Fractional Laser and Ultrasound for Striae Distensae

NCT01186848 | Completed Results DMC

• 1 other identifier: STU34376
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stretch Marks

Keywords

Stretch marks; Striae distensae

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1550-nm erbium-doped fractionated laser

ACTIVE COMPARATOR

Device: 1550-nm erbium-doped fractionated laser

Combination treatment

ACTIVE COMPARATOR

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

Device: Combination treatment

Interventions

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.

Combination treatment

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.

1550-nm erbium-doped fractionated laser

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Striae Distensae

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Murad Alam
• Organization: Northwestern University

m-alam@northwestern.edu

312-695-4761

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology - Head and Neck Surgery and Surgery-Organ Transplantation

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 23, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 3, 2021
• Results First Posted: February 3, 2014

Record last verified: 2021-12

Locations

US (1)