Clinical trial NCT03793348: Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
Official title: A Prospective, Multi-center, Pivotal Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wrinkle
Keywords: facial wrinkles
skin laxity
sagging skin
Lead sponsor: Cytrellis Biosystems, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-04
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles

Detailed description: 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:

* Lemperle Scale
* Investigator GAIS Scale
* Subject Satisfaction Scale

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

Primary outcomes:
measure: Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale
timeFrame: 90 day post treatment
Secondary outcomes:
measure: Assess aesthetic improvement using Global Aesthetic Improvement Scale
timeFrame: 90 day post treatment
measure: Assess aesthetic improvement using Subject Satisfaction Scale
timeFrame: 90 day post treatment
measure: Assess aesthetic improvement in wrinkles using OCT images (optional)
timeFrame: Baseline to Day 90 post treatment
measure: Assess efficacy results using Canfield Software,, by comparing the changes in wrinkles at baseline and 90 days post treatment.
timeFrame: Baseline to Day 90 post treatment
measure: Assess safety profile by recording of adverse events
timeFrame: 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.
measure: Assess safety profile by reviewing completed 14 day subject diary for potential side effects.
timeFrame: For 14 days post treatment
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser and Skin Surgery Center of Northern California
state: California
city: Greenwood Village
country: United States
facility: AboutSkin Research, LLC
state: Colorado
city: Miami
country: United States
facility: Miami Dermatology & Laser Institute
state: Florida
city: New York
country: United States
facility: Laser and Skin Surgery of New York
state: New York
city: Nashville
country: United States
facility: The Office of Brian Biesman, M.D.
state: Tennessee
city: Dallas
country: United States
facility: Dallas Plastic Surgery Institute
state: Texas
Study officials:
References: