Pivotal Study to Evaluate the Effectiveness of a Micro-coring Device Treating Moderate to Severe Facial Wrinkles
Primary Purpose
Laxity; Skin
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MCD
Sponsored by
About this trial
This is an interventional treatment trial for Laxity; Skin focused on measuring facial wrinkles, skin laxity, sagging skin
Eligibility Criteria
Inclusion Criteria:
- Males and females 40-70 years of age
- Fitzpatrick Skin Type I to IV as judged by the Investigator.
- Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as judged by the Investigator
- Able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits
Exclusion Criteria:
- Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated
- History of keloid formation or hypertrophic scarring
- History of trauma or surgery to the treatment areas in the past 6 months
- Scar present in the areas to be treated
- Silicone injections in the areas to be treated
- Injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, RF devices)
- Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment
- Active, chronic, or recurrent infection
- History of compromised immune system or currently being treated with immunosuppressive agents
- History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or epinephrine
- Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment
- Treatment with aspirin or other blood thinning agents within 14 days prior to treatment
- History or presence of any clinically significant bleeding disorder
- Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to participate in the study
- Treatment with an investigational device or agent within 30 days before treatment or during the study period
- Female and pregnant or plan on becoming pregnant during the study
Sites / Locations
- Laser and Skin Surgery Center of Northern California
- Miami Dermatology and Laser InstituteRecruiting
- Laser and Skin Surgery Center of New York
- The Practice of Brian S. Biesman, M.D
- Dr A Jay Burns Cosmetic Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Micro-coring of facial/neck skin with MCD
Arm Description
Micro coring of facial and neck skin will be conducted in up to 2 treatments and followed 90 days post treatment with MCD
Outcomes
Primary Outcome Measures
Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale at 90 days post treatment
Assess level of wrinkle improvement from the baseline to 90 day post treatment an Independent Reviewer(s) using the Lemperle Wrinkle Severity Scale
Secondary Outcome Measures
Assess safety profile by recording of adverse events
Adverse events will be recorded throughout the study
Full Information
NCT ID
NCT03573271
First Posted
June 14, 2018
Last Updated
June 27, 2018
Sponsor
Cytrellis Biosystems, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03573271
Brief Title
Pivotal Study to Evaluate the Effectiveness of a Micro-coring Device Treating Moderate to Severe Facial Wrinkles
Official Title
A Prospective, Multi-center, Pivotal Study to Evaluate the Safety and Efficacy of a Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2018 (Actual)
Primary Completion Date
January 15, 2019 (Anticipated)
Study Completion Date
March 21, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytrellis Biosystems, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study evaluating the effectiveness of a micro-coring device for the treatment of moderate to severe cheek wrinkles.
Detailed Description
Up to 60 subjects who meet the Inclusion/Exclusion criteria will be treated. All subjects will be monitored for a period of 90 days after treatments.
Evaluation results will be based in the following:
Wrinkle severity score assessed using the Lemperle Wrinkle Scale
Subject Satisfaction Scale
PI Global Aesthetic Improvement Scale
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laxity; Skin
Keywords
facial wrinkles, skin laxity, sagging skin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Micro-coring of facial/neck skin with MCD
Arm Type
Experimental
Arm Description
Micro coring of facial and neck skin will be conducted in up to 2 treatments and followed 90 days post treatment with MCD
Intervention Type
Device
Intervention Name(s)
MCD
Intervention Description
Micro-coring skin removal with automated coring device
Primary Outcome Measure Information:
Title
Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale at 90 days post treatment
Description
Assess level of wrinkle improvement from the baseline to 90 day post treatment an Independent Reviewer(s) using the Lemperle Wrinkle Severity Scale
Time Frame
90 day post treatment
Secondary Outcome Measure Information:
Title
Assess safety profile by recording of adverse events
Description
Adverse events will be recorded throughout the study
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males and females 40-70 years of age
Fitzpatrick Skin Type I to IV as judged by the Investigator.
Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as judged by the Investigator
Able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits
Exclusion Criteria:
Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated
History of keloid formation or hypertrophic scarring
History of trauma or surgery to the treatment areas in the past 6 months
Scar present in the areas to be treated
Silicone injections in the areas to be treated
Injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, RF devices)
Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment
Active, chronic, or recurrent infection
History of compromised immune system or currently being treated with immunosuppressive agents
History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or epinephrine
Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment
Treatment with aspirin or other blood thinning agents within 14 days prior to treatment
History or presence of any clinically significant bleeding disorder
Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to participate in the study
Treatment with an investigational device or agent within 30 days before treatment or during the study period
Female and pregnant or plan on becoming pregnant during the study
Facility Information:
Facility Name
Laser and Skin Surgery Center of Northern California
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Miami Dermatology and Laser Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Rieth
Phone
305-279-6060
Email
nicoler@miamidermlaser.com
First Name & Middle Initial & Last Name & Degree
Jill Waibel, MD
Facility Name
Laser and Skin Surgery Center of New York
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Schmidt
Phone
212-686-7306
First Name & Middle Initial & Last Name & Degree
Roy Geroneumus, MD
Facility Name
The Practice of Brian S. Biesman, M.D
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dr A Jay Burns Cosmetic Surgery
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casey Martin
Phone
603-332-5211
First Name & Middle Initial & Last Name & Degree
A. Jay Burns, MD
12. IPD Sharing Statement
Learn more about this trial
Pivotal Study to Evaluate the Effectiveness of a Micro-coring Device Treating Moderate to Severe Facial Wrinkles
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