Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks

• Sponsor: Brazilan Center for Studies in Dermatology (Other)
• Overall Status: Completed
• CT.gov ID: NCT01027793
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stretch Marks; Striae; Treatment	Drug: Tretinoin cream 0.005%; Device: Superficial Dermabrasion	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Clinical Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Recent Stretch Marks
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Width of Stretch Marks [Baseline and 16 weeks]

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

2. Length of Stretch Marks [Baseline and 16 weeks]

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

Secondary Outcome Measures

1. Global Aesthetic Improvement Scale [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 [16 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Years to 25 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brazilian Center for Studies in Dermatology	Porto Alegre	Rio Grande Do Sul	Brazil	90570 040

Sponsors and Collaborators

• Brazilan Center for Studies in Dermatology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Doris Hexsel, MD, Brazilan Center for Studies in Dermatology
• ClinicalTrials.gov Identifier: NCT01027793
• Other Study ID Numbers: 11-CBED08-01
• First Posted: Dec 9, 2009
• Last Update Posted: Jan 22, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by Doris Hexsel, MD, Brazilan Center for Studies in Dermatology: Stretch marks; Striae; Tretinoin; Superficial dermabrasion
• Additional relevant MeSH terms: Striae Distensae; Tretinoin

Study Results

Participant Flow

Arm/Group Title	Tretinoin	Superficial Dermabrasion
Arm/Group 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. 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.	Group 2 will receive 16 sessions of dermabrasion that would be held in the research center. Superficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center
Period Title: Overall Study
STARTED	17	15
COMPLETED	10	12
NOT COMPLETED	7	3

Baseline Characteristics

Arm/Group Title	Tretinoin	Superficial Dermabrasion	Total
Arm/Group 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. 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.	Group 2 will receive 16 sessions of dermabrasion that would be held in the research center. Superficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center	Total of all reporting groups
Overall Participants	10	12	22
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	16.7 (4.3)	17.0 (3.2)	16.9 (3.6)
Sex: Female, Male (Count of Participants)
Female	10 100%	12 100%	22 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Brazil	10 100%	12 100%	22 100%
Fitzpatrick skin phototype (Count of Participants)
Fitzpatrick skin phototype I	0 0%	0 0%	0 0%
Fitzpatrick skin phototype II	4 40%	5 41.7%	9 40.9%
Fitzpatrick skin phototype III	5 50%	6 50%	11 50%
Fitzpatrick skin phototype IV	1 10%	1 8.3%	2 9.1%
Fitzpatrick skin phototype V	0 0%	0 0%	0 0%
Fitzpatrick skin phototype VI	0 0%	0 0%	0 0%
Body mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	23.7 (4.4)	24.8 (3.3)	24.3 (3.8)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Per protocol.

Arm/Group Title	Tretinoin	Superficial Dermabrasion
Arm/Group 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. 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.	Group 2 will receive 16 sessions of dermabrasion that would be held in the research center. Superficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center
Measure Participants	10	12
Baseline	0.199 (0.129)	0.146 (0.052)
Week 16	0.088 (0.073)	0.077 (0.040)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Per protocol.

Arm/Group Title	Tretinoin	Superficial Dermabrasion
Arm/Group 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. 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.	Group 2 will receive 16 sessions of dermabrasion that would be held in the research center. Superficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center
Measure Participants	10	12
Baseline	1.371 (0.631)	1.518 (0.386)
Week 16	0.894 (0.457)	1.111 (0.673)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Per protocol.

Arm/Group Title	Tretinoin	Superficial Dermabrasion
Arm/Group 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. 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.	Group 2 will receive 16 sessions of dermabrasion that would be held in the research center. Superficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center
Measure Participants	10	12
Very much improved	3 30%	1 8.3%
Much improved	5 50%	5 41.7%
Improved	2 20%	6 50%

4. Secondary Outcome

Title	Patient Satisfaction
Description	Patient satisfaction measured with Lickert scale (Very satisfied, Satisfied, Neither satisfied nor unsatisfied, unsatisfied, very unsatisfied)
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Per protocol.

Arm/Group Title	Tretinoin	Superficial Dermabrasion
Arm/Group 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. 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.	Group 2 will receive 16 sessions of dermabrasion that would be held in the research center. Superficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center
Measure Participants	10	12
Very satisfied	1 10%	6 50%
Satisfied	4 40%	4 33.3%
Neither satisfied nor unsatisfied	1 10%	2 16.7%

Adverse Events

Arm/Group Title	Tretinoin		Superficial Dermabrasion
Arm/Group 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. 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.		Group 2 will receive 16 sessions of dermabrasion that would be held in the research center. Superficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center
All Cause Mortality
	Tretinoin		Superficial Dermabrasion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/12 (0%)
Serious Adverse Events
	Tretinoin		Superficial Dermabrasion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Tretinoin		Superficial Dermabrasion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/10 (70%)		7/12 (58.3%)
Skin and subcutaneous tissue disorders
Pruritus	6/10 (60%)		5/12 (41.7%)
Erythema	6/10 (60%)		4/12 (33.3%)
Scaling	4/10 (40%)		2/12 (16.7%)
Stinging	2/10 (20%)		4/12 (33.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.