Comparative Effects Of Trichloroacetic Chemical Peel And Fractional Laser

NCT07036302 | Enrolling By Invitation DMC

• 1 other identifier: CAAE 84943324.1.0000.5501
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Melasma; Acne Scars - Mixed Atrophic and Hypertrophic; Resurfacing; Rejuvenation

Keywords

chemical peel; Er-YAG; ND-YAG; fractional laser; home care

Outcome Measures

Primary Outcomes (3)

• Glogau scale

  Changes in Glogau scale (I to IV) for rejuvenation group. Higher values indicate worse aging conditions.

  Baseline versus 3 months

• Melasma index

  Changes in 1 to 6 scores of modified Melasma Area and Severity Index (mMASI). Higher values indicate worse melasma conditions.

  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.

  Baseline versus 3 months after treatment

Secondary Outcomes (3)

• Treatment impact on Quality of life

  Baseline versus immediate post-treatment

• Patient's satisfaction

  Immediate post-treatment

• Professional's satisfaction

  3 months after treatment

Other Outcomes (2)

• Self-reported pain

  Days 0, 30 and 60.

• Adverse Events

  Baseline versus 12 months after treatment

Study Arms (9)

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

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

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

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

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

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

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

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

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

Radiation: Erbium-YAG laser

Interventions

35% TCA combined with croton oil peel PROCEDURE

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

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 peel PROCEDURE

3 sections every 30 days of isolate 35% TCA peel

Acne scars isolate TCA peel; Facial rejuvenation isolate 35% TCA peel; Melasma isolate TCA peel

Erbium-YAG laser RADIATION

3 sections every 30 days of Er-YAG laser

Acne scars Er-YAG laser; Facial wrinkles Er-YAG laser

Neodymium -YAG laser Q-switched RADIATION

3 sections every 30 days of ND-YAG laser

Melasma Laser ND-YAG laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jose Roberto Cortelli: lead
• Cavalca & Cortelli private research center: collaborator

Study Sites (2)

Cavalca & Cortelli Research Center

Taubaté, São Paulo, 12010-700, Brazil

Location

University of Taubate Dental School

Taubaté, São Paulo, 12020-330, Brazil

Location

MeSH Terms

Conditions

Melanosis; Hypertrophy

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Sheila C Cortelli, Doctorate

  University of Taubate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistics staff
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Doctorate

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: June 25, 2025
• Study Start: June 2, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)