Clinical trial NCT03853980: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Laxity
Keywords: submental
laxity
Lead sponsor: Recros Medica, Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-26
Enrollment: 21
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: 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.

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

Primary outcomes:
measure: Improved Skin Laxity
timeFrame: Pre-treatment and 90 days after treatment
measure: Subject Satisfaction: Subject Satisfaction Questionnaire
timeFrame: Pre-treatment and 90 days after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Campbell
country: United States
facility: Aesthetx
state: California
city: Encino
country: United States
facility: Clinical Testing of Beverly Hills
state: California
city: Los Angeles
country: United States
facility: Westside Aesthetics
state: California
city: Santa Monica
country: United States
facility: ATS Clinical Research
state: California
city: Vista
country: United States
facility: Moradi MD
state: California
city: Greenwood Village
country: United States
facility: AboutSkin Research
state: Colorado
city: Washington
country: United States
facility: Washington Institute of Dermatologic Laser Surgery
state: District of Columbia
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
city: New York
country: United States
facility: Juva Skin and Laser Center
state: New York
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
city: Nashville
country: United States
facility: Brian Biesman, MD
state: Tennessee
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: Fairfax
country: United States
facility: Sundaram Dermatology, Cosmetic & Laser Surgery Center
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
affiliation: Recros Medica
name: Robin McIntosh
role: STUDY_DIRECTOR
References: