Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks

Study Overview
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Brief Summary
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This study aims to evaluate head-to-head the effectiveness of tretinoin 0.5% and superficial dermabrasion in subjects that have recent stretch marks.

Detailed Description
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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). Biopsy to quantify alterations of epidermis and dermis of treated area, will be held pre-treatment and 2 weeks after the conclusion of treatment. For biopsy will be used a punch of 3mm. The results will be evaluated two weeks after the conclusion of the interventions. An independent dermatologist, blinded for intervention, will analyse pictures pre and post treatment. This subjective evaluation will be performed using Global Aesthetic Improvement Scale. Safety and adverse events will be assessed each visit.

Official Title
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Randomized Clinical Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Recent Stretch Marks

Conditions
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Stretch Marks, Striae, Treatment

Intervention / Treatment
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* Drug: Tretinoin cream 0.005%
* Device: Superficial Dermabrasion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tretinoin<br>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. | Drug: Tretinoin cream 0.005%<br>* 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.<br>* Other names: (Vitanol A, Stiefel);|
| Active Comparator: Superficial Dermabrasion<br>Group 2 will receive 16 sessions of dermabrasion that would be held in the research center. | Device: Superficial Dermabrasion<br>* Group 2 will receive 16 sessions of dermabrasion that would be held in the research center<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Width of Stretch Marks | Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) | Baseline and 16 weeks | 
| Length of Stretch Marks | Striae length was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) | Baseline and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Aesthetic Improvement Scale | Very much improved: Optimal cosmetic result for the implant in this patient Much improved: Marked improvement in appearance from the initial condition but not completely optimal for this patient; touch-up would slightly improve the result 3 - Improved: Obvious improvement in appearance from the initial condition, but touch-up or retreatment is indicated 4 - No change: Appearance essentially the same as the original condition 5 - Worse: Appearance worse than the original condition | 16 weeks | 
| Patient Satisfaction | Patient satisfaction measured with Lickert scale (Very satisfied, Satisfied, Neither satisfied nor unsatisfied, unsatisfied, very unsatisfied) | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stretch marks, Striae, Tretinoin, Superficial dermabrasion