Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks

Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027793
• Other study ID #: 11-CBED08-01
• Status: Completed
• Phase: Phase 4
• Start date: March 2009
• Est. completion date: August 2010

Study information

• Verified date: January 2021
• Source: Brazilan Center for Studies in Dermatology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 11 Years to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Stretch Marks
• Striae
• Striae Distensae
• Treatment

Intervention

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.

Device:
• Superficial Dermabrasion
Group 2 will receive 16 sessions of dermabrasion that would be held in the research center

Locations

Country	Name	City	State
Brazil	Brazilian Center for Studies in Dermatology	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Brazilan Center for Studies in Dermatology

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Width of Stretch Marks	Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)	Baseline and 16 weeks
Primary	Length of Stretch Marks	Striae length was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)	Baseline and 16 weeks
Secondary	Global Aesthetic Improvement Scale	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	16 weeks
Secondary	Patient Satisfaction	Patient satisfaction measured with Lickert scale (Very satisfied, Satisfied, Neither satisfied nor unsatisfied, unsatisfied, very unsatisfied)	16 weeks