Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks

NCT01027793 | Completed Phase 4 Results

• 1 other identifier: 11-CBED08-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stretch Marks; Striae; Treatment

Keywords

Stretch marks; Striae; Tretinoin; Superficial dermabrasion

Outcome Measures

Primary Outcomes (2)

• Width of Stretch Marks

  Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)

  Baseline and 16 weeks

• Length of Stretch Marks

  Striae length was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)

  Baseline and 16 weeks

Secondary Outcomes (2)

• Global Aesthetic Improvement Scale

  16 weeks

• Patient Satisfaction

  16 weeks

Study Arms (2)

Tretinoin

ACTIVE COMPARATOR

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.

Drug: Tretinoin cream 0.005%

Superficial Dermabrasion

ACTIVE COMPARATOR

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

Device: Superficial Dermabrasion

Interventions

Tretinoin cream 0.005% 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.

Also known as: (Vitanol A, Stiefel)

Tretinoin

Superficial Dermabrasion DEVICE

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

Superficial Dermabrasion

Eligibility Criteria

• Age: 11 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hexsel Dermatology Clinic: lead

Study Sites (1)

Brazilian Center for Studies in Dermatology

Porto Alegre, Rio Grande do Sul, 90570 040, Brazil

Location

MeSH Terms

Conditions

Striae Distensae

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Doris Hexsel
• Organization: Brazilian Center for Studies in Dermatology

cientifico@cbed.org.br

+55 51 30262633

Study Officials

• Doris M Hexsel, MD

  Brazilian Center For Studies in Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 8, 2009
• First Posted: December 9, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: January 22, 2021
• Results First Posted: January 22, 2021

Record last verified: 2021-01

Locations

BR (1)