- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04485091
TCA Peel and Photobiomodulation for Hand Rejuvenation
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
In addition, both groups will prepare the skin properly before the treatments in order to enhance the effects of the exfoliation, allow the uniform penetration of the chemical solution in the back of the hands, decrease the healing time after the procedure and significantly reduce the risks of major complications such as post-inflammatory hyperpigmentation. Throughout the period, the participants will also be instructed on the importance of photoprotection with the daily use of factor 30 sunscreen. If there is a patient with severe hypersensitivity or major complications, the intervention will be discontinued immediately and properly treated according to its severity.
It should be noted that regardless of the results obtained at the end of the research, even if photobiomodulation improves or accelerates the benefits of chemical peeling, participants will not be submitted to new treatment sessions, as both groups will already receive treatment recommended for photoaging of hands. Furthermore, the application of photobiomodulation without the association of previous skin exfoliation is unlikely to bring better results, because early application after tissue injury is the most important factor for this purpose.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Marcos Momolli
- Phone Number: +5511994383855
- Email: marcosmomolli10@gmail.com
Study Locations
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-
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São Paulo, Brazil, 01504-001
- University of Nove de Julho (UNINOVE)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Placebo Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coarse 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.
|
6 months
|
Abnormal pigmentation
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.
|
6 months
|
Global evaluation
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.
|
6 months
|
Visual Analog Scale (VAS) for pain
Time Frame: 6 months
|
The visual analog scale has been used to measure intangible quantities such as pain, quality of life and anxiety, since the 1920s.
Measuring the subjective experience of pain is a continuous challenge in medicine, and VAS, despite its limitations, is a primary outcome measure validated for pain intensity.
Participants will use the scale to measure pain intensity during the study during biweekly medical evaluations.
The number 0 means the total absence of pain complaints, while the number 10 is equivalent to the greatest pain ever experienced by the participant.
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6 months
|
Scale of Satisfaction
Time Frame: 6 months
|
Monthly, participants will be evaluated at the specialty clinic to analyze the results provided by the study.
The individuals will answer a questionnaire composed by a 5-point Likert scale modified by the author about the satisfaction of the obtained results
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6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marcos Momolli, University of Nove de Julho
Publications and helpful links
General Publications
- Ishida-Yamamoto A, Kartasova T, Matsuo S, Kuroki T, Iizuka H. Involucrin and SPRR are synthesized sequentially in differentiating cultured epidermal cells. J Invest Dermatol. 1997 Jan;108(1):12-6. doi: 10.1111/1523-1747.ep12285611.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PHOTOACID
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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