TCA 15% Chemical Peel for Improvement in Hand Lentigines

Phase 4

Completed

• Conditions: Lentigo; Photoaging
• Interventions: Drug: 15% Trichloroacetic acid + 3% glycolic acid

• Registration Number: NCT05471947
• Lead Sponsor: Main Line Center for Laser Surgery

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-07-21
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-25
• Study Start: 2023-03-15
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	15% Trichloroacetic acid + 3% glycolic acid	Treatment of hand lentigines with 15% trichloroacetic acid + 3% glycolic acid

Primary Outcome Measures

Name	Time	Method
Improvement in hand lentigines on a 5-point scale	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)

Secondary Outcome Measures

Name	Time	Method
Improvement in hand lentigines using the Global Aesthetic Improvement Scale	4-6 weeks after last treatment	The GAIS is a validated scale assessing overall change after aesthetic procedures

Trial Locations

Locations (1)

Main Line Center for Laser Surgery; 🇺🇸 Ardmore, Pennsylvania, United States