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Fractional Laser and Ultrasound for Striae Distensae

NCT ID: NCT01186848

Last Updated: 2021-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stretch Marks

Keywords

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Stretch marks Striae distensae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1550-nm erbium-doped fractionated laser

Group Type ACTIVE_COMPARATOR

1550-nm erbium-doped fractionated laser

Intervention Type 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.

Combination treatment

"micro-focused ultrasound" and "1550nm-fractionated laser"

Group Type ACTIVE_COMPARATOR

Combination treatment

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Professor in Dermatology, Otolaryngology - Head and Neck Surgery and Surgery-Organ Transplantation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University Department of Dermatology

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU34376

Identifier Type: -

Identifier Source: org_study_id