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TCA 15% Chemical Peel for Improvement in Hand Lentigines

Primary Purpose

Photoaging, Lentigo

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

15% Trichloroacetic acid + 3% glycolic acid

About this trial

This is an interventional treatment trial for Photoaging focused on measuring Photoaging, Chemical Peel, Lentigines, Hand Rejuvenation

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Main Line Center for Laser SurgeryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Improvement in hand lentigines using the Global Aesthetic Improvement Scale

The GAIS is a validated scale assessing overall change after aesthetic procedures

Full Information

NCT ID

NCT05471947

First Posted

July 21, 2022

Last Updated

April 11, 2023

Sponsor

Main Line Center for Laser Surgery

1. Study Identification

Unique Protocol Identification Number

NCT05471947

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 15, 2023 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Main Line Center for Laser Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Photoaging, Lentigo

Keywords

Photoaging, Chemical Peel, Lentigines, Hand Rejuvenation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

15% Trichloroacetic acid + 3% glycolic acid

Other Intervention Name(s)

15% TCA + 3% GA

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement in hand lentigines on a 5-point scale

Description

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)

Time Frame

4-6 weeks after last treatment

Secondary Outcome Measure Information:

Title

Improvement in hand lentigines using the Global Aesthetic Improvement Scale

Description

The GAIS is a validated scale assessing overall change after aesthetic procedures

Time Frame

4-6 weeks after last treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jessica Plugis

Phone

610-645-5551

jess@dermguy.com

First Name & Middle Initial & Last Name or Official Title & Degree

Kachiu Lee, MD

Phone

610-645-5551

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kachiu Lee, MD

Organizational Affiliation

Main Line Center for Laser Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Main Line Center for Laser Surgery

City

Ardmore

State/Province

Pennsylvania

ZIP/Postal Code

19003

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jessica Plugis

Phone

610-645-5551

jess@dermguy.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

11096382

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.

Results Reference

result

PubMed Identifier

32118343

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.

Results Reference

result

PubMed Identifier

18021205

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.

Results Reference

result

Learn more about this trial

TCA 15% Chemical Peel for Improvement in Hand Lentigines

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