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.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Nove de Julho
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Fine wrinkles
Study Overview
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.
Detailed Description
Participants will be divided into two groups for the treatment of photoaging of hands:
(A) Group 20% TCM + PBM: Application of chemical peel of 20% trichloroacetic acid solution in association with photobiomodulation with red spectrum LED (660nm) on the back of the hands.
(B) Group 20% TCM + PBM placebo: Application of chemical peel of 20% trichloroacetic acid solution in association with simulated photobiomodulation on the back of the hands.
It is observed that all participants included in the study will receive treatment recommended for photoaging on the back of the hands. The chemical peel (20% TCM solution) will be performed monthly, totaling 04 sessions with an average time of 40 minutes (guidelines, photos, skin exfoliation) with intervals of 04 weeks between applications. Biweekly assessments (guidelines and photos) will be carried out with an average time of 20 minutes during the study period. In addition, a group will also be subjected to photobiomodulation with 660nm LED during the sessions for the analysis of the association of therapies and comparison with exfoliation monotherapy.
It is noteworthy that both hands will be treated and control will be maintained in another randomized and uniform group, with no possibility of ethical compromise of different therapies with asymmetric results in the participants. Another important benefit provided by the separation of the control group will be the impossibility of light to influence the non-irradiated tissue. This case would occur if the hand subjected to photobiomodulation plus exfoliation was in the same individual as the hand subjected to exfoliation monotherapy. This influence is defended by countless scientists who research on the systemic effects of phototherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Group A: 20% TCM and PBM
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.
Intervention: 20% TCM and PBM (Combination Product)
Group B: 20% TCM and PBM placebo
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.
Intervention: 20% TCM and PBM placebo (Other)
Outcomes
Primary Outcomes
Fine wrinkles
Time Frame: 6 months
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.
Secondary Outcomes
- Abnormal pigmentation(6 months)
- Scale of Satisfaction(6 months)
- Visual Analog Scale (VAS) for pain(6 months)
- Coarse wrinkles(6 months)
- Global evaluation(6 months)
Investigators
Anna Carolina Ratto Tempestini Horliana
Co-supervisor
University of Nove de Julho