Evaluation of Topical Application of BMX-010 in Subjects With Rosacea

Study Overview
=================
Brief Summary
-----------------
This is an exploratory Phase 2 trial of BMX-010 in patients with Rosacea which will be conducted in two parts. Up to 210 subjects with Rosacea will be enrolled.

Detailed Description
-----------------
Part A is designed to confirm the optimal formulation, strength, and dosing frequency of the study drug. Up to 60 subjects will be enrolled in this part. Part B is designed to be a randomized, double-blind trial studying the optimal formulation, strength, and dosing frequency of BMX-010 as determined in Part A, compared to Placebo. Up to 150 subjects will be enrolled in this part. In both parts, adult subjects with Rosacea will be enrolled.

Official Title
-----------------
An Exploratory Trial to Evaluate the Clinical Effectiveness of a Topical Application of BMX-010 in Subjects With Rosacea

Conditions
-----------------
Rosacea

Intervention / Treatment
-----------------
* Drug: BMX-010


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, at least 18 years of age; A clinical diagnosis of mild to severe facial rosacea; Screening and Baseline IGA score > 2 (greater than or equal to 2); A minimum Clinician Erythema Assessment (CEA) score of 2 at Screening and at Baseline Visits (prior to the investigational product application); Willing to refrain from using any topical or systemic treatments for inflammatory skin disease, other than the investigational product; Candidate for topical treatment of Rosacea; If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the subject wears makeup they must agree to use non-comedogenic makeup; Females of child-bearing potential must have a negative urine pregnancy test within 48 hours prior to the first drug administration; Females of child-bearing potential must be willing to use 2 methods of contraception deemed adequate by the investigator (for example, oral contraceptive pills plus a barrier method) through the trial and for 1 month thereafter to be eligible for, and continue participation in, the study; Ability to complete the study in compliance with the protocol, including agreement in writing to apply study product only to the assigned areas; and Ability to understand and provide written informed consent. Exclusion Criteria: Any dermatological conditions on the face that could interfere with clinical evaluations; Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive; 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; Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study; Concomitant skin disease that could confound clinical evaluations or increase risk to the subject; Use of medicated make-up (including anti-aging make-up) throughout the study; Use during the study of 1) systemic steroids, 2) topical retinoids to the face, 3) antibiotics known to impact rosacea, 4) immunosuppressive agents, or immunomodulators; Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical antimycotics, 4) any topical rosacea treatments or 4) topical antibiotics; Use of medicated cleansers on the face (throughout the study); Use of topical astringents or abrasives, medical topical preparations (prescription and OTC products) within 2 days prior to Baseline and throughout the study; Systemic or skin infection requiring antimicrobial therapy; Systemic chemotherapy or radiotherapy within 4 weeks of the Baseline Visit; Immunocompromise of any cause, known human immunodeficiency virus infection, or acquired immunodeficiency syndrome; Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the investigator; Active drug or alcohol dependence; Significant acute or chronic medical, neurological, or psychiatric illness that, in the judgment of the investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study; Previous clinical trial participation for the indication being treated in this protocol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMX-010 0.03%<br>Approximately 30 subjects will receive BMX-010 0.03% for 7-28 days to be applied topically to Rosacea of the face. | Drug: BMX-010<br>* Safety and efficacy of BMX-010 in topical treatment of rosacea.<br>|
| Experimental: BMX-010 0.1%<br>Approximately 30 subjects will receive BMX-010 0.1% for 7-28 days to be applied topically to Rosacea of the face. | Drug: BMX-010<br>* Safety and efficacy of BMX-010 in topical treatment of rosacea.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine whether the optimum frequency of topical application of BMX-010 0.03% is once per day or twice per day for a treatment interval of up to 28 days. | Assessed by number of participants with a change in Investigator Global Assessment (IGA) grade which will be assessed weekly. | 28 days | 
| Determine whether the optimum frequency of topical application of BMX-010 0.03% is once per day or twice per day for a treatment interval of up to 28 days. | Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade which will be assessed weekly. | 28 days | 
| Determine whether the optimum frequency of topical application of BMX-010 0.1% is once per day or twice per day for a treatment interval of up to 28 days. | Assessed by number of participants with a change in Investigator Global Assessment (IGA) grade which will be assessed weekly. | 28 days | 
| Determine whether the optimum frequency of topical application of BMX-010 0.1% is once per day or twice per day for a treatment interval of up to 28 days. | Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade which will be assessed weekly. | 28 days | 
| Determine if BMX-010 cream or gel provides better efficacy in the treatment of rosacea. | Assessed by number of participants with a change in Investigator Global Assessment (IGA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43). | 43 days | 
| Determine if BMX-010 cream or gel provides better efficacy in the treatment of the redness of rosacea. | Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43). | 43 days | 
| Evaluate the efficacy of BMX-010 in treatment of rosacea. | Assessed by number of participants with a change in Investigator Global Assessment (IGA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43). | 43 days | 
| Evaluate the effect of BMX-010 on redness in patients with rosacea. | Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43). | 43 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Document, as possible, the clinical effects of BMX-010 in subjects with Rosacea through clinical photography. | If consented by the patient, photos will be taken at each study visit. | 43 days | 
| Assess the mean percent reduction change in inflammatory papules/pustules counts from baseline to end of study. | Inflammatory lesions will be counted at each study visit. | 43 days |