Clinical Evaluation of Venus Versa SR Applicator Using Intense Pulsed Light on Skin Texture for Improving the Appearance of Striae Distensae
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Venus Concept
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Improvement in Striae Distensae Appearance
Overview
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.
Detailed Description
Study Design This is a multi-site, prospective, open labeled clinical trial with before-after study design. This study will include up to 8 visits at the clinic: initial screening/consultation, 5 treatments, visits in 2 week intervals, and 2 follow-up visits at 1 and 3 months after the last treatment visit.
Up to 60 healthy subjects age 24-65 with Striae Distensae will be enrolled.
Study duration:
Duration of subject's participation: Up to 5.5 months from enrollment to termination
Blinding Objective assessment of clinical improvement by global assessment scale will be achieved by sending before/after pictures (baseline/3months after last treatment) to 3 blinded reviewers at the end of the study.
Study Procedures Test Spots Up to 3 test spots will be performed in the selected treatment area to determine the optimal parameters / settings
Treatment visits Each subject will be enrolled and scheduled for 5 treatments at 2 week intervals and return for follow-up visits at one month and 3 months after the last treatment for evaluation of the treated areas. The duration of the entire treatment visit is approximately 60 minutes.
Treatment The treatment areas are divided into 2 treatment areas: abdomen or thighs. Apply a thin layer of IPL gel. Place the applicator in close contact, perpendicular to the skin with no pressure applied. Pressing the applicator will fire the IPL pulse.
Administer pulses throughout the treated area to ensure full coverage of the treated area with applicator overlap approximately 1/3 of the previously treated skin.
A single pass over the area is completed Remove the remnants of the IPL gel and dry thoroughly. Cold air or cold, wet but not frozen gauze pads may be placed on the treated area for post treatment cooling.
Typical responses to the treatment are mild erythema and edema.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 24 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Improvement in Striae Distensae Appearance
Time Frame: 90 days following last IPL treatment
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.
Secondary Outcomes
No secondary outcomes reported