Stretch Marks, Striae, Treatment
Conditions
Keywords
Stretch marks, Striae, Tretinoin, Superficial dermabrasion
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.
Interventions
DRUGTretinoin 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.
DEVICESuperficial Dermabrasion
Group 2 will receive 16 sessions of dermabrasion that would be held in the research center
Sponsors
Hexsel Dermatology Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
11 Years to 25 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Width of Stretch Marks | Baseline and 16 weeks | Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) |
| Length of Stretch Marks | Baseline and 16 weeks | Striae length was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Aesthetic Improvement Scale | 16 weeks | 1. Very much improved: Optimal cosmetic result for the implant in this patient 2. 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 | 16 weeks | Patient satisfaction measured with Lickert scale (Very satisfied, Satisfied, Neither satisfied nor unsatisfied, unsatisfied, very unsatisfied) |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 10 |
| Superficial Dermabrasion 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 | 12 |
| Total | 22 |
Baseline characteristics
| Characteristic | Tretinoin | Superficial Dermabrasion | Total |
|---|---|---|---|
| Age, Continuous | 16.7 years STANDARD_DEVIATION 4.3 | 17.0 years STANDARD_DEVIATION 3.2 | 16.9 years STANDARD_DEVIATION 3.6 |
| Body mass index | 23.7 kg/m^2 STANDARD_DEVIATION 4.4 | 24.8 kg/m^2 STANDARD_DEVIATION 3.3 | 24.3 kg/m^2 STANDARD_DEVIATION 3.8 |
| Fitzpatrick skin phototype Fitzpatrick skin phototype I | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick skin phototype Fitzpatrick skin phototype II | 4 Participants | 5 Participants | 9 Participants |
| Fitzpatrick skin phototype Fitzpatrick skin phototype III | 5 Participants | 6 Participants | 11 Participants |
| Fitzpatrick skin phototype Fitzpatrick skin phototype IV | 1 Participants | 1 Participants | 2 Participants |
| Fitzpatrick skin phototype Fitzpatrick skin phototype V | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick skin phototype Fitzpatrick skin phototype VI | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Brazil | 10 Participants | 12 Participants | 22 Participants |
| Sex: Female, Male Female | 10 Participants | 12 Participants | 22 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 12 |
| other Total, other adverse events | 7 / 10 | 7 / 12 |
| serious Total, serious adverse events | 0 / 10 | 0 / 12 |
Outcome results
Primary
Length of Stretch Marks
Striae length was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
Time frame: Baseline and 16 weeks
Population: Per protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tretinoin | Length of Stretch Marks | Baseline | 1.371 centimeters | Standard Deviation 0.631 |
| Tretinoin | Length of Stretch Marks | Week 16 | 0.894 centimeters | Standard Deviation 0.457 |
| Superficial Dermabrasion | Length of Stretch Marks | Baseline | 1.518 centimeters | Standard Deviation 0.386 |
| Superficial Dermabrasion | Length of Stretch Marks | Week 16 | 1.111 centimeters | Standard Deviation 0.673 |
Primary
Width of Stretch Marks
Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
Time frame: Baseline and 16 weeks
Population: Per protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tretinoin | Width of Stretch Marks | Baseline | 0.199 centimeters | Standard Deviation 0.129 |
| Tretinoin | Width of Stretch Marks | Week 16 | 0.088 centimeters | Standard Deviation 0.073 |
| Superficial Dermabrasion | Width of Stretch Marks | Baseline | 0.146 centimeters | Standard Deviation 0.052 |
| Superficial Dermabrasion | Width of Stretch Marks | Week 16 | 0.077 centimeters | Standard Deviation 0.04 |
Secondary
Global Aesthetic Improvement Scale
1. Very much improved: Optimal cosmetic result for the implant in this patient 2. 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
Population: Per protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tretinoin | Global Aesthetic Improvement Scale | Very much improved | 3 Participants |
| Tretinoin | Global Aesthetic Improvement Scale | Much improved | 5 Participants |
| Tretinoin | Global Aesthetic Improvement Scale | Improved | 2 Participants |
| Superficial Dermabrasion | Global Aesthetic Improvement Scale | Very much improved | 1 Participants |
| Superficial Dermabrasion | Global Aesthetic Improvement Scale | Much improved | 5 Participants |
| Superficial Dermabrasion | Global Aesthetic Improvement Scale | Improved | 6 Participants |
Secondary
Patient Satisfaction
Patient satisfaction measured with Lickert scale (Very satisfied, Satisfied, Neither satisfied nor unsatisfied, unsatisfied, very unsatisfied)
Time frame: 16 weeks
Population: Per protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tretinoin | Patient Satisfaction | Very satisfied | 1 Participants |
| Tretinoin | Patient Satisfaction | Satisfied | 4 Participants |
| Tretinoin | Patient Satisfaction | Neither satisfied nor unsatisfied | 1 Participants |
| Superficial Dermabrasion | Patient Satisfaction | Very satisfied | 6 Participants |
| Superficial Dermabrasion | Patient Satisfaction | Satisfied | 4 Participants |
| Superficial Dermabrasion | Patient Satisfaction | Neither satisfied nor unsatisfied | 2 Participants |