Clinical Evaluation of Using Intense Pulsed Light for Improving the Appearance of Striae Distensae
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|ClinicalTrials.gov Identifier: NCT02452359|
Recruitment Status : Terminated (Continuing the trial was considered to be superfluous.)
First Posted : May 22, 2015
Results First Posted : November 3, 2020
Last Update Posted : November 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Striae Distensae||Device: Venus Versa||Not Applicable|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label study where all subjects assigned to receive 5 treatments every 2 weeks. Subjects acted as their own control.|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of Venus Versa SR Applicator Using Intense Pulsed Light on Skin Texture for Improving the Appearance of Striae Distensae|
|Actual Study Start Date :||March 13, 2015|
|Actual Primary Completion Date :||February 15, 2017|
|Actual Study Completion Date :||March 31, 2017|
Experimental: Treatment Group
Group receiving treatment with Venus Versa IPL energy
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452359
|United States, California|
|Rosenberg Plastic Surgery|
|Beverly Hills, California, United States, 90211|
|Study Director:||Tracey L Mancuso||Venus Concept|