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Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks

Primary Purpose

Stretch Marks, Striae, Treatment

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Tretinoin cream 0.005%
Superficial Dermabrasion
Sponsored by
Brazilan Center for Studies in Dermatology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stretch Marks focused on measuring Stretch marks, Striae, Tretinoin, Superficial dermabrasion

Eligibility Criteria

11 Years - 25 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Brazilian Center for Studies in Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tretinoin

Superficial Dermabrasion

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Width of Stretch Marks
Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
Length of Stretch Marks
Striae length was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)

Secondary Outcome Measures

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

Full Information

First Posted
December 8, 2009
Last Updated
January 4, 2021
Sponsor
Brazilan Center for Studies in Dermatology
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1. Study Identification

Unique Protocol Identification Number
NCT01027793
Brief Title
Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks
Official Title
Randomized Clinical Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Recent Stretch Marks
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brazilan Center for Studies in Dermatology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stretch Marks, Striae, Treatment
Keywords
Stretch marks, Striae, Tretinoin, Superficial dermabrasion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tretinoin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Superficial Dermabrasion
Arm Type
Active Comparator
Arm Description
Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.
Intervention Type
Drug
Intervention Name(s)
Tretinoin cream 0.005%
Other Intervention Name(s)
(Vitanol A, Stiefel)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Superficial Dermabrasion
Intervention Description
Group 2 will receive 16 sessions of dermabrasion that would be held in the research center
Primary Outcome Measure Information:
Title
Width of Stretch Marks
Description
Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
Time Frame
Baseline and 16 weeks
Title
Length of Stretch Marks
Description
Striae length was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
Time Frame
Baseline and 16 weeks
Secondary Outcome Measure Information:
Title
Global Aesthetic Improvement Scale
Description
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
Time Frame
16 weeks
Title
Patient Satisfaction
Description
Patient satisfaction measured with Lickert scale (Very satisfied, Satisfied, Neither satisfied nor unsatisfied, unsatisfied, very unsatisfied)
Time Frame
16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doris M Hexsel, MD
Organizational Affiliation
Brazilian Center For Studies in Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brazilian Center for Studies in Dermatology
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90570 040
Country
Brazil

12. IPD Sharing Statement

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Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks

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