Skin AgingPhase 2NCT04485091
TCA Peel and Photobiomodulation for Hand Rejuvenation
A Phase 2 study testing 20% TCM and PBM in people with Skin Aging, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Skin Aging
- What is being tested?
- 20% TCM and PBM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2021to 28 Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Skin Aging
- Being tested
- 20% TCM and PBM, 20% TCM and PBM placebo
- Keywords
- Photoaging, Photodamage, Chemical peel, Photobiomodulation, Phototherapy, Skin rejuvenation, Rejuvenation of hands, low-level laser therapy (LLLT), light emitting diode (LED)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20% TCM and PBMCombination 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.
20% TCM and PBM placeboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: 20% TCM and PBM placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
Coarse 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.
Measured: 6 months
Abnormal pigmentation
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.
Measured: 6 months
Global evaluation
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.
Measured: 6 months
Visual Analog Scale (VAS) for pain
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.
Measured: 6 months
Scale of Satisfaction
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Oct 2021
- Primary completion31 Jan 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho
- Investigators
- Marcos Momolli, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485091
- Sponsor's protocol ID
- PHOTOACID
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2020
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 8980279Zhang 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.
PubMed 29692196Blanpain 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.
PubMed 16824012Soleymani 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.
PubMed 30214663Lindley 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.
PubMed 27556760Yaar 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.
PubMed 17711532Avci 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.
PubMed 24049929McKenzie 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.
PubMed 21242389
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04485091
- Acronym / sponsor ID
- PHOTOACID
- Conditions
- Skin Aging
- Keywords
- Photoaging, Photodamage, Chemical peel, Photobiomodulation, Phototherapy, Skin rejuvenation, Rejuvenation of hands, low-level laser therapy (LLLT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: 20% TCM and PBM | Experimental | Combination Product: 20% TCM and PBM21 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. |
| Group B: 20% TCM and PBM placebo | Placebo comparator | Other: 20% TCM and PBM placebo21 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20% TCM and PBMThe 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. | Combination product | Group A: 20% TCM and PBM |
| 20% TCM and PBM placeboThe 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. | Other | Group B: 20% TCM and PBM placebo |
Primary outcome
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.
5 secondary outcomes
Coarse wrinkles
Time frame: 6 months
Abnormal pigmentation
Time frame: 6 months
Global evaluation
Time frame: 6 months
Visual Analog Scale (VAS) for pain
Time frame: 6 months
Scale of Satisfaction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 8980279Ishida-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.
- Background: PubMed 29692196Zhang 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.
- Background: PubMed 16824012Blanpain 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.
- Background: PubMed 30214663Soleymani 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.
- Background: PubMed 27556760Lindley 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.
- Background: PubMed 17711532Yaar 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.
- Background: PubMed 24049929Avci 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.
- Results publication: PubMed 21242389McKenzie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcos Momolli principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 20% TCM and PBM in people with Skin Aging, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fine wrinkles (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04485091, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.