A Phase 2, Randomized, Double-blind, Placebo Controlled Dose Ranging Study of Repeat Doses of AA4… (NCT01987986) | Clinical Trial Compass
CompletedPhase 2
A Phase 2, Randomized, Double-blind, Placebo Controlled Dose Ranging Study of Repeat Doses of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy
United States150 participantsStarted 2013-10
Plain-language summary
To assess the safety and effectiveness of repeat doses of AA4500 in the treatment of edematous fibrosclerotic panniculopathy (EFP) commonly known as cellulite in adult women.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. Be a female between 18 to 45 years of age.
✓. Have at least one well defined dimple that is at least 1 cm but not more than 2 cm along the long axis and that is evident when the subject is standing
✓. Have a photonumeric cellulite severity scale (CSS) score between 6 and 12
✓. Have a Body Mass Index (BMI) \>19 and \<30 kg/m2, and intends to maintain stable body weight throughout the duration of the study
✓. Be willing to apply appropriate sunscreen to the selected quadrant before each exposure to the sun while participating in the 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 before injection of AA4500 and be using an effective contraception method (ie, abstinence, intrauterine device \[IUD\], hormonal \[estrogen/progestin\] contraceptives, or barrier control) for at least one menstrual cycle prior to study enrollment and for the duration of the study.
✓. Be willing and able to cooperate with the requirements of the study.
Exclusion criteria
✕. Thyroid disease, unless controlled with medication for ≥ 6 months
✕. Uncontrolled diabetes mellitus, as determined by the investigator
✕. Uncontrolled hypertension, as determined by the investigator
What they're measuring
1
Investigator Global Assessment of Aesthetic Improvement