Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04490109
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2020-07-16
Brief Title:
B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis
Sponsor:
AOBiome LLC
Organization:
AOBiome LLC
Study Overview
Official Title:
A Phase II Randomized Double-Blind Vehicle Controlled Study of the Efficacy Safety and Tolerability of B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a double-blind randomized vehicle-controlled study to assess the efficacy safety and tolerability of 2 doses of B244 for the treatment of pruritus in adults with a history of atopic dermatitis Subjects who meet the study entry criteria will be randomized in a 111 ratio to receive twice daily topical doses of B244 OD 50 B244 OD 200 or vehicle placebo for 4 weeks
Detailed Description:
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 inclusionexclusion 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 111 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 OD 50 or OD 200
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 ie 10 pumps in the morning and 10 pumps again at night for 4 weeks
Safety evaluations will consist of review of participants medical history at screening and on-going assessment of adverse events reported throughout the study duration
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 inclusionexclusion 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 111 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 OD 50 or OD 200
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 ie 10 pumps in the morning and 10 pumps again at night for 4 weeks
Safety evaluations will consist of review of participants medical history at screening and on-going assessment of adverse events reported throughout the study duration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None