The INFORM Study: A Multi-Center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring
| Status: | Recruiting |
|---|---|
| Conditions: | Endocrine, Gastrointestinal, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Endocrinology, Gastroenterology |
| Healthy: | No |
| Age Range: | 30 - Any |
| Updated: | 3/22/2019 |
| Start Date: | March 18, 2019 |
| End Date: | July 1, 2019 |
| Contact: | Robin McIntosh |
| Email: | rmcintosh@recrosmedica.com |
| Phone: | 714-309-7667 |
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
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
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.
non-significant risk (NSR) study designed to investigate the efficacy and safety of
Rotational Fractional Resection (skin resection and focal lipectomy) 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.
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
We found this trial at
1
site
Fairfax, Virginia 22031
Principal Investigator: Hema Sundaram, MD
Phone: 703-641-9666
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