Clinical trial NCT03573271: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Laxity; Skin
Keywords: facial wrinkles
skin laxity
sagging skin
Lead sponsor: Cytrellis Biosystems, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-29
Enrollment: 20
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 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

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

Primary outcomes:
measure: Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale at 90 days post treatment
timeFrame: 90 day post treatment
Secondary outcomes:
measure: Assess safety profile by recording of adverse events
timeFrame: 90 days
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser and Skin Surgery Center of Northern California
state: California
city: Miami
country: United States
facility: Miami Dermatology and Laser Institute
state: Florida
city: New York
country: United States
facility: Laser and Skin Surgery Center of New York
state: New York
city: Nashville
country: United States
facility: The Practice of Brian S. Biesman, M.D
state: Tennessee
city: Dallas
country: United States
facility: Dr A Jay Burns Cosmetic Surgery
state: Texas
Study officials:
References: