Brazilian Center for Studies in Dermatology
Porto Alegre, Rio Grande do Sul, 90570 040, Brazil
NCT Number: NCT01027793
This study aims to evaluate head-to-head the effectiveness of tretinoin 0.5% and superficial dermabrasion in subjects that have recent stretch marks.
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Notify Me11 year–25 year
Female
Interventional
Phase 4
Porto Alegre, Rio Grande do Sul, 90570 040, Brazil
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: (Vitanol A, Stiefel)
Group 2 will receive 16 sessions of dermabrasion that would be held in the research center
Time frame: Baseline and 16 weeks
Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
Time frame: Baseline and 16 weeks
Striae length was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
Time frame: 16 weeks
Time frame: 16 weeks
Patient satisfaction measured with Lickert scale (Very satisfied, Satisfied, Neither satisfied nor unsatisfied, unsatisfied, very unsatisfied)
Hexsel Dermatology Clinic
Other
Randomized Clinical Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Recent Stretch Marks
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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