Condition of Submental Fullness and Treatment Outcomes Registry

Completed

Conditions studied: Submental Fullness

In brief

The primary objective of this registry is to develop a comprehensive understanding of the condition of submental (SM) fullness due to submental fat (SMF), how it is treated in current clinical practice, and the risks and benefits associated with its treatment.

Key facts

Study ID

NCT02438813

Run by

Kythera Biopharmaceuticals

People needed

1029

Starts

2015-05-11

Expected to finish

2016-11-10

Last updated by the study team

2018-10-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult male and female patients, aged 18 years and above, presenting with SM fullness due to the accumulation of unwanted SMF, and considered by their treating physician to be a candidate to receive treatment of SM fullness by reduction of SMF, if the patient decides
• Signed informed consent by the patient, obtained before any study-related activities are undertaken
• Willing to complete all patient assessment questionnaires
• Signed release form by the patient, permitting abstraction of the patient's medical records at baseline and during participation in the registry

You may not qualify if…

• Severe skin laxity, defined as superficial wrinkling, loose skin separated from deeper neck structures, and/or marked skin redundancy (draping and/or sagging), per the physician's judgment
• Any other cause of fullness in the SM area (eg, thyroid enlargement, cervical adenopathy) other than localized SMF
• Participating in an interventional clinical study, currently or within 30 days before enrollment

Where it is running

• John Joseph, MD — Beverly Hills, California, United States
• The Roxbury Institute — Beverly Hills, California, United States
• Brian M Kinney, MD Inc — Beverly Hills, California, United States
• Bella Skin Institute — Calabasas, California, United States
• Jerome R Potozkin MD — Danville, California, United States
• Kathleen L Behr — Fresno, California, United States
• Ocdermatology Lorrie Klein — Laguna Niguel, California, United States
• Westside Aesthetics — Los Angeles, California, United States
• Skin Care and Laser Physicians of Beverly Hills — Los Angeles, California, United States
• Batniji Facial Plastic Surgery — Newport Beach, California, United States
• Steve Yoelin, M.D. Medical Associates, Inc. — Newport Beach, California, United States
• Teleos Plastic Surgery &. Radiance Medical Group Inc — Pasadena, California, United States
• Laser And Skin Surgery Center Of Northern California — Sacramento, California, United States
• Dermatology Cosmetic Laser Medical Associates of La JollaInc — San Diego, California, United States
• FacesPlus — San Diego, California, United States
• Goldman Butterwick Fitzpatrick Groff And Fabi Cosmetic Laser — San Diego, California, United States
• The Maas Clinic - San Francisco — San Francisco, California, United States
• Bay Area Cosmetic Dermatology Kathleen M Welsh Md — San Francisco, California, United States
• Vic A Narurkar MD APC — San Francisco, California, United States
• Grossman Dermatology — Santa Monica, California, United States
• Art Of Skin MD — Solana Beach, California, United States
• Moradi Md — Vista, California, United States
• Practice Dr Mary Lynn Moran — Woodside, California, United States
• AboutSkin Dermatology and Dermsurg — Greenwood Village, Colorado, United States
• Skin Spectrum LLC — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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