TCA 15% Chemical Peel for Improvement in Hand Lentigines

NCT05471947 — Phase 4, Completed, 20 participants, Main Line Center for Laser Surgery

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

Registry	NCT05471947
Status	Completed
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	20 (Actual)
Sponsor	Main Line Center for Laser Surgery (Other)
Conditions	Photoaging, Lentigo
Interventions	15% Trichloroacetic acid + 3% glycolic acid (Drug)
Dates	start 2023-03-15, primary completion 2023-12-30, completion 2024-12-01, first posted 2022-07-25, last updated 2025-03-17
Locations	1 site in United States

-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).

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Treatment	Experimental	Drug: 15% Trichloroacetic acid + 3% glycolic acid	Treatment of hand lentigines with 15% trichloroacetic acid + 3% glycolic acid

15% Trichloroacetic acid + 3% glycolic acid (Drug), also known as 15% TCA + 3% GA: Treatment of the hand with an over-the-counter chemical peel containing 15% trichloroacetic acid + 3% glycolic acid

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 22 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Main Line Center for Laser Surgery	Ardmore, Pennsylvania	United States

+Publications

Results publication: 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. PMID 11096382
Results publication: 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. PMID 32118343
Results publication: 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. PMID 18021205
Results publication: Alajmi A, Niaz G, Chen C, Lee K. A 15% Trichloroacetic Acid + 3% Glycolic Acid Chemical Peel Series Improves Appearance of Hand Lentigines: An Evaluator-Blinded, Split-Hand Prospective Trial. Dermatol Surg. 2024 May 1;50(5):467-470. doi: 10.1097/DSS.0000000000004114. Epub 2024 Mar 8. PMID 38460193

+Investigators

Kachiu Lee, MD, Principal investigator, Main Line Center for Laser Surgery