N/A
N=2
The PREFORM Study: Rotational Fractional Resection for Submental Contouring
Skin Laxity · Lipodystrophy
Bottom Line
View on ClinicalTrials.gov: NCT03966924 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale — 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rotational fractional resection (1.5mm Diameter Device) (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Recros Medica, Inc.
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale |
2 | — |
| SECONDARY Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline |
2 | — |
| SECONDARY Number of Participants With a One Grade Improvement on the Submental Lipodystrophy Scale |
2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03966924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.