Effectivity of 1 Finger Tip Unit Compared to 2 Finger Tip Units 0.05% Tretinoin Cream Before and After 30% Trichloroacetic Acid Chemical Peeling on Aging Skin
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change of Subjective Pain Evaluation
研究概览
简要总结
This clinical study will compare the efficacy of using one fingertip unit and two fingertip units of 0.05% before and after 30% trichloroacetic acid chemical peel procedure for facial skin rejuvenation in 35-60 years old female patients with Glogau II-III skin classification.
详细描述
This study is an experimental study with a randomized controlled trial (RCT) design on patients who met the inclusion criteria. Group A will receive pretreatment in the form of 0.05% tretinoin cream which is used as much as one fingertip unit every night, and group B will receive the same cream which should be used as much as two fingertip units. This cream will be used for two weeks before the patients receive a chemical peeling therapy using 30% trichloroacetic acid. The results of therapy will mainly be assessed based on the Dermoscopic Photoaging Scale (DPAS), as well as visual analog scale (VAS) for subjective symptoms and Clinician Erythema Assessment Scale (CEA) for erythema.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients aged 35-60 years old
- •Patients with Glogau II-III skin classification
- •Patients are willing to participate in the study and sign an informed consent form
排除标准
- •Patients with hypertrophic scars or keloid on the face
- •Patients with open wound or infection on the face
- •History of other topical treatment on the face within 1 month of enrollment
- •Pregnant or breastfeeding mother
- •Patients and/or their families are not willing to participate in the study.
研究组 & 干预措施
1 Fingertip Unit 0.05% Tretinoin
Subjects were randomized to receive the instructions to use 1 fingertip unit of 0.05% tretinoin cream for 2 weeks before the first chemical peeling. After that, this therapy is instructed to be used for 4 weeks after the chemical peeling procedure with 30% trichloroacetic acid until the scheduled evaluation.
干预措施: 0.05% Tretinoin (Drug)
2 Fingertip Units 0.05% Tretinoin
Subjects were randomized to receive the instructions to use 2 fingertip units of 0.05% tretinoin cream for 2 weeks before the first chemical peeling. After that, this therapy is instructed to be used for 4 weeks after the chemical peeling procedure with 30% trichloroacetic acid until the scheduled evaluation.
干预措施: 0.05% Tretinoin (Drug)
结局指标
主要结局
Change of Subjective Pain Evaluation
时间窗: Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure
using Visual Analog Scale (VAS). Scale range is 0-10, 0 indicates no pain and 10 indicates severe pain
Change in Skin Thickness
时间窗: Baseline(pre-chemical peeling procedure) and 4 weeks after chemical peeling procedure
Evaluation with USG of epidermal and dermal layer (in pixels)
Change of Photoaged Skin Condition
时间窗: Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure
using dermoscopic photoaging scale (DPAS). This DPAS assessment is based on yes or no rules on 11 criteria in four facial regions, namely left malar, right malar, forehead, and chin. The criteria were yellowish discoloration, white line, lentigo, hypo- and hyper-pigmented macules, telangiectasia, yellow papules, actinic keratosis, senile comedones, deep wrinkle, superficial wrinkle, and criss-cross wrinkle. Score range is 0-44 points.
Change of Erythema Degree
时间窗: Baseline(pre-chemical peeling procedure), immediately after chemical peeling procedure, and 4 weeks after chemical peeling procedure
using Clinician Erythema Assessment Scale (CEA). Scale range is 0-4, 0 indicates no erythema and 4 indicates severe erythema
次要结局
未报告次要终点
研究者
Dr.dr.Irma Bernadette, SpKK (K)
Irma Bernadette S. Sitohang, MD, PhD - Head of Cosmetic Dermatology Division, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Indonesia University