N/A
N=30
Fractional Laser and Ultrasound for Striae Distensae
Stretch Marks
Bottom Line
View on ClinicalTrials.gov: NCT01186848 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Live-rater by Two Blinded Dermatologists — 77.27; 22.73 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Combination treatment (Device); 1550-nm erbium-doped fractionated laser (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Live-rater by Two Blinded Dermatologists |
77.27; 22.73 | — |
Summary
This was a prospective randomized controlled study comparing the efficacy of micro-focused ultrasound when used in conjunction with 1550-nm erbium-doped fractionated laser versus 1550-nm erbium-doped fractionated laser alone for treatment of striae distensae(stretch marks).
Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side.
The primary outcome measure by two dermatologists blindly compared the two areas of striae distensae on each side from live subjects using a questionnaire and quartile rating scale on the final follow-up visit.
This study was a pilot study designed to determine the feasibility of these procedures.
Eligibility Criteria
Inclusion Criteria
- Age 18-60 years old male and female subjects with striae distensae on both thighs or both sides of the abdomen.
- Subjects are in good health.
- Subjects are willing, have the ability to understand and provide informed consent, and are able to communicate with the investigator.
- Subjects should be within a 20 lb range of their starting weight during in the study period.
Exclusion Criteria
- Pregnant or lactating
- Subjects who are unable to understand the protocol or give informed consent.
- Subjects currently under treatment with corticosteroids for any medical problems or subjects who discontinued treatment less than 2 months prior to consent.
- Subjects who have had medical e.g usage of oral or topical retinoids, laser or surgical treatment for striae distensae within the last year.
- Subjects who have active skin disease or skin infection in the treatment area.
- Subjects who are allergic to lidocaine or prilocaine.
- Subjects who have a history of abnormal scarring.
Data sourced from ClinicalTrials.gov (NCT01186848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.