Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
AOBiome LLC
With
This is a Prospective, Vehicle Controlled, Double-Blind, Multicenter, Randomized Phase II Trial, comparing the effect of twice daily B244 applications for 4 weeks vs vehicle applications on treatment of mild to moderate pruritus associated with atopic dermatitis. * Approximately 576 subjects may be enrolled. * The total duration of the study will be approximately 11 weeks. Participants will report for a Screening visit and if all inclusion/exclusion criteria are met, subjects will go through a two-week washout phase before reporting for a Baseline visit. * After screening and baseline, participants will be randomized to one of two doses of B244 or vehicle application for 4 weeks. * Randomization will be 1:1:1 so that an equal number of patients will be treated in each Arm of the study. * All B244 randomized subjects will be treated at the dose of O.D. 5.0 or O.D. 20.0 * Subjects must be willing and able to complete diary within a consistent time frame on a daily basis and to comply with restrictions on allowable therapies for the duration of the study. * All subjects will attend a screening visit not more than 21 days prior to Baseline (Day 0). * Subjects will be required to return to the clinic at Baseline, Day 14 (Week 2) and Day 28 (Week 4) visits. All subjects will be asked to attend a Week 8 follow-up visit 4 weeks (28 (±3) days) after the last dose of study medication. * Subjects will apply a total of 10 pumps of IP per application across all affected areas twice-a-day (i.e. 10 pumps in the morning and 10 pumps again at night) for 4 weeks. * Safety evaluations will consist of review of participant's medical history at screening and on-going assessment of adverse events reported throughout the study duration.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
