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

Primary Purpose

Striae Distensae

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Venus Versa

About this trial

This is an interventional treatment trial for Striae Distensae focused on measuring stretch marks

Eligibility Criteria

24 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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
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

28.Tattoo or permanent makeup at the treatment area. 29.Mentally incompetent, prisoner or evidence of active substance or alcohol abuse 30.Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study

Sites / Locations

Rosenberg Plastic Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

Group receiving treatment with Venus Versa IPL energy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02452359

First Posted

May 8, 2015

Last Updated

October 15, 2020

Sponsor

Venus Concept

1. Study Identification

Unique Protocol Identification Number

NCT02452359

Brief Title

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

Official Title

Clinical Evaluation of Venus Versa SR Applicator Using Intense Pulsed Light on Skin Texture for Improving the Appearance of Striae Distensae

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Terminated

Why Stopped

Continuing the trial was considered to be superfluous.

Study Start Date

March 13, 2015 (Actual)

Primary Completion Date

February 15, 2017 (Actual)

Study Completion Date

March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Venus Concept

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Striae Distensae

Keywords

stretch marks

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

Group receiving treatment with Venus Versa IPL energy

Intervention Type

Device

Intervention Name(s)

Venus Versa

Intervention Description

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.

Primary Outcome Measure Information:

Title

Improvement in Striae Distensae Appearance

Description

Time Frame

90 days following last IPL treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

24 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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 28.Tattoo or permanent makeup at the treatment area. 29.Mentally incompetent, prisoner or evidence of active substance or alcohol abuse 30.Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tracey L Mancuso

Organizational Affiliation

Venus Concept

Official's Role

Study Director

Facility Information:

Facility Name

Rosenberg Plastic Surgery

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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