An interventional study of Combination treatment and 1550-nm erbium-doped fractionated laser in Stretch Marks, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-03.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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.
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.
39 studies on the registry are indexed under Striae Distensae; 6 are open to participants now.
This study's enrollment of 30 is close to the median of 28 across 38 interventional studies indexed under Striae Distensae.
Browse Striae Distensae studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: 1550-nm erbium-doped fractionated laser
"micro-focused ultrasound" and "1550nm-fractionated laser"
Device: Combination 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.
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.
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
Recruitment period took place over approximately 6 months at an urban academic hospital.
| Milestone | Subjects Receiving Split Body Treatment |
|---|---|
| Started | 30 |
| Completed | 22 |
| Not completed | 8 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Adverse event | 2 |
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".
| Percentage of participants | 1550-nm Erbium-doped Fractionated Laser | Combination Treatment |
|---|---|---|
| Live-rater by Two Blinded Dermatologists | 77.27 (54.63 to 92.18) | 22.73 (7.82 to 45.37) |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1550-nm Erbium-doped Fractionated Laser | — | 0/30 (0%) | 1/30 (3.3%) |
| Combination Treatment | — | 0/30 (0%) | 3/30 (10%) |
| Event | 1550-nm Erbium-doped Fractionated Laser | Combination Treatment |
|---|---|---|
| painGeneral disorders | 0/30 | 1/30 |
| numbnessGeneral disorders | 0/30 | 1/30 |
| hyperpigmentationGeneral disorders | 1/30 | 1/30 |
| Age, Categorical(Participants) | Subjects Receiving Split Body Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 30 |
| >=65 years | 0 |
| Age, Continuous(years) | Subjects Receiving Split Body Treatment |
|---|---|
| Mean | 36 ± 8.2 |
| Sex: Female, Male(Participants) | Subjects Receiving Split Body Treatment |
|---|---|
| Female | 28 |
| Male | 2 |
| Region of Enrollment(participants) | Subjects Receiving Split Body Treatment |
|---|---|
| United States | 30 |
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Northwestern University