The INFORM Study: Rotational Fractional Resection for Submental Contouring
NCT ID: NCT03853980
Last Updated: 2020-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
21 participants
INTERVENTIONAL
2019-03-18
2020-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rotational fractional resection (RFR)
Single treatment of skin resection (removal of loose skin)
Focal Contouring System
Single treatment of skin resection (removal of loose skin)
Interventions
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Focal Contouring System
Single treatment of skin resection (removal of loose skin)
Eligibility Criteria
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Inclusion Criteria
* At least 30 years old
* Moderate to severe submental laxity
* 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
30 Years
ALL
Yes
Sponsors
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Recros Medica, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robin McIntosh
Role: STUDY_DIRECTOR
Recros Medica
Locations
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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
Countries
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Other Identifiers
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CLP-0006
Identifier Type: -
Identifier Source: org_study_id
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