Efficacy of Micro-excisional Skin Removal by Micro-coring Device in Treatment of Wrinkles and Laxity of Face and Neck (MCD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03583918|
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Laxity; Skin||Device: HighThroughput Micro Coring Device||Not Applicable|
The study will enroll up to 50 subjects at 6-8 investigational sites. It will evaluating effectiveness of a micro-coring device for micro-excisional skin remodeling in subjects with moderate to severe wrinkles of face and neck who meet the Inclusion/Exclusion Criteria. The choice of treatment density is at the investigator's discretion with the subject's consent. Up to 3 treatments may be performed with a minimum of 30-day interval between the consecutive treatments. Subjects will undergo bilateral micro-coring of skin on the face and upper neck, including but not limited to upper and lower cheek, upper and lower lip, periocular and perioral areas, submandibular and upper neck. The exact area(s) of treatment are left to the Investigator's discretion and subject's consent.
The subjects will be evaluated at each visit and following data will be collected:
- The incidence and severity of systemic and local adverse events.
- Wrinkle severity score assessed using the Lemperle Wrinkle Severity Scale.
- Changes in skin laxity assessed by Laxity Scale.
- Canfield Image Analyses.
- Needle and/or punch biopsy (in some subjects).
- Overall aesthetic improvement using the following scales:
- Subject and PI Global Aesthetic Improvement Scale (GAIS)
- Subject Satisfaction Scale
- Rhytides and Laxity Scale
- Lower face assessment
- Investigator evaluation of device usability and functionality. Data Analysis: Analyses will be conducted per measurement tools listed. Statistical analysis will include but will not be limited to T tests, univariate and multivariate analysis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multi-center, Pilot Study to Evaluate the Efficacy of Micro-Excisional Skin Remodeling With Micro-Coring Device in the Treatment of Wrinkles and Skin Laxity of Face and Neck|
|Actual Study Start Date :||June 1, 2017|
|Actual Primary Completion Date :||June 13, 2018|
|Actual Study Completion Date :||June 13, 2018|
Experimental: Highthroughput Micro Coring Device
Skin excision and removal with with Highthroughput Micro Coring device
Device: HighThroughput Micro Coring Device
Assess Safety and Efficacy for skin treatments through micro-excisional skin removal with micro-coring device
Other Name: skin micro-coring
- Assess wrinkle reduction for moderate to severe wrinkles at 90 days post treatment based on the Lemperle Wrinkle Scale [ Time Frame: 90-day post-treatment ]Assess wrinkle reduction in wrinkle severity score from the baseline assessed by Independent Reviewer(s) using the Lemperle Wrinkle Severity 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
- Assess skin laxity Improvement at 90 days post treatment [ Time Frame: 90-day post-treatment ]Improvement in skin laxity score from the baseline assessed by Independent Reviewer using Laxity Scale and supplemented by the Canfield Image Analyses. Global Aesthetic Improvement Scale: 3 Very Much Improved; 2 Much Improved; 1 Improved; 0 No Change; - 1 Worse; - 2 Much Worse; -3 Very Much Worse.
- Assess skin for new collagenases [ Time Frame: 60, 90, 180-day post treatment ]Histological changes in treated skin when compared to untreated skin consistent with new collagenases
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583918
|United States, California|
|Laser and Skin Surgery Center of Northern California|
|Sacramento, California, United States, 95816|
|United States, Florida|
|Miami Dermatology and Laser Institute|
|Miami, Florida, United States, 33173|
|United States, New York|
|Laser and Skin Surgery Center of New York|
|New York, New York, United States, 10016|
|United States, Tennessee|
|The Practice of Brian S. Biesman, M.D|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|Dr A Jay Burns Cosmetic Surgery|
|Dallas, Texas, United States, 75231|
|Study Director:||Patricia E Krantz, MBA||Cytrellis Biosystems, Inc.|