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

Stopped early · Not applicable

Conditions studied: Striae Distensae

In brief

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.

Key facts

Study ID

NCT02452359

Run by

Venus Concept

People needed

54

Starts

2015-03-13

Expected to finish

2017-03-31

Last updated by the study team

2020-11-03

Who can join

Age: 24 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to provide written Informed Consent;
• Healthy male or female, 24-65 years Fitzpatrick-Goldman skin type I-V;
• Having visible Striae Distensae to be treated (abdomen/thighs);
• Comply with the treatment/follow-up schedule and requirements;
• Women of child-bearing age are required to be using a reliable method of birth control

You may not qualify if…

• Fitzpatrick-Goldman skin type VI;
• Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after breastfeeding;
• Heavy smoker
• Unable or unlikely to refrain from tanning
• Use of photosensitive medication
• Use of oral isotretinoin within 3 months
• Any dermal/epidermal damage or disorder in treated area
• Prior treatment in treated area within 3 months
• Prior skin laser/light or another device treatment in treated area within 6 months
• Prior use of collagen, fat injections or other methods of skin augmentation in treated area within 12 months
• Prior use of Botox in treatment area within 6 months
• Prior ablative resurfacing procedure with laser in treatment area within 12 months
• Any other surgery in treated area within 9 months
• Participation in a study of another investigational device or drug as per the Investigator's discretion
• History of keloid or any other type of hypertrophic scar formation or poor wound healing in a previously injured skin area
• Showing symptoms of hormonal disorders (such as Melasma, Chloasma);
• Concurrent inflammatory skin conditions, open laceration or abrasion of any sort on area to be treated during the course of treatment
• Active Herpes Simplex at the time of treatment or having experienced more than three episodes of Herpes Simplex eruption within a year of study
• Multiple dysplastic nevi in area to be treated
• Having a bleeding disorder or taking anticoagulation medications
• History of immunosuppression/immune deficiency disorders
• Having any form of active cancer at the time of enrollment and during the course of the study or history of skin cancer
• Pigmented lesion in the treated area that appears cancerous
• Significant concurrent illness, such as uncontrolled diabetes
• Active infections in the treated area

Where it is running

• Rosenberg Plastic Surgery — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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