Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-10 @ 1:50 AM
Study NCT ID:
NCT02452359
Status:
TERMINATED
Last Update Posted:
2020-11-03
First Post:
2015-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Using Intense Pulsed Light for Improving the Appearance of Striae Distensae
Sponsor:
Venus Concept
Organization:
Study Overview
Official Title:
Clinical Evaluation of Venus Versa SR Applicator Using Intense Pulsed Light on Skin Texture for Improving the Appearance of Striae Distensae
Status:
TERMINATED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Continuing the trial was considered to be superfluous.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: