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

NCT03793348 | Unknown FDA Device

• 1 other identifier: AIS 700-00052
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Wrinkle

Keywords

facial wrinkles; skin laxity; sagging skin

Outcome Measures

Primary Outcomes (1)

• Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale

  A mean change of 1 point or greater reduction in cheek wrinkle severity at 90 days post treatment using the Lemperle Wrinkle Severity Scale, as assessed by (3) blinded Independent Reviewers Lemperle Scale: No wrinkles =0 Just perceptible wrinkles =1 Shallow wrinkles=2 Moderately deep wrinkles=3 Deep wrinkles, well-defined edges =4 Very deep wrinkles, redundant fold=5

  90 day post treatment

Secondary Outcomes (6)

• Assess aesthetic improvement using Global Aesthetic Improvement Scale

  90 day post treatment

• Assess aesthetic improvement using Subject Satisfaction Scale

  90 day post treatment

• Assess aesthetic improvement in wrinkles using OCT images (optional)

  Baseline to Day 90 post treatment

• Assess efficacy results using Canfield Software,, by comparing the changes in wrinkles at baseline and 90 days post treatment.

  Baseline to Day 90 post treatment

• Assess safety profile by recording of adverse events

  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.

Study Arms (1)

Micro-exisional skin removal

EXPERIMENTAL

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

Device: MCD

Interventions

MCD DEVICE

Micro coring skin removal with automated coring device

Micro-exisional skin removal

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cytrellis Biosystems, Inc.: lead

Study Sites (6)

Laser and Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

ACTIVE NOT RECRUITING

AboutSkin Research, LLC

Greenwood Village, Colorado, 80111, United States

NOT YET RECRUITING

Miami Dermatology & Laser Institute

Miami, Florida, 33173, United States

ACTIVE NOT RECRUITING

Laser and Skin Surgery of New York

New York, New York, 10016, United States

RECRUITING

The Office of Brian Biesman, M.D.

Nashville, Tennessee, 37203, United States

ACTIVE NOT RECRUITING

Dallas Plastic Surgery Institute

Dallas, Texas, 75231, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: January 4, 2019
• Study Start: November 12, 2018
• Primary Completion: June 15, 2019
• Study Completion: August 21, 2019
• Last Updated: January 4, 2019

Record last verified: 2019-01

Locations

US (6)