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The PREFORM Study: Rotational Fractional Resection for Submental Contouring

Primary Purpose

Skin Laxity, Lipodystrophy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rotational fractional resection (1.5mm Diameter Device)
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, lipodystrophy

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
  • Up to moderate submental lipodystrophy
  • Agree to maintain weight (±5%) for the duration of the study

Exclusion Criteria:

  • 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

  • Steve Yoelin, MD Medical Associates, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rotational fractional resection (1.5mm Diameter Device)

Arm Description

Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)

Outcomes

Primary Outcome Measures

Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale
Physician investigator rated the submental laxity using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)

Secondary Outcome Measures

Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline
Subjects rated their satisfaction of the appearance of their neck and jawline on a Subject Satisfaction Questionnaire. Results reflect subjects who were satisfied ("somewhat satisfied," "satisfied," or "very satisfied").
Number of Participants With a One Grade Improvement on the Submental Lipodystrophy Scale
Comparison of the submental fat before and after procedure using the Submental Skin Lipodystrophy scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)

Full Information

First Posted
March 19, 2019
Last Updated
April 20, 2021
Sponsor
Recros Medica, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03966924
Brief Title
The PREFORM Study: Rotational Fractional Resection for Submental Contouring
Official Title
The PREFORM Study: An Exploratory, Single-Center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring and Optimal Peri-Procedure Regimen for Accelerated Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
October 16, 2019 (Actual)
Study Completion Date
October 16, 2019 (Actual)

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
This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. Rotational fractional resection is used to remove loose skin and fat.
Detailed Description
This is a prospective, single-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 and focal lipectomy) 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, 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, Lipodystrophy
Keywords
submental, laxity, lipodystrophy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Rotational fractional resection (1.5mm Diameter Device)
Arm Type
Experimental
Arm Description
Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)
Intervention Type
Device
Intervention Name(s)
Rotational fractional resection (1.5mm Diameter Device)
Intervention Description
Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)
Primary Outcome Measure Information:
Title
Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale
Description
Physician investigator rated the submental laxity using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)
Time Frame
90 days post treatment
Secondary Outcome Measure Information:
Title
Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline
Description
Subjects rated their satisfaction of the appearance of their neck and jawline on a Subject Satisfaction Questionnaire. Results reflect subjects who were satisfied ("somewhat satisfied," "satisfied," or "very satisfied").
Time Frame
90 days post treatment
Title
Number of Participants With a One Grade Improvement on the Submental Lipodystrophy Scale
Description
Comparison of the submental fat before and after procedure using the Submental Skin Lipodystrophy scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)
Time Frame
90 days post 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 Up to moderate submental lipodystrophy Agree to maintain weight (±5%) for the duration of the study Exclusion Criteria: 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
Steve Yoelin, MD Medical Associates, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The PREFORM Study: Rotational Fractional Resection for Submental Contouring

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