The INFORM Study: Rotational Fractional Resection for Submental Contouring

Status unconfirmed · Not applicable

Conditions studied: Skin Laxity

In brief

Efficacy and safety of Rotational Fractional Resection (skin resection) in patients with moderate to severe submental skin laxity.

Key facts

Study ID

NCT03853980

Run by

Recros Medica, Inc.

People needed

21

Starts

2019-03-18

Expected to finish

2020-10-31

Last updated by the study team

2020-03-06

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Aesthetx — Campbell, California, United States
• Clinical Testing of Beverly Hills — Encino, California, United States
• Westside Aesthetics — Los Angeles, California, United States
• ATS Clinical Research — Santa Monica, California, United States
• Moradi MD — Vista, California, United States
• AboutSkin Research — Greenwood Village, Colorado, United States
• Washington Institute of Dermatologic Laser Surgery — Washington D.C., District of Columbia, United States
• DeNova Research — Chicago, Illinois, United States
• Juva Skin and Laser Center — New York, New York, United States
• Clinical Research Center of the Carolinas — Charleston, South Carolina, United States
• Brian Biesman, MD — Nashville, Tennessee, United States
• Bellaire Dermatology Associates — Bellaire, Texas, United States
• Sundaram Dermatology, Cosmetic & Laser Surgery Center — Fairfax, Virginia, United States
• Premier Clinical Research — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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