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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1550-nm erbium-doped fractionated laser | Active Comparator |
| |
| Combination treatment | Active Comparator | "micro-focused ultrasound" and "1550nm-fractionated laser" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination treatment | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | week 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Department of Dermatology | Chicago | Illinois | 60611 | United States |
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Recruitment period took place over approximately 6 months at an urban academic hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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". | Posted | Number | 95% Confidence Interval | Percentage of participants | week 10 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1550-nm Erbium-doped Fractionated Laser | 1550-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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Murad Alam | Northwestern University | 312-695-4761 | m-alam@northwestern.edu |
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| ID | Term |
|---|---|
| D057896 | Striae Distensae |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 1550-nm erbium-doped fractionated laser | Device | 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. |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Combination Treatment |
Combination of micro-focused ultrasound and 1550nm-fractionated laser : The treated sites were 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. |
|
|
| 0 |
| 30 |
| 1 |
| 30 |
| EG001 | Combination Treatment | Combination of micro-focused ultrasound and 1550nm-fractionated laser : The treated sites were 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. | 0 | 30 | 3 | 30 |
| numbness | General disorders |
|
| hyperpigmentation | General disorders |
|
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