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Completed NCT04485091

TCA Peel and Photobiomodulation for Hand Rejuvenation

Conditions: Skin Aging

Sex: All
Ages: 40 Years – 70 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 42
Sponsor: University of Nove de Julho

Location: University of Nove de Julho (UNINOVE) São Paulo

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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04485091). StuddyBuddy aggregates publicly available trial information.