Impact of Synergistic Sequential Treatment (SST)

NCT ID: NCT01940445

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-06-30

Brief Summary

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

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

Hypothesis: The SST will improve the appearance of the wrinkles/elastosis as well as general skin tone by at least 25% as compared to M22 ResurFX 1565nm module alone, for at least 75% of the subjects.

Conditions

Improvement of Wrinkles/Elastosis as Well as General Skin Tone

Study Design

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

Study Groups

ResurFX treatment

Fractional Non Ablative (NA) treatment on one side of the face with the M22 ResurFX module

Group Type: EXPERIMENTAL

M22 ResurFX

Intervention Type: DEVICE

Fractional NA treatment (ResurFX) on one side of the face

M22 ResurFX and QS treatment

Fractional NA treatment with the M22 ResurFX followed by Q-Switched (QS) laser treatment (SST) on one side of the face

Group Type: EXPERIMENTAL

M22 ResurFX and QS

Intervention Type: DEVICE

Fractional NA treatment followed by QS laser treatment (SST) on one side of the face

Interventions

M22 ResurFX

Fractional NA treatment (ResurFX) on one side of the face

Intervention Type: DEVICE

M22 ResurFX and QS

Fractional NA treatment followed by QS laser treatment (SST) on one side of the face

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Able to read, understand and provide written Informed Consent;

2. Healthy adult, male or female, 30-65 years of age with Fitzpatrick-Goldman skin type II-V;

3. Having suitable facial areas with wrinkles Fitzpatrick-Goldman Wrinkle and Elastosis Score of 3-6 to be treated;

4. Able and willing to 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 (such as an intrauterine device, birth control pills, condom with spermicidal, Nova ring, partner with vasectomy or abstinence) at least 3 months prior to enrollment and throughout the course of the study.

Exclusion Criteria

1. Skin type I, VI

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

3. History of post inflammatory hyperpigmentation

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

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

6. Use of oral isotretinoin (Accutane®) within 3 months of initial treatment or during the course of the study. Note: skin must regain its normal degree of moisture prior to treatment.

7. Having indurate acne, varicella scars, or severe open wound stages of rosacea.

8. Any dermal/epidermal damage or disorder, mainly vascular or textural lesions, in treated area

9. 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;

10. Prior skin laser/light or another device treatment in treated area within 6 months of initial treatment or during the course of the study

11. 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

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

13. 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

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

15. Participation in a study of another investigational device or drug involving the same anatomical site within 3 months prior to enrollment or during this evaluation, or if not involving the same anatomical site, as per the Investigator's discretion

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

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

18. Concurrent inflammatory skin conditions, including, but not limited to, severe rosacea

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

20. 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;

21. Multiple dysplastic nevi in area to be treated

22. 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 subject's physician discretion)

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

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

25. Pigmented lesion in the treated area that appears cancerous, pre-cancerous or is not deemed suitable for photo therapy, as determined by a dermatologist.

26. 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

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

28. 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.

29. For subjects undergoing test spots: considerable undesired response consisting of skin hypopigmentation (long term whitening), a scar or pre scar formation, or any response deemed by the Investigator as grounds for exclusion.

30. Allergies to anesthetics.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Girish (Gilly) Munavalli, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC

Locations

Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

LUM-ABU-M22-13-01

Identifier Type: -

Identifier Source: org_study_id