Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-03 @ 11:12 PM
Study NCT ID:
NCT03590366
Status:
COMPLETED
Last Update Posted:
2022-09-16
First Post:
2018-06-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Rosacea
Sponsor:
AOBiome LLC
Organization:
Study Overview
Official Title:
A Vehicle-Controlled, Double-Blind, Randomized Phase II Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Mild to Moderate Rosacea
Status:
COMPLETED
Status Verified Date:
2022-08
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 Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 8 weeks vs. vehicle application on treatment of mild to moderate rosacea.
Detailed Description:
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 8 weeks vs. vehicle application on treatment of mild to moderate rosacea.
At Screening and Baseline all subjects must have Type 1 erythematotelangiectatic rosacea (ETR).
The total duration of the study will be approximately 12 weeks. Participants will report for a Screening visit and if all inclusion criteria are met will undergo a washout period, between 2 days and 4 weeks, depending on current treatment. Subjects will then report for the Baseline visit.
Subjects will come in for visits at Day 7 (Week 1), Day 28 (Week 4), and Day 56 (Week 8). A final visit will be conducted at Day 84 (Week 12).
Efficacy will be assessed using Clinician Erythema Assessment (CEA), Investigator Global Assessment (IGA), Skindex16, and Patient Self-Assessment (PSA).
Blood and urine samples will be collected for standard safety laboratory tests. Participant's safety will be monitored throughout the study.
Investigators plan to enroll approximately 130 subjects.
Randomization will be 1:1 so that equal numbers of subjects will be treated in each arm of the study.
At Screening and Baseline all subjects must have Type 1 erythematotelangiectatic rosacea (ETR).
The total duration of the study will be approximately 12 weeks. Participants will report for a Screening visit and if all inclusion criteria are met will undergo a washout period, between 2 days and 4 weeks, depending on current treatment. Subjects will then report for the Baseline visit.
Subjects will come in for visits at Day 7 (Week 1), Day 28 (Week 4), and Day 56 (Week 8). A final visit will be conducted at Day 84 (Week 12).
Efficacy will be assessed using Clinician Erythema Assessment (CEA), Investigator Global Assessment (IGA), Skindex16, and Patient Self-Assessment (PSA).
Blood and urine samples will be collected for standard safety laboratory tests. Participant's safety will be monitored throughout the study.
Investigators plan to enroll approximately 130 subjects.
Randomization will be 1:1 so that equal numbers of subjects will be treated in each arm of the study.
Study Oversight
Has Oversight DMC:
False
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?: