MelasmaNCT07036302
Comparative Effects Of Trichloroacetic Chemical Peel And Fractional Laser
A study testing 35% TCA combined with croton oil peel, Isolate 35% TCA peel and Erbium-YAG laser in people with Melasma and Acne Scars - Mixed Atrophic and Hypertrophic, run by Jose Roberto Cortelli at 2 sites in Brazil.
Trial summary
More than aesthetics, the search for orofacial harmonization treatments has increased when the negative emotional impact of some facial conditions such as melasma and acne scars is recognized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melasma, Acne Scars - Mixed Atrophic and Hypertrophic, Resurfacing
- What is being tested?
- 35% TCA combined with croton oil peel, Isolate 35% TCA peel and Erbium-YAG laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesBrazil
- Study dates
- 2 Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women
- aged 18 or over
- acne scars, melasma or clear signs of photoaging and evident wrinkles
- participants with acne scars or melasma will be included if they have never undergone treatment or if previous treatment has been ineffective.
Who cannot join
- phototype VI
- autoimmune and dermatological diseases
- known allergies to the components of the formulations
- patients who prefer other treatment options
- history of keloids
- pregnant women
- breastfeeding women
- women of childbearing age who do not adopt a valid method of contraception
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Cavalca & Cortelli Research Center
Taubaté, São Paulo, 12010-700
University of Taubate Dental School
Taubaté, São Paulo, 12020-330
About this study
Official title: Clinical Evaluation of Trichloroacetic Chemical Peel And Fractional Laser: Comparative Analysis Of Quantitative And Qualitative Parameters
More than aesthetics, the search for orofacial harmonization treatments has increased when the negative emotional impact of some facial conditions such as melasma and acne scars is recognized. This study will evaluate the effects of chemical peels with 35% TCA (trichloroacetic acid) and two types of fractional laser in orofacial harmonization procedures. A sample of 100-120 participants at least 18 years of age, male or female, with complaints of melasma (n=36 to 40), acne scars (n=36 to 40) or facial wrinkles (n=36 to 40) will be recruited to underwent 3 consecutive treatment sections every 30 days. Besides clinical improvements, global satisfaction scale of the professional and the patient will be measured in addition to the impact of the treatment on the quality of life of the participants and the sensory experience in relation to pain. Pre- and pos-peeling home care will be provided to measure whether they influence results or not. The aim of this study is to identify the most appropriate treatment strategy for frequent complaints in clinical practice, and among them, the one that promotes the best experience, with the shortest recovery time and is cost-effective.
Read the detailed description
More than aesthetics, the search for orofacial harmonization treatments has increased when the negative emotional impact of some facial conditions such as melasma and acne scars is recognized. This randomized clinical trial will evaluate the effects of chemical peel with 35% TCA (trichloroacetic acid)associated with croton oil. And to compare the results with its isolated formulation containing only 35% TCA and with two types of fractional laser (2940nm Er-YAG and 1640nm Nd-YAG) in orofacial harmonization procedures. This study will be based on a sample of 100-120 participants at least 18 years of age, male or female, with complaints of melasma (n=36 to 40), acne scars (n=36 to 40) or facial wrinkles (n=36 to 40). The experimental times will be day -15 (pre-treatment), day 0 (1st treatment session), day 30 (2nd treatment session), day 60 (3rd treatment session), day 70 (immediate post-treatment) and day 120 (mediate post-treatment). The primary outcomes will be the difference (pre- versus post-peeling) in the scores of Melasma (mMASI), acne scars (SCAR-S) or facial wrinkles (Glogau index), in the respective groups according to the main complaints. As secondary outcomes, the global satisfaction scale of the professional (PGA) and the patient (PtGA) will be measured; the impact of the treatment on the quality of life of the participants (SKINDEX-16) and the sensory experience in relation to pain (EVA 1 to 10). All participants, under local anesthesia (button anesthesia), will be randomized into one of three treatment groups: 35% TCA associated with croton oil (test), 35% TCA alone, Er-Yag or Nd-YAG laser (comparators). Intra- and inter-group differences will be considered statistically significant when p < 0.05. The aim of this study is to identify the most appropriate treatment strategy for frequent complaints in clinical practice, and among them, the one that promotes the best experience, with the shortest recovery time and is cost-effective.
- Being tested
- 35% TCA combined with croton oil peel, Isolate 35% TCA peel, Erbium-YAG laser, Neodymium -YAG laser Q-switched
- Keywords
- chemical peel, Er-YAG, ND-YAG, fractional laser, home care
- Medical subject headings
- Melanosis, Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
35% TCA combined with croton oil peelProcedure or surgery
3 sections every 30 days of 35% TCA combined with croton oil peel
Isolate 35% TCA peelProcedure or surgery
3 sections every 30 days of isolate 35% TCA peel
Erbium-YAG laserRadiation
3 sections every 30 days of Er-YAG laser
Neodymium -YAG laser Q-switchedRadiation
3 sections every 30 days of ND-YAG laser
| Study group | Role | What they receive |
|---|---|---|
| Melasma TCA associated with croton oil peel | Experimental | 3 sections every 30 days of a chemical peel combining 35% TCA and croton oil in the same formulation Receives: Procedure: 35% TCA combined with croton oil peel |
| Melasma isolate TCA peel | Active comparator | 3 sections every 30 days of a chemical peel containing only 35% TCA Receives: Procedure: Isolate 35% TCA peel |
| Melasma Laser ND-YAG laser | Active comparator | 3 sections every 30 days of Neodymium: yttrium-aluminum-garnet (ND-YAG) laser Receives: Radiation: Neodymium -YAG laser Q-switched |
| Acne scars TCA associated with croton oil peel | Experimental | 3 sections every 30 days of a chemical peel combining 35% TCA and croton oil in the same formulation Receives: Procedure: 35% TCA combined with croton oil peel |
| Acne scars isolate TCA peel | Active comparator | 3 sections every 30 days of a chemical peel containing only 35% TCA Receives: Procedure: Isolate 35% TCA peel |
| Acne scars Er-YAG laser | Active comparator | 3 sections every 30 days of Erbium: yttrium-aluminum-garnet (Er-YAG) laser Receives: Radiation: Erbium-YAG laser |
| Facial rejuvenation TCA associated with croton oil peel | Experimental | 3 sections every 30 days of a chemical peel combining 35% TCA and croton oil in the same formulation Receives: Procedure: 35% TCA combined with croton oil peel |
| Facial rejuvenation isolate 35% TCA peel | Active comparator | 3 sections every 30 days of a chemical peel containing only 35% TCA Receives: Procedure: Isolate 35% TCA peel |
| Facial wrinkles Er-YAG laser | Active comparator | 3 sections every 30 days of Erbium: yttrium-aluminum-garnet (Er-YAG) laser Receives: Radiation: Erbium-YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glogau scale
Changes in Glogau scale (I to IV) for rejuvenation group. Higher values indicate worse aging conditions.
Measured: Baseline, 3 and 6 months
Melasma index
Changes in 1 to 6 scores of modified Melasma Area and Severity Index (mMASI). Higher values indicate worse melasma conditions.
Measured: baseline versus 3 months after treatment
Acne Scars Index
Changes in Global 1 to 5 Scale for Acne Scar Severity (SCAR-S). Higher values indicate worse acne scars conditions.
Measured: Baseline versus 3 months after treatment
Secondary outcomes (3)
Treatment impact on Quality of life
SKINDEX-16 scores (0 to 100) after treatment. Higher values indicate worse quality of life.
Measured: Baseline versus immediate post-treatment
Patient's satisfaction
Evaluation of Patient Global Assessment (PtGA) instrument. Results are expressed into quartile percentages. The most higher percentages indicates the best patient's satisfaction.
Measured: Immediate post-treatment
Professional's satisfaction
Evaluation of Physician Global Assessment (PGA) instrument. Results are expressed into quartile percentages. The most higher percentages indicates the best professional's satisfaction.
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start2 Jun 2025
- Primary completion2 Dec 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jose Roberto Cortelli
- Sponsor type
- University, hospital or other
- Collaborators
- Cavalca & Cortelli private research center
- Responsible party
- Sponsor-investigator, Jose Roberto Cortelli, University of Taubate
- Investigators
- Sheila C Cortelli, Doctorate, Principal investigator, University of Taubate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036302
- Sponsor's protocol ID
- CAAE 84943324.1.0000.5501
- Status last verified
- May 2026
- First submitted
- 15 Jun 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only not identified data will be shared within research team.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Trichloroacetic Chemical Peel And Fractional Laser: Comparative Analysis Of Quantitative And Qualitative Parameters
- ClinicalTrials.gov ID
- NCT07036302
- Acronym / sponsor ID
- CAAE 84943324.1.0000.5501
- Keywords
- chemical peel, Er-YAG, ND-YAG, fractional laser, home care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jose Roberto CortelliUniversity, hospital or other
- Collaborators
- Cavalca & Cortelli private research center
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Jun 2025 (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.
More than aesthetics, the search for orofacial harmonization treatments has increased when the negative emotional impact of some facial conditions such as melasma and acne scars is recognized. This study will evaluate the effects of chemical peels with 35% TCA (trichloroacetic acid) and two types of fractional laser in orofacial harmonization procedures. A sample of 100-120 participants at least 18 years of age, male or female, with complaints of melasma (n=36 to 40), acne scars (n=36 to 40) or facial wrinkles (n=36 to 40) will be recruited to underwent 3 consecutive treatment sections every 30 days. Besides clinical improvements, global satisfaction scale of the professional and the patient will be measured in addition to the impact of the treatment on the quality of life of the participants and the sensory experience in relation to pain. Pre- and pos-peeling home care will be provided to measure whether they influence results or not. The aim of this study is to identify the most appropriate treatment strategy for frequent complaints in clinical practice, and among them, the one that promotes the best experience, with the shortest recovery time and is cost-effective.
Detailed description
More than aesthetics, the search for orofacial harmonization treatments has increased when the negative emotional impact of some facial conditions such as melasma and acne scars is recognized. This randomized clinical trial will evaluate the effects of chemical peel with 35% TCA (trichloroacetic acid)associated with croton oil. And to compare the results with its isolated formulation containing only 35% TCA and with two types of fractional laser (2940nm Er-YAG and 1640nm Nd-YAG) in orofacial harmonization procedures. This study will be based on a sample of 100-120 participants at least 18 years of age, male or female, with complaints of melasma (n=36 to 40), acne scars (n=36 to 40) or facial wrinkles (n=36 to 40). The experimental times will be day -15 (pre-treatment), day 0 (1st treatment session), day 30 (2nd treatment session), day 60 (3rd treatment session), day 70 (immediate post-treatment) and day 120 (mediate post-treatment). The primary outcomes will be the difference (pre- versus post-peeling) in the scores of Melasma (mMASI), acne scars (SCAR-S) or facial wrinkles (Glogau index), in the respective groups according to the main complaints. As secondary outcomes, the global satisfaction scale of the professional (PGA) and the patient (PtGA) will be measured; the impact of the treatment on the quality of life of the participants (SKINDEX-16) and the sensory experience in relation to pain (EVA 1 to 10). All participants, under local anesthesia (button anesthesia), will be randomized into one of three treatment groups: 35% TCA associated with croton oil (test), 35% TCA alone, Er-Yag or Nd-YAG laser (comparators). Intra- and inter-group differences will be considered statistically significant when p < 0.05. The aim of this study is to identify the most appropriate treatment strategy for frequent complaints in clinical practice, and among them, the one that promotes the best experience, with the shortest recovery time and is cost-effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Melasma TCA associated with croton oil peel | Experimental | Procedure: 35% TCA combined with croton oil peel3 sections every 30 days of a chemical peel combining 35% TCA and croton oil in the same formulation |
| Melasma isolate TCA peel | Active comparator | Procedure: Isolate 35% TCA peel3 sections every 30 days of a chemical peel containing only 35% TCA |
| Melasma Laser ND-YAG laser | Active comparator | Radiation: Neodymium -YAG laser Q-switched3 sections every 30 days of Neodymium: yttrium-aluminum-garnet (ND-YAG) laser |
| Acne scars TCA associated with croton oil peel | Experimental | Procedure: 35% TCA combined with croton oil peel3 sections every 30 days of a chemical peel combining 35% TCA and croton oil in the same formulation |
| Acne scars isolate TCA peel | Active comparator | Procedure: Isolate 35% TCA peel3 sections every 30 days of a chemical peel containing only 35% TCA |
| Acne scars Er-YAG laser | Active comparator | Radiation: Erbium-YAG laser3 sections every 30 days of Erbium: yttrium-aluminum-garnet (Er-YAG) laser |
| Facial rejuvenation TCA associated with croton oil peel | Experimental | Procedure: 35% TCA combined with croton oil peel3 sections every 30 days of a chemical peel combining 35% TCA and croton oil in the same formulation |
| Facial rejuvenation isolate 35% TCA peel | Active comparator | Procedure: Isolate 35% TCA peel3 sections every 30 days of a chemical peel containing only 35% TCA |
| Facial wrinkles Er-YAG laser | Active comparator | Radiation: Erbium-YAG laser3 sections every 30 days of Erbium: yttrium-aluminum-garnet (Er-YAG) laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women
- aged 18 or over
- acne scars, melasma or clear signs of photoaging and evident wrinkles
- participants with acne scars or melasma will be included if they have never undergone treatment or if previous treatment has been ineffective.
