Clinical trial NCT03407313: CONFORM: Rotational Fractional Resection for Submental Contouring
Official title: The CONFORM Study: A Multi-center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Lipodystrophy
Keywords: Submental fullness
Submental fat
Loose skin
Lead sponsor: Recros Medica, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-23
Enrollment: 68
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 and focal lipectomy) in patients with mild to moderate submental fat and mild to moderate submental skin laxity. The total duration of study participation for each subject is approximately up to 7 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 6 months after the procedure. Eligible subjects will complete a total of 8 study visits: screening, procedure, and follow-up visits at 1, 7, 14, 30, 90 and 180 days post-procedure.

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

Primary outcomes:
measure: Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2
timeFrame: Baseline and 90 days post treatment
Secondary outcomes:
measure: Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline
timeFrame: 90 days after treatment
measure: Number of Participants With Post-treatment Images Correctly Identified
timeFrame: Pre-treatment and 90 days after treatment
Other outcomes:
Locations:
city: Campbell
country: United States
facility: Aesthetx
state: California
city: Newport Beach
country: United States
facility: Steve Yoelin, MD Medical Associates, Inc.
state: California
city: Roseville
country: United States
facility: Roseville Facial Plastic Surgery
state: California
city: Miami
country: United States
facility: Miami Dermatology & Laser Institute
state: Florida
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
city: Fairfax
country: United States
facility: Sundaram Dermatology, Cosmetic & Laser Surgery Center
state: Virginia
Study officials:
affiliation: Recros Medica, Inc.
name: Edward W Knowlton, MD
role: STUDY_DIRECTOR
References: