Fractional Laser and Ultrasound for Striae Distensae

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01186848
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stretch Marks	Device: Combination treatment; Device: 1550-nm erbium-doped fractionated laser	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Fractional Photothermolysis Alone Versus Fractional Photothermolysis Plus Intense Focused Ultrasound for Treatment of Striae Distensae: A Prospective Randomized Control Trial.
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1550-nm erbium-doped fractionated laser	Device: 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.
Active Comparator: Combination treatment "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.

Outcome Measures

Primary Outcome Measures

1. 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".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Department of Dermatology	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Murad Alam, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery and Surgery-Organ Transplantation, Northwestern University
• ClinicalTrials.gov Identifier: NCT01186848
• Other Study ID Numbers: STU34376
• First Posted: Aug 23, 2010
• Last Update Posted: Dec 3, 2021
• Last Verified: Dec 1, 2021

• Keywords provided by Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery and Surgery-Organ Transplantation, Northwestern University: Stretch marks; Striae distensae
• Additional relevant MeSH terms: Striae Distensae

Study Results

Participant Flow

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

Arm/Group Title	Subjects Receiving Split Body Treatment
Arm/Group Description	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.
Period Title: Overall Study
STARTED	30
COMPLETED	22
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Subjects Receiving Split Body Treatment
Arm/Group Description	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 Participants	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	30 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36 (8.2)
Sex: Female, Male (Count of Participants)
Female	28 93.3%
Male	2 6.7%
Region of Enrollment (participants) [Number]
United States	30 100%

Outcome Measures

1. Primary Outcome

Title	Live-rater by Two Blinded Dermatologists
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1550-nm Erbium-doped Fractionated Laser	Combination Treatment
Arm/Group Description	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 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.
Measure Participants	22	22
Number (95% Confidence Interval) [Percentage of participants]	77.27 257.6%	22.73 NaN

Adverse Events

Arm/Group Title	1550-nm Erbium-doped Fractionated Laser		Combination Treatment
Arm/Group Description	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 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.
All Cause Mortality
	1550-nm Erbium-doped Fractionated Laser		Combination Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	1550-nm Erbium-doped Fractionated Laser		Combination Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	1550-nm Erbium-doped Fractionated Laser		Combination Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/30 (3.3%)		3/30 (10%)
General disorders
pain	0/30 (0%)	0	1/30 (3.3%)	1
numbness	0/30 (0%)	0	1/30 (3.3%)	1
hyperpigmentation	1/30 (3.3%)	1	1/30 (3.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.