This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of up to 2 treatments of EN3835 vs placebo in participants with plantar fibromatosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
176
Change From Baseline to Day 57 in the Foot Function Index (FFI) Pain Subscale Score
FFI pain subscale consisted of 9 items which were scored on a scale of 0 ("None") to 4 ("Extreme") with a total score ranging from 0 to 36. Lower scores indicated better foot function, while higher scores reflected greater impairment.
Time frame: Baseline (Day 1), Day 57
Change From Baseline to Day 57 in the FFI Total Combined (Pain and Difficulty) Score
The FFI pain subscale consisted of 9 items which were scored on a scale of 0 ("None") to 4 ("Extreme") with a total score ranging from 0 to 36. The FFI difficulty subscale consisted of 9 items which were scored on a scale of 0 ("No difficulty") to 4 ("A lot of difficulty") with a total score ranging from 0 to 36. The Total Combined score of pain and difficulty comprised scores of answered items in each subscale with a maximum total score range of 0 to 72. Lower scores indicated better foot function, while higher scores reflected greater impairment.
Time frame: Baseline (Day 1), Day 57
Percentage of Participants With a Response of "Minimal Improvement", "Much Improvement" or "Very Much Improvement" (Responders) in the Clinician Global Impression of Change Scale
The responder (by foot/feet) was defined as a participant with a response of "Minimal Improvement", "Much Improvement" or "Very Much Improvement" in the CGIC Scale. All participants who withdrew early from the study were considered as non-responders. If participant was treated for both feet, then the assessment could be combined at participant level using worst case approach, if one foot response was recorded as 'Minimal Improvement' and 'Very Much Improvement' in another foot, then response was considered as 'Minimal Improvement'.
Time frame: Day 57
Change From Baseline to Day 57 in the Nodular Hardness of the Treated Nodules by Durometer Measurement
A durometer was used to measure the hardness of treated nodules, on a scale ranging from 0 to 100. Higher scores indicated a greater hardness.
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Endo Clinical Trial Site #29
Mesa, Arizona, United States
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Tucson, Arizona, United States
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Bakersfield, California, United States
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Encinitas, California, United States
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Fresno, California, United States
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La Mesa, California, United States
Endo Clinical Trial Site #30
Los Angeles, California, United States
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Tarzana, California, United States
Endo Clinical Trial Site #36
Torrance, California, United States
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Vista, California, United States
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Time frame: Baseline (Day 1), Day 57