Status and phase
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Treatments
About
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).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Be a female ≥18 years of age
At Screening visit, have at least 1 quadrant with:
At Day 1 visit, have an assigned quadrant with:
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:
Primary purpose
Allocation
Interventional model
Masking
375 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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