NCT03407313

Brief Summary

This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. RFR is used to remove loose skin and fat.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

6 active sites

Status
completed

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

Study Start

First participant enrolled

January 8, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2019

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

February 3, 2021

Completed
Last Updated

February 3, 2021

Status Verified

January 1, 2021

Enrollment Period

12 months

First QC Date

January 16, 2018

Results QC Date

September 22, 2020

Last Update Submit

January 15, 2021

Conditions

Skin LaxityLipodystrophy

Keywords

Submental fullnessSubmental fatLoose skin

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2

    This endpoint is the difference in the measurement of submental skin area (mm\^2) between Baseline and 90 days. A reduction of ≥ 20 mm\^2 denotes improvement.

    Baseline and 90 days post treatment

Secondary Outcomes (2)

  • Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline

    90 days after treatment

  • Number of Participants With Post-treatment Images Correctly Identified

    Pre-treatment and 90 days after treatment

Study Arms (1)

Rotational fractional resection (1.5mm diameter device)

EXPERIMENTAL

Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)

Device: Rotational fractional resection (1.5mm diameter device)

Interventions

Rotational fractional resection (1.5mm diameter device)DEVICE

Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)

Rotational fractional resection (1.5mm diameter device)

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 submental (neck) fat
  • Mild to moderate submental (neck) skin laxity (loose skin)
  • Willing and able to provide informed consent
  • Willing and able to comply with all protocol requirements
  • Willing to limit direct sun exposure and use sunscreen for duration of the study
  • Agree to maintain weight for duration of the study
  • Willing to have photographs taken that could identify the participant

You may not qualify if:

  • Previous intervention to treat submental fat or skin laxity
  • Use of aspirin, ibuprofen, naproxen, or Vitamin E within 14 days of the procedure
  • Sensitivity to local anesthesia
  • Severe acne, cystic acne or acne scars on neck
  • Trauma of chin or neck area
  • Skin infection or rash on neck
  • Psoriasis, eczema, rosacea, or vitiligo
  • History of scarring
  • History or current symptoms of dysphagia
  • Chronic or persistent coughing
  • 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 (6)

Aesthetx

Campbell, California, 95008, United States

Location

Steve Yoelin, MD Medical Associates, Inc.

Newport Beach, California, 92663, United States

Location

Roseville Facial Plastic Surgery

Roseville, California, 95661, United States

Location

Miami Dermatology & Laser Institute

Miami, Florida, 33173, United States

Location

DeNova Research

Chicago, Illinois, 60611, United States

Location

Sundaram Dermatology, Cosmetic & Laser Surgery Center

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Cutis LaxaLipodystrophy

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesSkin Diseases, MetabolicLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Limitations and Caveats

This study evaluated 1.5mm diameter skin resections, our first-generation prototype, in the submentum area.

Results Point of Contact

Title
Head of Clinical Development
Organization
Recros Medica
clinical@recrosmedica.com
925-223-8581

Study Officials

  • Edward W Knowlton, MD

    Recros Medica, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

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

January 16, 2018

First Posted

January 23, 2018

Study Start

January 8, 2018

Primary Completion

December 28, 2018

Study Completion

April 23, 2019

Last Updated

February 3, 2021

Results First Posted

February 3, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(6)