Comparative Effects Of Trichloroacetic Chemical Peel And Fractional Laser

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-02

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Melasma Acne Scars - Mixed Atrophic and Hypertrophic Resurfacing Rejuvenation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Statistics staff

Study Groups

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Melasma TCA associated with croton oil peel

3 sections every 30 days of a chemical peel combining 35% TCA and croton oil in the same formulation

Group Type EXPERIMENTAL

35% TCA combined with croton oil peel

Intervention Type PROCEDURE

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

Melasma isolate TCA peel

3 sections every 30 days of a chemical peel containing only 35% TCA

Group Type ACTIVE_COMPARATOR

Isolate 35% TCA peel

Intervention Type PROCEDURE

3 sections every 30 days of isolate 35% TCA peel

Melasma Laser ND-YAG laser

3 sections every 30 days of Neodymium: yttrium-aluminum-garnet (ND-YAG) laser

Group Type ACTIVE_COMPARATOR

Neodymium -YAG laser Q-switched

Intervention Type RADIATION

3 sections every 30 days of ND-YAG laser

Acne scars TCA associated with croton oil peel

3 sections every 30 days of a chemical peel combining 35% TCA and croton oil in the same formulation

Group Type EXPERIMENTAL

35% TCA combined with croton oil peel

Intervention Type PROCEDURE

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

Acne scars isolate TCA peel

3 sections every 30 days of a chemical peel containing only 35% TCA

Group Type ACTIVE_COMPARATOR

Isolate 35% TCA peel

Intervention Type PROCEDURE

3 sections every 30 days of isolate 35% TCA peel

Acne scars Er-YAG laser

3 sections every 30 days of Erbium: yttrium-aluminum-garnet (Er-YAG) laser

Group Type ACTIVE_COMPARATOR

Erbium-YAG laser

Intervention Type RADIATION

3 sections every 30 days of Er-YAG laser

Facial rejuvenation TCA associated with croton oil peel

3 sections every 30 days of a chemical peel combining 35% TCA and croton oil in the same formulation

Group Type EXPERIMENTAL

35% TCA combined with croton oil peel

Intervention Type PROCEDURE

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

Facial rejuvenation isolate 35% TCA peel

3 sections every 30 days of a chemical peel containing only 35% TCA

Group Type ACTIVE_COMPARATOR

Isolate 35% TCA peel

Intervention Type PROCEDURE

3 sections every 30 days of isolate 35% TCA peel

Facial wrinkles Er-YAG laser

3 sections every 30 days of Erbium: yttrium-aluminum-garnet (Er-YAG) laser

Group Type ACTIVE_COMPARATOR

Erbium-YAG laser

Intervention Type RADIATION

3 sections every 30 days of Er-YAG laser

Interventions

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35% TCA combined with croton oil peel

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

Intervention Type PROCEDURE

Isolate 35% TCA peel

3 sections every 30 days of isolate 35% TCA peel

Intervention Type PROCEDURE

Erbium-YAG laser

3 sections every 30 days of Er-YAG laser

Intervention Type RADIATION

Neodymium -YAG laser Q-switched

3 sections every 30 days of ND-YAG laser

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No