A Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Rosacea

Completed · Phase 2

Conditions studied: Rosacea

In brief

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.

Key facts

Study ID

NCT03590366

Run by

AOBiome LLC

People needed

140

Starts

2018-07-02

Expected to finish

2019-03-05

Last updated by the study team

2022-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects ≥18.
• A clinical diagnosis of mild to moderate facial rosacea.
• In good general health as determined by a thorough medical history, physical examination, clinical chemistry and hematology.
• Presence of 3 to 20 inflammatory lesions on the face (i.e. papules/pustules).
• A Clinician Erythema Assessment (CEA) score of 2-3 at Screening and at Baseline Visits (prior to the investigational product application).
• Mild to Moderate IGA score of 2-3 at Screening and at Baseline Visits (prior to the investigational product application).
• Willing to refrain from using any topical or systemic treatments for the treatment of rosacea, other than the investigational product.
• Females of childbearing potential with a negative urine pregnancy test (UPT) at Screening and Baseline/Day 1 (prior to the investigational product application).
• Ability to comprehend and comply with study procedures.
• Agree to commit to participate in the current protocol.
• Provide written informed consent prior to any study procedure being performed.

You may not qualify if…

• Female subjects who are pregnant, lactating or who are trying to conceive will be excluded from participation in this study.
• Any uncontrolled chronic or serious disease or medical condition that would normally prevent participation in a clinical trial, or, in the judgment of the Investigator, would put the subject at undue risk, or might confound the study assessments (e.g., other dermatological diseases), or might interfere with the subject's participation in the study, (e.g., planned hospitalization during the study).
• Particular forms of rosacea (e.g., rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin, Ocular rosacea Phymatous rosacea, Steroid-induced rosacea, severe rosacea including pyoderma faciale) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
• Presence of more than two (2) nodulocystic lesions on the face.
• Presence of less than 3 and more than 20 inflammatory lesions on the face (i.e. papules/pustules).
• Severe papulopustular rosacea requiring systemic treatment.
• Participation at the time of eligibility assessment (Screening) in any other investigational drug or device study or may have participated within 30 days prior to Screening.
• Commencement of new hormonal therapy or dose change to hormonal therapy within 30 days prior to baseline. Dose and frequency of use of any hormonal therapy started more than 30 days prior to baseline must remain unchanged throughout the study. Hormonal therapies include, but are not limited to, oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (e.g. vaginal ring or transdermal hormone contraception)
• Presence of beard or excessive facial hair at Screening which would interfere with the study treatments or study assessments and refusal to remove for duration of study.
• Carcinoid, Pheochromocytoma or other systemic causes of flushing.
• Known sensitivity to B244 or its components.
• Refusal to submit to blood and urine sampling for laboratory analysis.
• Treatment with prohibited medications.

Where it is running

• Tampa Bay Medical Research — Clearwater, Florida, United States
• Veritas Research Corp — Miami, Florida, United States
• South Coast Research Center, Inc. — Miami, Florida, United States
• FXM Research Corp. — Miami, Florida, United States
• FXM Research Miramar — Miramar, Florida, United States
• Wake Research Associates, LLC — Raleigh, North Carolina, United States
• Paddington Testing Co. — Philadelphia, Pennsylvania, United States
• Omega Medical Research — Warwick, Rhode Island, United States
• West Houston Clinical Research Service — Houston, Texas, United States

Full record on ClinicalTrials.gov

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