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Clinical Evaluation of Using Intense Pulsed Light for Improving the Appearance of Striae Distensae

NCT02452359 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2020-11-03

Study results available
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Summary

This trial is intended to evaluate the effect of IPL treatment on the Striae Distensae. The study hypothesis is that the SR580 applicator will improve the appearance of Striae Distensae by at least 1 point on the Global Aesthetic Improvement ScaleI (GAIS) at 3 months follow-up compared to baseline in at least 50% of the study population.

Conditions

  • Striae Distensae

Interventions

DEVICE

Venus Versa

The Venus Versa system consists of a console and 4 detachable applicators that deliver optical energy in the form of Intense Pulsed Light to the patient skin. The intense pulsed light lamp delivers non-coherent light distributed over a range of wavelengths from 500 nm to 1200 nm. Different filters are embedded in the different applicators so that each applicator can deliver the desired spectrum according to the indications to be treated.In this study, the IPL applicator SR580 will be evaluated for the treatment of Striae Distensae, depending on the patient's skin type.

Sponsors & Collaborators

  • Venus Concept

    lead INDUSTRY

Principal Investigators

  • Tracey L Mancuso · Venus Concept

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
24 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-13
Primary Completion
2017-02-15
Completion
2017-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02452359 on ClinicalTrials.gov