Clinical trial NCT05471947: TCA 15% Chemical Peel for Improvement in Hand Lentigines
Official title: Use of TCA 15% + 3% Glycolic Acid Chemical Peel for Improvement in Hand Lentigines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Photoaging
Lentigo
Keywords: Photoaging
Chemical Peel
Lentigines
Hand Rejuvenation
Lead sponsor: Main Line Center for Laser Surgery
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in hand lentigines on a 5-point scale
timeFrame: 4-6 weeks after last treatment
Secondary outcomes:
measure: Improvement in hand lentigines using the Global Aesthetic Improvement Scale
timeFrame: 4-6 weeks after last treatment
Other outcomes:
Locations:
city: Ardmore
country: United States
facility: Main Line Center for Laser Surgery
state: Pennsylvania
Study officials:
affiliation: Main Line Center for Laser Surgery
name: Kachiu Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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 18.