Trials / Completed
CompletedNCT03590366
A Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Rosacea
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- AOBiome LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | B244 | B244 Suspension |
| BIOLOGICAL | Vehicle | Vehicle suspension |
Timeline
- Start date
- 2018-07-02
- Primary completion
- 2019-02-11
- Completion
- 2019-03-05
- First posted
- 2018-07-18
- Last updated
- 2022-09-16
- Results posted
- 2022-09-16
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03590366. Inclusion in this directory is not an endorsement.