Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks
Condition: Stretch Marks; Striae; Treatment
MeSH terms: Striae Distensae
Intervention: Tretinoin cream 0.005%; Superficial Dermabrasion
Intervention description: 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.; Group 2 will receive 16 sessions of dermabrasion that would be held in the research center
Intervention MeSH terms: Tretinoin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: Female
Minimum age: 11 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Stretch marks; Striae; Tretinoin; Superficial dermabrasion

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.
    

Eligibility criteria:

        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)