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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ResurFX treatment | Experimental | Fractional Non Ablative (NA) treatment on one side of the face with the M22 ResurFX module |
|
| M22 ResurFX and QS treatment | Experimental | Fractional NA treatment with the M22 ResurFX followed by Q-Switched (QS) laser treatment (SST) on one side of the face |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M22 ResurFX | Device | Fractional NA treatment (ResurFX) on one side of the face |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement | Investigator subjective evaluation of the extent of wrinkles/elastosis as well as general skin tone improvement of each side of the face at the 3 month follow-up visit as assessed by Fitzpatrick-Goldman Wrinkle Class / Elastosis Score classification and by percentage category scales | 3 months following 3rd treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement | Investigator subjective evaluation of the extent of wrinkles/elastosis as well as general skin tone improvement of each side of the face at 1 and 6 month follow-up visits as assessed by Fitzpatrick-Goldman Wrinkle Class / Elastosis Score classification and by percentage category scales | 1 and 6 months following 3rd treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Girish (Gilly) Munavalli, MD | Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC | Charlotte | North Carolina | 28207 | United States |
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| M22 ResurFX and QS |
| Device |
Fractional NA treatment followed by QS laser treatment (SST) on one side of the face |
|
| Blinded improvement |
Blinded evaluation of wrinkles and general skin tone improvement at the 1, 3 and 6 months follow-up as compared to baseline using photographs will be performed at the end of the study |
| 1 year following study initiation |
| Skin response | Investigator subjective evaluation of skin response following each treatment defined as severity of response and the time it took for it subside for each side of the face | Following treatments- Baseline, 4, 8 weeks |
| Downtime | Downtime defined as the period of time following the procedure during which the subject felt uncomfortable, unwilling or unable to go out in public due to edema and erythema for each side of the face | Following treatment- baseline, 4, 8 weeks |
| Improvement by subject | Subject subjective opinion of improvement and satisfaction with the treatment based on a percentage category scale for each side of the face | 1, 3 and 6 months follow up |
| Comfort | Subject subjective assessment of pain and discomfort associated with treatments using a 10 point VAS scale for each side of the face | Following treatment- baseline, 4, 8 weeks |
| Biopsies | Histological analysis of pre auricular tissue samples from both treatment sides with different staining for analysis of changes following treatment | Immediately post 1st treatment or at 1, 3 or 6 month post last treatment |
| Adverse Events | Safety will be determined by examining the post-treatment occurrences of complications and adverse events throughout the study. | Following treatment #1, 2 and 3 and all follow up visits |