Status:
UNKNOWN
The INFORM Study: Rotational Fractional Resection for Submental Contouring
Lead Sponsor:
Recros Medica, Inc.
Conditions:
Skin Laxity
Eligibility:
All Genders
30+ years
Phase:
NA
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 Resec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03853980
Start Date
March 18 2019
End Date
October 31 2020
Last Update
March 6 2020
Active Locations (14)
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1
Aesthetx
Campbell, California, United States, 95008
2
Clinical Testing of Beverly Hills
Encino, California, United States, 91436
3
Westside Aesthetics
Los Angeles, California, United States, 90025
4
ATS Clinical Research
Santa Monica, California, United States, 90404