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NCT Number: NCT07036302

Comparative Effects Of Trichloroacetic Chemical Peel And Fractional Laser

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cavalca & Cortelli Research Center, Taubaté, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

35% TCA combined with croton oil peel

Procedure

3 sections every 30 days of 35% TCA combined with croton oil peel

Isolate 35% TCA peel

Procedure

3 sections every 30 days of isolate 35% TCA peel

Erbium-YAG laser

Radiation

3 sections every 30 days of Er-YAG laser

Neodymium -YAG laser Q-switched

Radiation

3 sections every 30 days of ND-YAG laser

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Treatment impact on Quality of life

    Time frame: Baseline versus immediate post-treatment

    SKINDEX-16 scores (0 to 100) after treatment. Higher values indicate worse quality of life.

  2. Patient's satisfaction

    Time frame: Immediate post-treatment

    Evaluation of Patient Global Assessment (PtGA) instrument. Results are expressed into quartile percentages. The most higher percentages indicates the best patient's satisfaction.

  3. Professional's satisfaction

    Time frame: 3 months after treatment

    Evaluation of Physician Global Assessment (PGA) instrument. Results are expressed into quartile percentages. The most higher percentages indicates the best professional's satisfaction.

Other outcomes

  1. Self-reported pain

    Time frame: Days 0, 30 and 60.

    Evaluation by a 10 point Visual Analogue Scale. Higher values indicate worse pain experience.

  2. Adverse Events

    Time frame: Baseline versus 12 months after treatment

    Self-reported and diagnosed adverse events

  3. LINE-1

    Time frame: baseline vs. 6 months

    Changes in DNA methylation (5-meC), hydroxymethylation (5-hmeC) and 5-meC/5-hmeC ratio in the promoter region of LINE-1 elements

Sponsors and collaborators

Lead sponsor

Jose Roberto Cortelli

Other

Collaborators

  • Cavalca & Cortelli private research center

Registry information

Official study title

Clinical Evaluation of Trichloroacetic Chemical Peel And Fractional Laser: Comparative Analysis Of Quantitative And Qualitative Parameters

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 25, 2025
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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