CS0315

About this trial

Last updated 5 years ago

Study ID

CS0315

Status

Terminated

Type

Interventional

Phase

N/A

Placebo

Accepting

24 to 65 Years

All

Trial Timing

Ended 8 years ago

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.

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

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