Trial Outcomes & Findings for Fractional Laser and Ultrasound for Striae Distensae (NCT NCT01186848)

Results Overview

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".

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

week 10

Results posted on

2021-12-03

Participant Flow

Recruitment period took place over approximately 6 months at an urban academic hospital.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	30
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	2
Overall Study Adverse Event	2

Baseline Characteristics

Fractional Laser and Ultrasound for Striae Distensae

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Receiving Split Body Treatment n=30 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	36 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure	1550-nm Erbium-doped Fractionated Laser n=22 Participants 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.	Combination Treatment n=22 Participants 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.
Live-rater by Two Blinded Dermatologists	77.27 Percentage of participants Interval 54.63 to 92.18	22.73 Percentage of participants Interval 7.82 to 45.37

Adverse Events

1550-nm Erbium-doped Fractionated Laser

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Combination Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	1550-nm Erbium-doped Fractionated Laser n=30 participants at risk 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.	Combination Treatment n=30 participants at risk 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.
General disorders pain	0.00% 0/30	3.3% 1/30 • Number of events 1
General disorders numbness	0.00% 0/30	3.3% 1/30 • Number of events 1
General disorders hyperpigmentation	3.3% 1/30 • Number of events 1	3.3% 1/30 • Number of events 1

Additional Information

Dr. Murad Alam

Northwestern University

Phone: 312-695-4761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place