Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks - Full Text View

Sponsor:	Brazilan Center for Studies in Dermatology
Information provided by:	Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier:	NCT01027793

Purpose

This study aims to evaluate head-to-head the effectiveness of tretinoin 0.5% and superficial dermabrasion in subjects that have recent stretch marks.

Condition	Intervention	Phase
Stretch Marks Striae Treatment	Drug: Tretinoin cream 0.005% Device: Superficial Dermabrasion	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Clinical Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Recent Stretch Marks

Resource links provided by NLM:

Drug Information available for: Tretinoin

U.S. FDA Resources

Further study details as provided by Brazilan Center for Studies in Dermatology:

Primary Outcome Measures:

Global Aesthetic Improvement Scale - Investigator [ Time Frame: 18 week ] [ Designated as safety issue: No ]
Global Aesthetic Improvement Scale - Independent Dermatologist [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Width of stretch marks [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Length of stretch marks [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Level of satisfaction [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	March 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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.	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. Other Name: (Vitanol A, Stiefel)
Active Comparator: Superficial Dermabrasion Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.	Device: Superficial Dermabrasion Group 2 will receive 16 sessions of dermabrasion that would be held in the research center

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.

Eligibility

Ages Eligible for Study:	11 Years to 25 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027793

Locations

Brazil
Brazilian Center for Studies in Dermatology
Porto Alegre, Rio Grande do Sul, Brazil, 90570 040

Sponsors and Collaborators

Brazilan Center for Studies in Dermatology

Investigators

Principal Investigator:

Doris M Hexsel, MD

Brazilian Center For Studies in Dermatology

More Information

No publications provided

Responsible Party:	Doris Hexsel, Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier:	NCT01027793 History of Changes
Other Study ID Numbers:	11-CBED08-01
Study First Received:	December 8, 2009
Last Updated:	July 6, 2010
Health Authority:	Brazil: Ministry of Health; Brazil: National Committee of Ethics in Research

Keywords provided by Brazilan Center for Studies in Dermatology:

Stretch marks
Striae
Tretinoin
Superficial dermabrasion

Additional relevant MeSH terms:

Striae Distensae
Skin Manifestations
Signs and Symptoms
Tretinoin
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on February 09, 2012