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

NCT ID: NCT02452359

Last Updated: 2020-11-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-13
• Study Completion Date: 2017-03-31

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.

Conditions

Striae Distensae

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

Group receiving treatment with Venus Versa IPL energy

Group Type: EXPERIMENTAL

Venus Versa

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Able to provide written Informed Consent;

2. Healthy male or female, 24-65 years Fitzpatrick-Goldman skin type I-V;

3. Having visible Striae Distensae to be treated (abdomen/thighs);

4. Comply with the treatment/follow-up schedule and requirements;

5. Women of child-bearing age are required to be using a reliable method of birth control

Exclusion Criteria

1. Fitzpatrick-Goldman skin type VI;

2. Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after breastfeeding;

3. Heavy smoker

4. Unable or unlikely to refrain from tanning

5. Use of photosensitive medication

6. Use of oral isotretinoin within 3 months

7. Any dermal/epidermal damage or disorder in treated area

8. Prior treatment in treated area within 3 months

9. Prior skin laser/light or another device treatment in treated area within 6 months

10. Prior use of collagen, fat injections or other methods of skin augmentation in treated area within 12 months

11. Prior use of Botox in treatment area within 6 months

12. Prior ablative resurfacing procedure with laser in treatment area within 12 months

13. Any other surgery in treated area within 9 months

14. Participation in a study of another investigational device or drug as per the Investigator's discretion

15. History of keloid or any other type of hypertrophic scar formation or poor wound healing in a previously injured skin area

16. Showing symptoms of hormonal disorders (such as Melasma, Chloasma);

17. Concurrent inflammatory skin conditions, open laceration or abrasion of any sort on area to be treated during the course of treatment

18. Active Herpes Simplex at the time of treatment or having experienced more than three episodes of Herpes Simplex eruption within a year of study

19. Multiple dysplastic nevi in area to be treated

20. Having a bleeding disorder or taking anticoagulation medications

21. History of immunosuppression/immune deficiency disorders

22. Having any form of active cancer at the time of enrollment and during the course of the study or history of skin cancer

23. Pigmented lesion in the treated area that appears cancerous

24. Significant concurrent illness, such as uncontrolled diabetes

25. 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

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Venus Concept

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tracey L Mancuso

Role: STUDY_DIRECTOR

Venus Concept

Locations

Rosenberg Plastic Surgery

Beverly Hills, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CS0315

Identifier Type: -

Identifier Source: org_study_id