Clinical Evaluation of M22 ResurFX 1565nm Module

NCT ID: NCT01796626

Last Updated: 2014-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-07-31

Brief Summary

At least thirty (30) subjects, Fitzpatrick-Goldman Skin Type I-IV will be enrolled in 2 clinical sites; each clinic will enroll at least 15 subjects.

Subjects should present visible wrinkles and/or striae requiring treatment.

Hypothesis: The M22 ResurFX 1565nm module will improve the appearance of the wrinkles by at least 2 grades on the Fitzpatrick-Goldman Wrinkle and Elastosis Score, and striae by at least 50% using VAS as compared to baseline, for at least 75% of the subjects.

Conditions

Wrinkles; Striae

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Wrinkle treatment

Wrinkle treatment with ResurFX 1565nm module

Group Type: EXPERIMENTAL

M22 ResurFX module

Intervention Type: DEVICE

The system delivers pulsed near Infra-Red (NIR) laser light with a nominal wavelength of 1565 nm and has a unique treatment handpiece with epidermal cooling. The clinician is able to control the settings of energy, µBeams density, scan size, and shape option from the user interface (LCD GUI) display on the main M22 console.

Striae treatment

Striae treatment with the REsurFX 1565nm module

Group Type: EXPERIMENTAL

M22 ResurFX module

Intervention Type: DEVICE

The system delivers pulsed near Infra-Red (NIR) laser light with a nominal wavelength of 1565 nm and has a unique treatment handpiece with epidermal cooling. The clinician is able to control the settings of energy, µBeams density, scan size, and shape option from the user interface (LCD GUI) display on the main M22 console.

Interventions

M22 ResurFX module

The system delivers pulsed near Infra-Red (NIR) laser light with a nominal wavelength of 1565 nm and has a unique treatment handpiece with epidermal cooling. The clinician is able to control the settings of energy, µBeams density, scan size, and shape option from the user interface (LCD GUI) display on the main M22 console.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Able to read, understand and provide written Informed Consent;
• Healthy adult, male or female, 25-55 years of age with Fitzpatrick-Goldman skin type I-IV;
• Having suitable areas of treatment of facial areas to be treated with wrinkles Fitzpatrick-Goldman Wrinkle and Elastosis Score of 3-6 or striae alba present for more than 1 year;
• Able and willing to 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 at least 3 months prior to enrollment and throughout the course of the study.

Exclusion Criteria

Any of the following will exclude the subject from the study: skin type V-VI

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

2. History of post inflammatory hyperpigmentation

3. Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study;

4. Use of photosensitive medication for which light exposure is contraindicated.

5. Use of oral isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study. Note: skin must regain its normal degree of moisture prior to treatment;

6. Prior treatment, such as chemical peel (especially phenol based) or dermabrasion, in treated area within 3 months of initial treatment or during the course of the study;

7. Prior skin treatment with non-ablative laser or other devices in treated area within 6 months of initial treatment or during the course of the study;

8. Prior use of collagen, fat injections or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 12 months of initial treatment or during the course of the study. Treatment may not be performed at all over permanent dermal implants;

9. Prior use of Botox in treatment area within 6 months;

10. Prior ablative resurfacing procedure or face lift in treated area with laser or other devices within 12 months of initial treatment or during the course of the study;

11. Any other surgery in treated area within 9 months of initial treatment or during the course of the study;

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

13. Showing symptoms of hormonal disorders, as per the Investigator's discretion (such as Melasma, Chloasma);

14. Concurrent inflammatory skin conditions, including, but not limited to, rosacea of any severity;

15. Open laceration or abrasion of any sort on area to be treated during the course of treatment;

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

17. Multiple dysplastic nevi in area to be treated;

18. Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to treatment (as per the patient's physician discretion);

19. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;

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

21. Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Investigator would interfere with the anesthesia, treatment, or healing process; Participation in a study of another device or drug within 3 month prior to study enrollment or during this study, and as per the Investigator's discretion, as long as not contradictory to any of the above criteria;

22. Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;

23. 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: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchel P Goldman, MD

Role: PRINCIPAL_INVESTIGATOR

DCLA

Arielle NB Kauvar, MD

Role: STUDY_DIRECTOR

New York Laser & Skin Care

Locations

DCLA

San Diego, California, United States

New York Laser & Skin Care

New York, New York, United States

Countries

United States

Other Identifiers

LUM-ABU-M22-ResurFX-12-01

Identifier Type: -

Identifier Source: org_study_id