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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wrinkle treatment | Experimental | Wrinkle treatment with ResurFX 1565nm module |
|
| Striae treatment | Experimental | Striae treatment with the REsurFX 1565nm module |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M22 ResurFX module | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement | Investigator subjective evaluation of the extent of wrinkles improvement at the 3 month follow-up visit as assessed by Fitzpatrick-Goldman Wrinkle Class / Elastosis Score classification, striae improvement will be assessed using VAS. | 3 months following 3rd treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement | Investigator subjective evaluation of the extent of wrinkles/striae improvement by the investigator at 1 and 6 month follow-up visits as assessed by Fitzpatrick-Goldman Wrinkle Class / Elastosis Score classification, striae improvement will be assessed using VAS. | 1 and 6 months following 3rd treatment |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following will exclude the subject from the study: skin type V-VI
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| Name | Affiliation | Role |
|---|---|---|
| Mitchel P Goldman, MD | DCLA | Principal Investigator |
| Arielle NB Kauvar, MD | New York Laser & Skin Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DCLA | San Diego | California | United States | |||
| New York Laser & Skin Care |
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| ID | Term |
|---|---|
| D057896 | Striae Distensae |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Blinded improvement |
Blinded evaluation of wrinkles/striae skin improvement at the 1, 3 and 6 months follow-up as compared to baseline using photographs may 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 | Following treatment #1, 2 and 3 |
| 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 | Following treatment #1, 2 and 3 |
| Improvement by subject | Subject subjective opinion of improvement and satisfaction with the treatment based on a 5 point scale | 1, 3 and 6 months follow up |
| Comfort | Subject subjective assessment of pain and discomfort associated with treatments using a 10 point VAS scale | Following treatment #1, 2 and 3 |
| Biopsies | Histological analysis of tissue samples with different staining for analysis of changes following treatment | 1, 3 and 6 months follow up |
| Adverse Events | Any adverse events associated with various setting used during the treatment and follow-up period. | Following treatment #1, 2 and 3 and all follow up visits |
| New York |
| New York |
| 10028 |
| United States |