Clinical Evaluation of Trichloroacetic Chemical Peel And Fractional Laser: Comparative Analysis Of Quantitative And Qualitative Parameters
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
- 否
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
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
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
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
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
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
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
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
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
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
Jose Roberto Cortelli
Professor and Doctorate
University of Taubate
