Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT07036302
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-25
First Post:
2025-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Effects Of Trichloroacetic Chemical Peel And Fractional Laser
Sponsor:
Jose Roberto Cortelli
Organization:
Study Overview
Official Title:
Clinical Evaluation of Trichloroacetic Chemical Peel And Fractional Laser: Comparative Analysis Of Quantitative And Qualitative Parameters
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: