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The INFORM Study: Rotational Fractional Resection for Submental Contouring

Primary Purpose

Skin Laxity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focal Contouring System
Sponsored by
Recros Medica, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Laxity focused on measuring submental, laxity

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Aesthetx
  • Clinical Testing of Beverly Hills
  • Westside Aesthetics
  • ATS Clinical Research
  • Moradi MD
  • AboutSkin Research
  • Washington Institute of Dermatologic Laser Surgery
  • DeNova Research
  • Juva Skin and Laser Center
  • Clinical Research Center of the Carolinas
  • Brian Biesman, MD
  • Bellaire Dermatology Associates
  • Sundaram Dermatology, Cosmetic & Laser Surgery Center
  • Premier Clinical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rotational fractional resection (RFR)

Arm Description

Single treatment of skin resection (removal of loose skin)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 21, 2019
Last Updated
March 5, 2020
Sponsor
Recros Medica, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03853980
Brief Title
The INFORM Study: Rotational Fractional Resection for Submental Contouring
Official Title
The INFORM Study: A Multi-Center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring With an Optimized Post-Procedure Treatment Plan
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
October 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Recros Medica, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Efficacy and safety of Rotational Fractional Resection (skin resection) in patients with moderate to severe submental skin laxity.
Detailed Description
This is a prospective, multi-center, single-arm (non-randomized), interventional cohort, non-significant risk (NSR) study designed to investigate the efficacy and safety of Rotational Fractional Resection (skin resection) in patients with moderate to severe submental skin laxity. The total duration of study participation for each subject is approximately up to 4 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 3 months after the procedure. Eligible subjects will complete a total of 11 study visits: screening, procedure, and follow-up visits at 1, 2-4, 7, 14, 21, 30, 45, 60, and 90 days post-procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity
Keywords
submental, laxity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotational fractional resection (RFR)
Arm Type
Experimental
Arm Description
Single treatment of skin resection (removal of loose skin)
Intervention Type
Device
Intervention Name(s)
Focal Contouring System
Intervention Description
Single treatment of skin resection (removal of loose skin)
Primary Outcome Measure Information:
Title
Improved Skin Laxity
Description
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)
Time Frame
Pre-treatment and 90 days after treatment
Title
Subject Satisfaction: Subject Satisfaction Questionnaire
Description
Comparison of Subject satisfaction of the procedure as assessed using the Subject Satisfaction Questionnaire
Time Frame
Pre-treatment and 90 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin McIntosh
Organizational Affiliation
Recros Medica
Official's Role
Study Director
Facility Information:
Facility Name
Aesthetx
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Clinical Testing of Beverly Hills
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Westside Aesthetics
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
ATS Clinical Research
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Moradi MD
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
AboutSkin Research
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Washington Institute of Dermatologic Laser Surgery
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20005
Country
United States
Facility Name
DeNova Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Juva Skin and Laser Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Clinical Research Center of the Carolinas
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Brian Biesman, MD
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Bellaire Dermatology Associates
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Sundaram Dermatology, Cosmetic & Laser Surgery Center
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The INFORM Study: Rotational Fractional Resection for Submental Contouring

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