EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)



Status:Completed
Conditions:Cardiology, Cosmetic
Therapuetic Areas:Cardiology / Vascular Diseases, Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:11/8/2017
Start Date:February 2016
End Date:September 2016

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The study will evaluate the safety, effectiveness, and immunogenicity of EN3835 in the
treatment of adult women with Edematous Fibrosclerotic Panniculopathy (Commonly known as
Cellulite).


Inclusion Criteria:

- Be a female ≥18 years of age

- At Screening visit, have at least 1 quadrant with:

- a score of 3 or 4 (moderate or severe) as reported by the subject (PR- PCSS), and

- a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS),
and

- a Hexsel CSS score no greater than 13

- At Day 1 visit, have an assigned quadrant with:

- a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and

- a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS),
and

- a Hexsel CSS score no greater than 13

- Be willing to apply sunscreen to the selected treatment quadrant before each exposure
to the sun while participating in the study (ie, screening through end of study).

- Be judged to be in good health, based upon the results of a medical history, physical
examination, and laboratory profile at screening

- Have a negative urine pregnancy test at screening and be using an effective
contraception method (eg, abstinence, intrauterine device [IUD], hormonal
[estrogen/progestin] contraceptives, or double barrier method) for at least 1
menstrual cycle prior to study enrollment and for the duration of the study; or be
menopausal defined as 12 months of amenorrhea in the absence of other biological or
physiological causes, as determined by the investigator; or post-menopausal for at
least 1 year; or be surgically sterile.

- Be willing and able to cooperate with the requirements of the study

- Voluntarily sign and date an informed consent agreement approved by the Institutional
Review Board/Independent Ethics Committee/Human Research Ethics Committee
(IRB/IEC/HREC).

- Be able to read, complete and understand the Patient Reported Outcomes rating
instruments in English

Exclusion Criteria:

- Has any of the following conditions:

- Thyroid disease, unless controlled with medication for ≥6 months

- Uncontrolled diabetes mellitus, as determined by the Investigator

- Uncontrolled hypertension, as determined by the Investigator

- Vascular disorder (eg, phlebitis or varicose veins) in area to be treated

- Cushing's disease and/or use of systemic corticosteroids at a total daily dose
greater than 5 mg prednisone (or equivalent)

- History of lower extremity thrombosis or post-thrombosis syndrome

- Documented autoimmune disorder such as lupus erythematosus, rheumatoid arthritis

- Inflammation or active infection in area to be treated

- Active cutaneous alteration in area to be treated including rash, eczema,
psoriasis or skin cancer

- History of keloidal scarring or abnormal wound healing

- Coagulation disorder

- Taking a medication for chronic anticoagulation (except for ≤150 mg aspirin
daily)
We found this trial at
17
sites
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Pflugerville, TX
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2095 Langhorne Road
Lynchburg, Virginia 24501
434-847-8400
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Lynchburg, VA
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911 Park Avenue
New York, New York 10075
212-710-9855
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New York, NY
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Beverly Hills, California 90210
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Beverly Hills, CA
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Charlottesville, Virginia 22911
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Charlottesville, VA
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Clearwater, Florida 33757
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Clearwater, FL
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Clearwater, Florida 33757
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Clearwater, FL
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Coral Gables, Florida 33146
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Coral Gables, FL
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High Point, North Carolina 27262
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mi
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High Point, NC
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Murrieta, California 92562
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mi
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Murrieta, CA
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Nashville, Tennessee 37215
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from
Nashville, TN
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New York, New York 10065
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New York, NY
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Oceanside, California 92056
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Oceanside, CA
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San Diego, CA
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Spokane, Washington 99204
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Spokane, WA
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Washington, Missouri 63090
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from
Washington, MO
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West Palm Beach, Florida 33401
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mi
from
West Palm Beach, FL
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