Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles
Up to 35 subjects who meet the inclusion/exclusion criteria will be treated. All subjects will be monitored for a period of 90 days post treatment.
Study results will be assessed with the following:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micro-exisional skin removal | Experimental | Micro-coring of skin on the facial and neck areas will be conducted in one treatment and followed for 90 days post treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCD | Device | Micro coring skin removal with automated coring device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale | A mean change of 1 point or greater reduction in cheek wrinkle severity at 90 days post treatment using the Lemperle Wrinkle Severity Scale, as assessed by (3) blinded Independent Reviewers Lemperle Scale: No wrinkles =0 Just perceptible wrinkles =1 Shallow wrinkles=2 Moderately deep wrinkles=3 Deep wrinkles, well-defined edges =4 Very deep wrinkles, redundant fold=5 | 90 day post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Assess aesthetic improvement using Global Aesthetic Improvement Scale | Overall aesthetic improvement level per Principal Investigator at 90 days compared to baseline on the Global Aesthetic Improvement Scale. Very Much Improved (Optimal cosmetic result)=3 Much Improved (Marked improvement from the initial condition, but not completely optimal)=2 No Change (The appearance is essentially the same as baseline)=0 Worse (The appearance is worse than the original condition)= -1 Much Worse (Marked worsening in appearance from the initial condition)= - 2 Very Much Worse (Obvious worsening in appearance from the initial condition)=- 3 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser and Skin Surgery Center of Northern California | Active, not recruiting | Sacramento | California | 95816 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 90 day post treatment |
| Assess aesthetic improvement using Subject Satisfaction Scale | Satisfaction with the aesthetic appearance of the treatment area per Subject Satisfaction Scale compared to baseline. Extremely dissatisfied=0 Somewhat dissatisfied=1 Slightly dissatisfied=2 Neither satisfied or dissatisfied=3 Slightly satisfied=4 Somewhat satisfied=5 Extremely satisfied=6 | 90 day post treatment |
| Assess aesthetic improvement in wrinkles using OCT images (optional) | Assessment of improvement using OCT images with Vista software to determine wrinkle depth reduction, comparing pre-treatment depth to post treatment depth. | Baseline to Day 90 post treatment |
| Assess efficacy results using Canfield Software,, by comparing the changes in wrinkles at baseline and 90 days post treatment. | Validated Canfield software comparing baseline wrinkles to day 90 follow up wrinkles via automated photo analysis. | Baseline to Day 90 post treatment |
| Assess safety profile by recording of adverse events | The incidence and severity of systemic and local adverse events will be recorded by the PI at all visits and a 14 day diary completed by each subject will also be collected. | Adverse events will be recorded immediately treatment, Day 1, Day 7, Day 30, Day 60 and Day 90 post treatment. Ad hoc assessment can occur upon subject report of AE. |
| Assess safety profile by reviewing completed 14 day subject diary for potential side effects. | 14 day diary completed by each subject will record potential side effects, level of severity (mild = 1; moderate = 2; severe = 3), and end date of the potential side effects. | For 14 days post treatment |
| AboutSkin Research, LLC | Not yet recruiting | Greenwood Village | Colorado | 80111 | United States |
|
| Miami Dermatology & Laser Institute | Active, not recruiting | Miami | Florida | 33173 | United States |
| Laser and Skin Surgery of New York | Recruiting | New York | New York | 10016 | United States |
|
| The Office of Brian Biesman, M.D. | Active, not recruiting | Nashville | Tennessee | 37203 | United States |
| Dallas Plastic Surgery Institute | Not yet recruiting | Dallas | Texas | 75231 | United States |
|
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 6, 2026 | Apr 24, 2026 | 1 |
| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided