Randomized Clinical Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Recent Stretch Marks
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Width of Stretch Marks
研究概览
简要总结
This study aims to evaluate head-to-head the effectiveness of tretinoin 0.5% and superficial dermabrasion in subjects that have recent stretch marks.
详细描述
Healthy female subjects, from 11 t0 25 years old, that have thin (1-5mm) recent(less than 6 months of evolution),reddish or purple line stretch marks. The striae should be symmetrical and it could be located in the abdomen,breasts, upper arms, thighs (both inner and outer), hips, and buttocks.
Thirty subjects will be randomly divided in two groups:
Group 1 will receive tretinoin cream that should be applied daily in areas affected by stretch marks.
Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.
Subjects will be evaluated by pictures, measurement of width and length of stretch marks, using Mirror System(Canfield).
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
- None
入排标准
- 年龄范围
- 11 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects, aged between 11 and 25 years
- •Female subjects of childbearing age that present a negative urine pregnancy test and are using an effective contraceptive method for at least 3 months prior the study
- •Subjects that have thin (1-5mm) recent(less than 6 months of evolution),reddish or purple line stretch marks. The striae should be symmetrical and it could be located in the abdomen,breasts, upper arms, thighs (both inner and outer), hips, and buttocks
- •Subjects agreeing to take part of the study, after being fully informed of the purpose and the nature of the investigation and after having signed the informed consent form
- •Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol
- •Subjects who had never received treatment for striae in the studied area
排除标准
- •Subjects whose medical history and physical examination present clinical pathology, as marfan Syndrome, cushing, systemic autoimmune or neurological diseases
- •Pregnant or women in breastfeeding, or women planning to become pregnant
- •Previous treatment for striae in the local area of the study.
- •Subjects that are in use of tretinoin or glycolic acid in the local area of the study.
- •Presence of white striae in the local area of the study
- •History of Connective Tissue Disease
- •History of keloid development or skin healing problems
- •Subjects that are taking medications associated with striae development, as systemic corticosteroids, indinavir, hormonal replacement therapy
- •Hypersensibility to retinoic acid
- •Subjects who intend to get tan in the area of the study, through exposure of sun or tanning machines during the study
- •Subjects that have a variation in their weight of more than 2 kg in a period of four months prior the study
- •Predisposition for chronic inflammatory process
- •Subjects with chronic diseases as diabetes, cardiopathy, neoplasm, HIV and autoimmune diseases (vitiligo, lupus)
研究组 & 干预措施
Tretinoin
Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.
干预措施: Tretinoin cream 0.005% (Drug)
Superficial Dermabrasion
Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.
干预措施: Superficial Dermabrasion (Device)
结局指标
主要结局
Width of Stretch Marks
时间窗: Baseline and 16 weeks
Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
Length of Stretch Marks
时间窗: Baseline and 16 weeks
Striae length was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
次要结局
- Global Aesthetic Improvement Scale(16 weeks)
- Patient Satisfaction(16 weeks)
研究者
Doris Hexsel
MD
Brazilan Center for Studies in Dermatology