NCT03853980

Brief Summary

Efficacy and safety of Rotational Fractional Resection (skin resection) in patients with moderate to severe submental skin laxity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

March 18, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

February 21, 2019

Last Update Submit

March 5, 2020

Conditions

Skin Laxity

Keywords

submentallaxity

Outcome Measures

Primary Outcomes (2)

  • Improved Skin Laxity

    Comparison of the submentum before and after procedure using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)

    Pre-treatment and 90 days after treatment

  • Subject Satisfaction: Subject Satisfaction Questionnaire

    Comparison of Subject satisfaction of the procedure as assessed using the Subject Satisfaction Questionnaire

    Pre-treatment and 90 days after treatment

Study Arms (1)

Rotational fractional resection (RFR)

EXPERIMENTAL

Single treatment of skin resection (removal of loose skin)

Device: Focal Contouring System

Interventions

Focal Contouring SystemDEVICE

Single treatment of skin resection (removal of loose skin)

Rotational fractional resection (RFR)

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or female
  • At least 30 years old
  • Moderate to severe submental laxity
  • Agree to maintain weight (±5%) for the duration of the study

You may not qualify if:

  • Greater than mild submental fat
  • Previous intervention to treat submental fat or skin laxity
  • Use of aspirin, ibuprofen, naproxen, or Vitamin E within 14 days of the procedure
  • Severe acne, cystic acne or acne scars on neck
  • Trauma of chin or neck area
  • Skin infection or rash on neck
  • Psoriasis, hyperpigmentation, eczema, rosacea or vitiligo
  • History of scarring
  • Body mass index (BMI) \>30
  • Clinically significant bleeding disorder
  • Anemia, kidney disease, or liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Aesthetx

Campbell, California, 95008, United States

Location

Clinical Testing of Beverly Hills

Encino, California, 91436, United States

Location

Westside Aesthetics

Los Angeles, California, 90025, United States

Location

ATS Clinical Research

Santa Monica, California, 90404, United States

Location

Moradi MD

Vista, California, 92083, United States

Location

AboutSkin Research

Greenwood Village, Colorado, 80111, United States

Location

Washington Institute of Dermatologic Laser Surgery

Washington D.C., District of Columbia, 20005, United States

Location

DeNova Research

Chicago, Illinois, 60611, United States

Location

Juva Skin and Laser Center

New York, New York, 10022, United States

Location

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

Brian Biesman, MD

Nashville, Tennessee, 37203, United States

Location

Bellaire Dermatology Associates

Bellaire, Texas, 77401, United States

Location

Sundaram Dermatology, Cosmetic & Laser Surgery Center

Fairfax, Virginia, 22031, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Robin McIntosh

    Recros Medica

    STUDY DIRECTOR

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

February 21, 2019

First Posted

February 26, 2019

Study Start

March 18, 2019

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(14)