EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite) (NCT02724644) | Clinical Trial Compass
CompletedPhase 2
EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
United States375 participantsStarted 2016-02
Plain-language summary
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).
Who can participate
Age range18 Years
SexFEMALE
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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
* Volun…
What they're measuring
1
Percentage of Composite Responders of at Least 2-Level Improvement of Severity