Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks

NCT ID: NCT01027793

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tretinoin

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 Type: ACTIVE_COMPARATOR

Tretinoin cream 0.005%

Intervention Type: DRUG

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.

Superficial Dermabrasion

Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.

Group Type: ACTIVE_COMPARATOR

Superficial Dermabrasion

Intervention Type: DEVICE

Group 2 will receive 16 sessions of dermabrasion that would be held in the research center

Interventions

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.

Intervention Type: DRUG

Superficial Dermabrasion

Group 2 will receive 16 sessions of dermabrasion that would be held in the research center

Intervention Type: DEVICE

Other Intervention Names

(Vitanol A, Stiefel)

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)

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Brazilan Center for Studies in Dermatology

OTHER

Sponsor Role: lead

Responsible Party

Doris Hexsel

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doris M Hexsel, MD

Role: PRINCIPAL_INVESTIGATOR

Brazilian Center For Studies in Dermatology

Locations

Brazilian Center for Studies in Dermatology

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

11-CBED08-01

Identifier Type: -

Identifier Source: org_study_id