names: 15% TCA + 3% GA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in hand lentigines on a 5-point scale | 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 | The GAIS is a validated scale assessing overall change after aesthetic procedures | 4-6 weeks after last treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photoaging, Chemical Peel, Lentigines, Hand Rejuvenation