NCT05471947

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

July 21, 2022

Last Update Submit

March 14, 2025

Conditions

PhotoagingLentigo

Keywords

PhotoagingChemical PeelLentiginesHand Rejuvenation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Improvement in hand lentigines using the Global Aesthetic Improvement Scale

    4-6 weeks after last treatment

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment of hand lentigines with 15% trichloroacetic acid + 3% glycolic acid

Drug: 15% Trichloroacetic acid + 3% glycolic acid

Interventions

15% Trichloroacetic acid + 3% glycolic acidDRUG

Treatment of the hand with an over-the-counter chemical peel containing 15% trichloroacetic acid + 3% glycolic acid

Also known as: 15% TCA + 3% GA
Treatment

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>21
  • No laser, chemical peel, neuromodulator, filler treatment to the hands in \>3 months
  • At least 5 lentigines on each hand

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Main Line Center for Laser Surgery

Ardmore, Pennsylvania, 19003, United States

Location

Related Publications (4)

  • 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: 11096382RESULT

  • 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: 32118343RESULT

  • 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: 18021205RESULT

  • 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: 38460193DERIVED

MeSH Terms

Conditions

Lentigo

Interventions

Trichloroacetic Acidglycolic acid

Condition Hierarchy (Ancestors)

MelanosisHyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ChloroacetatesAcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydrocarbons, ChlorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Kachiu Lee, MD

    Main Line Center for Laser Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 25, 2022

Study Start

March 15, 2023

Primary Completion

December 30, 2023

Study Completion

December 1, 2024

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)