Phase 4
N=32
Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks
Stretch Marks · Striae · Treatment
Bottom Line
View on ClinicalTrials.gov: NCT01027793 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Width of Stretch Marks — 0.199; 0.146; 0.088; 0.077 centimeters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tretinoin cream 0.005% (Drug); Superficial Dermabrasion (Device)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- Female
- Sponsor
- Hexsel Dermatology Clinic
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Width of Stretch Marks |
0.199; 0.146; 0.088; 0.077 | — |
| PRIMARY Length of Stretch Marks |
1.371; 1.518; 0.894; 1.111 | — |
| SECONDARY Global Aesthetic Improvement Scale |
3; 1; 5; 5; 2; 6 | — |
| SECONDARY Patient Satisfaction |
1; 6; 4; 4; 1; 2 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT01027793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.