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

NCT02452359 | Terminated Results DMC

• 1 other identifier: CS0315
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

stretch marks

Outcome Measures

Primary Outcomes (1)

• Improvement in Striae Distensae Appearance

  Striae distensae appearance improvement by at least 1 point on the Global Aesthetic Improvement scale (GAIS) from photographs 3 months following the last treatment as determined by 3 blinded reviewers where 3 = Very Much Improved, 2 = Much Improved, 1 = Improved, 0 = No Change, -1 = Worse, -2 = Much Worse and -3 = Very Much Worse.

  90 days following last IPL treatment

Study Arms (1)

Treatment Group

EXPERIMENTAL

Group receiving treatment with Venus Versa IPL energy

Device: Venus Versa

Interventions

Venus Versa DEVICE

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.

Treatment Group

Eligibility Criteria

• Age: 24 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (1)

Rosenberg Plastic Surgery

Beverly Hills, California, 90211, 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: Yoni Iger
• Organization: Venus Concept Ltd

yoni@venusconcept.com

888-907-0115

Study Officials

• Tracey L Mancuso

  Venus Concept

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label study where all subjects assigned to receive 5 treatments every 2 weeks. Subjects acted as their own control.

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: May 22, 2015
• Study Start: March 13, 2015
• Primary Completion: February 15, 2017
• Study Completion: March 31, 2017
• Last Updated: November 3, 2020
• Results First Posted: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)