This is a double-blind, randomized, placebo-controlled, crossover trial, to test the hypothesis that RDD1609 is effective in treating idiopathic pruritus ani.
This is a phase 2a randomized double-blinded placebo-controlled cross-over design study in patients with idiopathic pruritus ani. 24 patients, male and females, aged 18 -65 with severe idiopathic pruritus ani (VAS score above 60), will be randomized to this study. Patients that meet all inclusion criteria and do not have exclusion criteria at randomization visit will be randomly assigned to one of the two treatment groups: Group 1 will receive 3 weeks of RDD1609 for 3 weeks, followed by 3 weeks of treatment with placebo. Group 2 will receive 3 weeks of treatment with placebo followed by 3 weeks of treatment with RDD1609.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
RDD1609 to be applied on the perianal area BID
Mebendazole 100 mg single dose (single prophylactic dose of the anthelmintic medicine)
The Atherstone Surgery
Atherstone, United Kingdom
University Hospitals Bristol NHS Foundation Trust- Location Bristol Royal Infirmary
Bristol, United Kingdom
Kings Medical Centre
Buckhurst Hill, United Kingdom
Sheepcot Medical Centre
Watford, United Kingdom
Visual Analogue Scale (VAS) for itching
Change in severity of itch, measured using Visual Analogue Scale score for itching from baseline through the end of treatment. The Visual Analogue Scale is a 10-cm long line (oriented horizontally), on which patients indicate the severity of their itching by crossing the line at the point that corresponded to their itching severity. The left end of the line indicates "no itch" and right end of the line indicates "worth itch ever".
Time frame: 3 weeks
Pruritus Ani Severity Index score
Effect of RDD1609 on the Pruritus Ani Severity Index score (Mild, Moderate, Severe, Chronic), which is a grading system used to describe severity of physical findings in patients with pruritus ani.
Time frame: 3 weeks
Safety and Tolerability of RDD1609 ( the frequency of adverse events and serious adverse events)
Will be based primarily on the frequency of adverse events and serious adverse events. Other safety data will be summarized as appropriate.
Time frame: 3 weeks
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