Key exclusion criteria (8 listed)
- phototype VI
- autoimmune and dermatological diseases
- known allergies to the components of the formulations
- patients who prefer other treatment options
- history of keloids
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 |
|---|---|---|
| 35% TCA combined with croton oil peel3 sections every 30 days of 35% TCA combined with croton oil peel | Procedure or surgery | Acne scars TCA associated with croton oil peel, Facial rejuvenation TCA associated with croton oil peel, Melasma TCA associated with croton oil peel |
| Isolate 35% TCA peel3 sections every 30 days of isolate 35% TCA peel | Procedure or surgery | Acne scars isolate TCA peel, Facial rejuvenation isolate 35% TCA peel, Melasma isolate TCA peel |
| Erbium-YAG laser3 sections every 30 days of Er-YAG laser | Radiation | Acne scars Er-YAG laser, Facial wrinkles Er-YAG laser |
| Neodymium -YAG laser Q-switched3 sections every 30 days of ND-YAG laser | Radiation | Melasma Laser ND-YAG laser |
Primary outcome
Glogau scale
Time frame: Baseline, 3 and 6 months
Changes in Glogau scale (I to IV) for rejuvenation group. Higher values indicate worse aging conditions.
Melasma index
Time frame: baseline versus 3 months after treatment
Changes in 1 to 6 scores of modified Melasma Area and Severity Index (mMASI). Higher values indicate worse melasma conditions.
Acne Scars Index
Time frame: Baseline versus 3 months after treatment
Changes in Global 1 to 5 Scale for Acne Scar Severity (SCAR-S). Higher values indicate worse acne scars conditions.
3 secondary outcomes
Treatment impact on Quality of life
Time frame: Baseline versus immediate post-treatment
Patient's satisfaction
Time frame: Immediate post-treatment
Professional's satisfaction
Time frame: 3 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No. Only not identified data will be shared within research team.
Related trials for Melasma
Enrolling by invitationPhase 4
Microneedling-Assisted Metformin, Tranexamic Acid, and Modified Kligman's Formula for Melasma
Melasma (Facial Melasma)
Active, not recruitingPhase 4
Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma in the Treatment of Moderate-to-Severe Melasma: A Randomized Comparative Study
Melasma (Facial Melasma)
Not yet recruiting
COMPARISON OF TOPICAL VITAMIN C VS NIACINAMIDE IN TREATMENT OF MELASMA
Melasma
Not yet recruiting
New Treatment in Melasma
Female, With
Not yet recruitingPhase 4
Baseline Dermoscopic Vascular Score and Response to Oral Tranexamic Acid in Facial Melasma
Melasma
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.
Sheila C Cortelli, Doctorate principal investigator
University of Taubate
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 35% TCA combined with croton oil peel, Isolate 35% TCA peel and Erbium-YAG laser in people with Melasma and Acne Scars - Mixed Atrophic and Hypertrophic, run by Jose Roberto Cortelli at 2 sites 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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Glogau scale (time frame: Baseline, 3 and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2026.