TCA 15% Chemical Peel for Improvement in Hand Lentigines

Photoaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05471947
• Other study ID #: SC20220721
• Status: Recruiting
• Phase: Phase 4
• Start date: March 15, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2023
• Source: Main Line Center for Laser Surgery
• Contact: Jessica Plugis
• Phone: 610-645-5551
• Email: jess[@]dermguy.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lentigo
• Photoaging

Intervention

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

Locations

Country	Name	City	State
United States	Main Line Center for Laser Surgery	Ardmore	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Main Line Center for Laser Surgery

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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