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Completed

NCT Number: NCT01027793

Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for 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.

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Key information

Age range

11 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Brazilian Center for Studies in Dermatology

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: (Vitanol A, Stiefel)

Superficial Dermabrasion

Device

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

Primary outcomes

  1. Width of Stretch Marks

    Time frame: Baseline and 16 weeks

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

  2. Length of Stretch Marks

    Time frame: Baseline and 16 weeks

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

Secondary outcomes

  1. Global Aesthetic Improvement Scale

    Time frame: 16 weeks

    • Very much improved: Optimal cosmetic result for the implant in this patient
    • 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
  2. Patient Satisfaction

    Time frame: 16 weeks

    Patient satisfaction measured with Lickert scale (Very satisfied, Satisfied, Neither satisfied nor unsatisfied, unsatisfied, very unsatisfied)

Sponsors and collaborators

Lead sponsor

Hexsel Dermatology Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 9, 2009
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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