Trial Outcomes & Findings for Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks (NCT NCT01027793)
NCT ID: NCT01027793
Last Updated: 2021-01-22
Results Overview
Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
Baseline and 16 weeks
Results posted on
2021-01-22
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
15
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks
Baseline characteristics by cohort
| Measure |
Tretinoin
n=10 Participants
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.
|
Superficial Dermabrasion
n=12 Participants
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
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.7 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
17.0 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
16.9 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Fitzpatrick skin phototype
Fitzpatrick skin phototype I
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Fitzpatrick skin phototype
Fitzpatrick skin phototype II
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Fitzpatrick skin phototype
Fitzpatrick skin phototype III
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Fitzpatrick skin phototype
Fitzpatrick skin phototype IV
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Fitzpatrick skin phototype
Fitzpatrick skin phototype V
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Fitzpatrick skin phototype
Fitzpatrick skin phototype VI
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body mass index
|
23.7 kg/m^2
STANDARD_DEVIATION 4.4 • n=5 Participants
|
24.8 kg/m^2
STANDARD_DEVIATION 3.3 • n=7 Participants
|
24.3 kg/m^2
STANDARD_DEVIATION 3.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 16 weeksPopulation: Per protocol.
Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
Outcome measures
| Measure |
Tretinoin
n=10 Participants
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.
|
Superficial Dermabrasion
n=12 Participants
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
|
|---|---|---|
|
Width of Stretch Marks
Baseline
|
0.199 centimeters
Standard Deviation 0.129
|
0.146 centimeters
Standard Deviation 0.052
|
|
Width of Stretch Marks
Week 16
|
0.088 centimeters
Standard Deviation 0.073
|
0.077 centimeters
Standard Deviation 0.040
|
PRIMARY outcome
Timeframe: Baseline and 16 weeksPopulation: Per protocol.
Striae length was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
Outcome measures
| Measure |
Tretinoin
n=10 Participants
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.
|
Superficial Dermabrasion
n=12 Participants
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
|
|---|---|---|
|
Length of Stretch Marks
Baseline
|
1.371 centimeters
Standard Deviation 0.631
|
1.518 centimeters
Standard Deviation 0.386
|
|
Length of Stretch Marks
Week 16
|
0.894 centimeters
Standard Deviation 0.457
|
1.111 centimeters
Standard Deviation 0.673
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Per protocol.
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
Outcome measures
| Measure |
Tretinoin
n=10 Participants
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.
|
Superficial Dermabrasion
n=12 Participants
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
|
|---|---|---|
|
Global Aesthetic Improvement Scale
Very much improved
|
3 Participants
|
1 Participants
|
|
Global Aesthetic Improvement Scale
Much improved
|
5 Participants
|
5 Participants
|
|
Global Aesthetic Improvement Scale
Improved
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Per protocol.
Patient satisfaction measured with Lickert scale (Very satisfied, Satisfied, Neither satisfied nor unsatisfied, unsatisfied, very unsatisfied)
Outcome measures
| Measure |
Tretinoin
n=10 Participants
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.
|
Superficial Dermabrasion
n=12 Participants
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
|
|---|---|---|
|
Patient Satisfaction
Very satisfied
|
1 Participants
|
6 Participants
|
|
Patient Satisfaction
Satisfied
|
4 Participants
|
4 Participants
|
|
Patient Satisfaction
Neither satisfied nor unsatisfied
|
1 Participants
|
2 Participants
|
Adverse Events
Tretinoin
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Superficial Dermabrasion
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tretinoin
n=10 participants at risk
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.
|
Superficial Dermabrasion
n=12 participants at risk
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
60.0%
6/10
|
41.7%
5/12
|
|
Skin and subcutaneous tissue disorders
Erythema
|
60.0%
6/10
|
33.3%
4/12
|
|
Skin and subcutaneous tissue disorders
Scaling
|
40.0%
4/10
|
16.7%
2/12
|
|
Skin and subcutaneous tissue disorders
Stinging
|
20.0%
2/10
|
33.3%
4/12
|
Additional Information
Dr. Doris Hexsel
Brazilian Center for Studies in Dermatology
Phone: +55 51 30262633
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place