跳至主要内容
临床试验/NCT07036302
NCT07036302进行中(未招募)不适用

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

Jose Roberto Cortelli4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年6月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
120
试验地点
4
主要终点
Glogau scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Statistics staff

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

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

干预措施: 35% TCA combined with croton oil peel (Procedure)

Acne scars Er-YAG laser

Active Comparator

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

干预措施: Erbium-YAG laser (Radiation)

Melasma isolate TCA peel

Active Comparator

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

干预措施: Isolate 35% TCA peel (Procedure)

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

干预措施: 35% TCA combined with croton oil peel (Procedure)

Facial rejuvenation isolate 35% TCA peel

Active Comparator

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

干预措施: Isolate 35% TCA peel (Procedure)

Melasma Laser ND-YAG laser

Active Comparator

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

干预措施: Neodymium -YAG laser Q-switched (Radiation)

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

干预措施: 35% TCA combined with croton oil peel (Procedure)

Acne scars isolate TCA peel

Active Comparator

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

干预措施: Isolate 35% TCA peel (Procedure)

Facial wrinkles Er-YAG laser

Active Comparator

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

干预措施: Erbium-YAG laser (Radiation)

结局指标

主要结局

Glogau scale

时间窗: Baseline, 3 and 6 months

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

Glogau scale

时间窗: Baseline versus 3 months

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

Melasma index

时间窗: 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

时间窗: 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.

次要结局

  • Treatment impact on Quality of life(Baseline versus immediate post-treatment)
  • Patient's satisfaction(Immediate post-treatment)
  • Professional's satisfaction(3 months after treatment)

研究者

发起方
Jose Roberto Cortelli
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jose Roberto Cortelli

Professor and Doctorate

University of Taubate

研究点 (4)

Loading locations...

相似试验