Pivotal Study to Evaluate the Effectiveness of a Micro-coring Device Treating Moderate to Severe Facial Wrinkles

Laxity; Skin Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03573271
• Other study ID #: AIS 700-00041
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2018
• Est. completion date: March 21, 2019

Study information

• Verified date: June 2018
• Source: Cytrellis Biosystems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study evaluating the effectiveness of a micro-coring device for the treatment of moderate to severe cheek wrinkles.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 21, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cutis Laxa
• Laxity; Skin

Intervention

Device:
• MCD
Micro-coring skin removal with automated coring device

Locations

Country	Name	City	State
United States	Dr A Jay Burns Cosmetic Surgery	Dallas	Texas
United States	Miami Dermatology and Laser Institute	Miami	Florida
United States	The Practice of Brian S. Biesman, M.D	Nashville	Tennessee
United States	Laser and Skin Surgery Center of New York	New York	New York
United States	Laser and Skin Surgery Center of Northern California	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Cytrellis Biosystems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	90 day post treatment
Secondary	Assess safety profile by recording of adverse events	Adverse events will be recorded throughout the study	90 days