N/A N=68 Treatment

CONFORM: Rotational Fractional Resection for Submental Contouring

Skin Laxity · Lipodystrophy

Bottom Line

View on ClinicalTrials.gov: NCT03407313 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2 — 49 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: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2	49	—
SECONDARY Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline	56	—
SECONDARY Number of Participants With Post-treatment Images Correctly Identified	59; 67; 67	—

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.

Eligibility Criteria

Inclusion Criteria

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

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
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03407313). 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.