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COMPLETED
NCT04485091
PHASE2

TCA Peel and Photobiomodulation for Hand Rejuvenation

Sponsor: University of Nove de Julho

View on ClinicalTrials.gov

Summary

Photodamage is a growing concern in contemporary society because promotes early skin aging and different pathologies resulting from prolonged and repeated exposure to ultraviolet solar radiation, which is considered the main extrinsic factor of this process. Affected by radiation, the hands play an important role in the manifestation and visibility of aging, as they are very exposed body regions. The study proposal is developed by the potential mechanism of tissue repair, skin rejuvenation, anti-inflammatory and analgesic effects of photobiomodulation, complementing the benefits of chemical peel. The main objective of this randomized, controlled, double-blind clinical trial is to compare the photorejuvenating effects of 20% trichloroacetic acid (TCM) peel applied alone and the effects of the association of 20% TCM peel with 660nm light emitting diode (LED) photobiomodulation (PBM) in the treatment of the back of the hands. Participants will be divided into 2 groups and will receive different therapies according to the allocation group. Group A will be subjected to 04 chemical peel sessions of 20% TCM and PBM. Group B will also receive the 04 chemical peel sessions of 20% TCM with PBM simulation. The application sessions will be monthly and the consultations for fortnightly evaluations. Analysis of photoaging characteristics such as fine and coarse wrinkles, dyschromias and global assessment of the back of the hands will be carried out using periodic standardized photographs. A visual-analog pain scale and a 5-point Likert scale will also be applied regularly to assess participants' satisfaction.

Official title: Association of Trichloroacetic Acid Peel With Photobiomodulation in the Treatment of Skin Photoaging of the Hands: a Study Protocol for a Controlled, Randomized, Double-blind Clinical Trial.

Key Details

Gender

All

Age Range

40 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2021-10-01

Completion Date

2022-02-28

Last Updated

2026-07-29

Healthy Volunteers

No

Conditions

Interventions

COMBINATION_PRODUCT

20% TCM and PBM

The chemical peel (20% TCM) will be carried out monthly, totaling 04 sessions. The application of photobiomodulation (PBM) will start shortly after the observation of frosting level I, which characterizes an exfoliation of superficial depth. Although the application sessions take place monthly, medical evaluations will be carried out fortnightly for the other orientations, filling in scales and photographs. For the PBM, a LED device with an irradiance of 10 milliwatts per square centimeter (mW/cm²) in continuous operation mode and a wavelength of 660 nm will be used. It will provide an energy density of 4 J/cm² within 400 seconds of irradiation.

OTHER

20% TCM and PBM placebo

The chemical peel (20% TCM) will be carried out monthly, totaling 04 sessions. The application of photobiomodulation (PBM) will be simulated soon after the observation of frosting level I. The patient will not be aware of the simulation of the procedure. Although the application sessions take place monthly, medical evaluations will be carried out fortnightly for the other orientations, filling in scales and photographs.

Locations (1)

University of Nove de Julho (UNINOVE)

São Paulo, Brazil