Stretch Marks
Conditions
Keywords
Stretch marks, Striae distensae
Brief 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.
Detailed description
The secondary outcomes were qualitative measurements of the mean striae width in the treatment area before(week0) and after treatment(week10) and subject satisfaction was determined by a satisfaction questionnaire.
Interventions
DEVICECombination treatment
The contralateral side received the combination of 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.
DEVICE1550-nm erbium-doped fractionated laser
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.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live-rater by Two Blinded Dermatologists | week 10 | The primary outcome was a blinded rating of the treatment area (Fractional Laser vs. Fractional Laser plus Intense Focused Ultrasound) with the best cosmetic appearance. Two dermatologists blindly evaluated the treated and control areas of each side from live subjects on the final follow up visit (week 10). This was reported as percentages of participants for whom 1550-nm Erbium-doped Fractionated Laser or Micro-focused Ultrasound and 1550nm-fractionated Laser resulted in the best cosmetic appearance. |
Countries
United States
Participant flow
Recruitment details
Recruitment period took place over approximately 6 months at an urban academic hospital.
Participants by arm
| Arm | Count |
|---|---|
| Subjects Receiving Split Body Treatment The unit of randomization was the individual side of a body within each subject to receive either 1550-nm erbium-doped fractionated laser treatment or the combination of the laser and ultrasound treatment for the treatment of striae.
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. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Subjects Receiving Split Body Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 36 years STANDARD_DEVIATION 8.2 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 30 | 3 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Live-rater by Two Blinded Dermatologists
The primary outcome was a blinded rating of the treatment area (Fractional Laser vs. Fractional Laser plus Intense Focused Ultrasound) with the best cosmetic appearance. Two dermatologists blindly evaluated the treated and control areas of each side from live subjects on the final follow up visit (week 10). This was reported as percentages of participants for whom 1550-nm Erbium-doped Fractionated Laser or Micro-focused Ultrasound and 1550nm-fractionated Laser resulted in the best cosmetic appearance.
Time frame: week 10
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1550-nm Erbium-doped Fractionated Laser | Live-rater by Two Blinded Dermatologists | 77.27 Percentage of participants |
| Combination Treatment | Live-rater by Two Blinded Dermatologists | 22.73 Percentage of participants |