TCA Peel and Photobiomodulation for Hand Rejuvenation

NCT04485091 | Completed Phase 2

• 1 other identifier: PHOTOACID
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Aging

Keywords

Photoaging; Photodamage; Chemical peel; Photobiomodulation; Phototherapy; Skin rejuvenation; Rejuvenation of hands; low-level laser therapy (LLLT); light emitting diode (LED)

Outcome Measures

Primary Outcomes (1)

• Fine wrinkles

  The back of both hands of the participants will be photographed before starting the skin preparation for the experiments (day 0). Standardized photo sessions according to the Clinical Photography Committee of the Plastic Surgery Educational Foundation will also take place in each biweekly medical evaluation to monitor the evolution of photorejuvenation. All photographs will be evaluated after 30 days of the last treatment session by 02 independent experts in 04 distinct clinical signs about photoaging: fine wrinkles, coarse wrinkles, abnormal pigmentation and global evaluation. The global evaluation is used to have a general impression of the photodamage, as shown by Mckenzie, 2011. The 04 clinical signs will be characterized separately by a scale from 0 to 9, with 0 representing the absence of changes and 9 representing the maximum of changes. The Kappa coefficient will be used to measure agreement between the examiners.

  6 months

Secondary Outcomes (5)

• Coarse wrinkles

  6 months

• Abnormal pigmentation

  6 months

• Global evaluation

  6 months

• Visual Analog Scale (VAS) for pain

  6 months

• Scale of Satisfaction

  6 months

Study Arms (2)

Group A: 20% TCM and PBM

EXPERIMENTAL

21 participants will be included in this group. Application of chemical peel of 20% trichloroacetic acid solution (TCM) in association with photobiomodulation (PBM) with red spectrum LED (660nm) on the back of the hands.

Combination Product: 20% TCM and PBM

Group B: 20% TCM and PBM placebo

PLACEBO COMPARATOR

21 participants will be included in this group. Application of chemical peel of 20% trichloroacetic acid solution (TCM) in association with simulated photobiomodulation on the back of the hands.

Other: 20% TCM and PBM placebo

Interventions

20% TCM and PBM COMBINATION_PRODUCT

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.

Group A: 20% TCM and PBM

20% TCM and PBM placebo OTHER

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.

Group B: 20% TCM and PBM placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals without comorbidities or with controlled comorbidities (ASA I and ASA II physical status classification).
• Participants must also have skin phototype I, II or III according to the Fitzpatrick classification.

You may not qualify if:

• Smoking, alcoholic, oncological, malnourished, anemic, pregnant, immunosuppressed participants.
• Patients with blood dyscrasias, psychiatric illnesses, collagen diseases (even with proper control), photosensitivity, individuals undergoing chemotherapy or hormone therapy and with scar changes (keloids and hypertrophic scar).
• Also excluded from the study are individuals who performed previous aesthetic procedures on their hands and use of medications that influence skin color, such as amiodarone, tetracyclines, tricyclic antidepressants, phenothiazines and others.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

University of Nove de Julho (UNINOVE)

São Paulo, 01504-001, Brazil

Location

Related Publications (8)

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  PMID: 8980279 BACKGROUND

• Zhang S, Duan E. Fighting against Skin Aging: The Way from Bench to Bedside. Cell Transplant. 2018 May;27(5):729-738. doi: 10.1177/0963689717725755. Epub 2018 Apr 25.

  PMID: 29692196 BACKGROUND

• Blanpain C, Fuchs E. Epidermal stem cells of the skin. Annu Rev Cell Dev Biol. 2006;22:339-73. doi: 10.1146/annurev.cellbio.22.010305.104357.

  PMID: 16824012 BACKGROUND

• Soleymani T, Lanoue J, Rahman Z. A Practical Approach to Chemical Peels: A Review of Fundamentals and Step-by-step Algorithmic Protocol for Treatment. J Clin Aesthet Dermatol. 2018 Aug;11(8):21-28. Epub 2018 Aug 1.

  PMID: 30214663 BACKGROUND

• Lindley LE, Stojadinovic O, Pastar I, Tomic-Canic M. Biology and Biomarkers for Wound Healing. Plast Reconstr Surg. 2016 Sep;138(3 Suppl):18S-28S. doi: 10.1097/PRS.0000000000002682.

  PMID: 27556760 BACKGROUND

• Yaar M, Gilchrest BA. Photoageing: mechanism, prevention and therapy. Br J Dermatol. 2007 Nov;157(5):874-87. doi: 10.1111/j.1365-2133.2007.08108.x. Epub 2007 Aug 17.

  PMID: 17711532 BACKGROUND

• Avci P, Gupta A, Sadasivam M, Vecchio D, Pam Z, Pam N, Hamblin MR. Low-level laser (light) therapy (LLLT) in skin: stimulating, healing, restoring. Semin Cutan Med Surg. 2013 Mar;32(1):41-52.

  PMID: 24049929 BACKGROUND

• McKenzie NE, Saboda K, Duckett LD, Goldman R, Hu C, Curiel-Lewandrowski CN. Development of a photographic scale for consistency and guidance in dermatologic assessment of forearm sun damage. Arch Dermatol. 2011 Jan;147(1):31-6. doi: 10.1001/archdermatol.2010.392.

  PMID: 21242389 RESULT

MeSH Terms

Interventions

phytobacteriomycin

Study Officials

• Marcos Momolli

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-supervisor

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 24, 2020
• Study Start: October 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: February 28, 2022
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)