Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles

Part of paid clinical trials in Sacramento, California.

Sponsor
Cytrellis Biosystems, Inc.
Study ID
NCT03793348
Status
Recruiting

Conditions

  • Wrinkle

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • MCD — DEVICE
    Micro coring skin removal with automated coring device

Study Details

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

Key Dates

Start date
Nov 12, 2018
Status verified
Jan 2019
Primary completion
Jun 15, 2019
Completion
Aug 21, 2019

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Micro-exisional skin removal
    Micro-coring of skin on the facial and neck areas will be conducted in one treatment and followed for 90 days post treatment.

Primary Outcome Measure

Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale [ Time Frame: 90 day post treatment ]

Locations (6)

FacilityCityStateZIPSite coordinators
Laser and Skin Surgery Center of Northern CaliforniaSacramentoCalifornia95816-
AboutSkin Research, LLCGreenwood VillageColorado80111
Audrey Langhorst
303-756-7546
Miami Dermatology & Laser InstituteMiamiFlorida33173-
Laser and Skin Surgery of New YorkNew YorkNew York10016
Jennifer Moreno
212-686-7306
Roy Geronemus (PRINCIPAL_INVESTIGATOR)
The Office of Brian Biesman, M.D.NashvilleTennessee37203-
Dallas Plastic Surgery InstituteDallasTexas75231
Casey Martin
214-823-1978
Jay Burns (PRINCIPAL_INVESTIGATOR)

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