Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks

January 4, 2021 updated by: Doris Hexsel, Brazilan Center for Studies in Dermatology

Randomized Clinical Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Recent Stretch Marks

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90570 040
        • Brazilian Center For Studies in Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • (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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Width of Stretch Marks
Time Frame: Baseline and 16 weeks
Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
Baseline and 16 weeks
Length of Stretch Marks
Time Frame: Baseline and 16 weeks
Striae length was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
Baseline and 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Aesthetic Improvement Scale
Time Frame: 16 weeks
  1. Very much improved: Optimal cosmetic result for the implant in this patient
  2. Much improved: Marked improvement in appearance from the initial condition but not completely optimal for this patient; touch-up would slightly improve the result 3 - Improved: Obvious improvement in appearance from the initial condition, but touch-up or retreatment is indicated 4 - No change: Appearance essentially the same as the original condition 5 - Worse: Appearance worse than the original condition
16 weeks
Patient Satisfaction
Time Frame: 16 weeks
Patient satisfaction measured with Lickert scale (Very satisfied, Satisfied, Neither satisfied nor unsatisfied, unsatisfied, very unsatisfied)
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brazilan Center for Studies in Dermatology

Investigators

  • Principal Investigator: Doris M Hexsel, MD, Brazilian Center For Studies in Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

December 8, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 4, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-CBED08-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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