NCT01027793

Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Hexsel Dermatology Clinic · Academic / Other
• Sex: Female
• Age: 11 Years – 25 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Stretch Marks
• Striae
• Treatment

Interventions

Type	Name	Description
DRUG	Tretinoin cream 0.005%	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.
DEVICE	Superficial Dermabrasion	Group 2 will receive 16 sessions of dermabrasion that would be held in the research center

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-12-09
• Last updated: 2021-01-22
• Results posted: 2021-01-22

Locations

1 site across 1 country: Brazil