Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT03583918
Status:
COMPLETED
Last Update Posted:
2018-07-12
First Post:
2017-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Micro-excisional Skin Removal by Micro-coring Device in Treatment of Wrinkles and Laxity of Face and Neck
Sponsor:
Cytrellis Biosystems, Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MCD
Brief Summary:
This is a prospective, multi-center, pilot study evaluating effectiveness of micro-excisional skin remodeling by micro-coring skin in subjects meeting the Inclusion Criteria. Subjects will undergo bilateral treatment on the face and neck (upper and lower cheek, upper and lower lip, periocular and perioral areas, submandibular and middle neck, etc). The exact treatment area(s), choice of treatment density are left to the Investigator's discretion and subject's consent. Up to 3 treatments are allowed with a minimum of 30-day between the consecutive treatments.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| AIS 700-00022 | OTHER | Cytrellis Biosystems, Inc. | View |