Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brazilan Center for Studies in Dermatology
• Treatments: Tretinoin

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)