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

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.

Inclusion Criteria:

1. Male or female, at least 18 years of age;

2. A clinical diagnosis of mild to severe facial rosacea;

3. Screening and Baseline IGA score > 2 (greater than or equal to 2);

4. A minimum Clinician Erythema Assessment (CEA) score of 2 at Screening and at Baseline
Visits (prior to the investigational product application);

5. Willing to refrain from using any topical or systemic treatments for inflammatory skin
disease, other than the investigational product;

6. Candidate for topical treatment of Rosacea;

7. 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;

8. Females of child-bearing potential must have a negative urine pregnancy test within 48
hours prior to the first drug administration;

9. 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;

10. Ability to complete the study in compliance with the protocol, including agreement in
writing to apply study product only to the assigned areas; and

11. Ability to understand and provide written informed consent.

Exclusion Criteria:

1. Any dermatological conditions on the face that could interfere with clinical
evaluations;

2. 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;

3. 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;

4. Subjects with any underlying disease that the Investigator deems uncontrolled, and
poses a concern for the subject's safety while participating in the study;

5. Concomitant skin disease that could confound clinical evaluations or increase risk to
the subject;

6. Use of medicated make-up (including anti-aging make-up) throughout the study;

7. 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;

8. Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical
antimycotics, 4) any topical rosacea treatments or 4) topical antibiotics;

9. Use of medicated cleansers on the face (throughout the study);

10. Use of topical astringents or abrasives, medical topical preparations (prescription
and OTC products) within 2 days prior to Baseline and throughout the study;

11. Systemic or skin infection requiring antimicrobial therapy;

12. Systemic chemotherapy or radiotherapy within 4 weeks of the Baseline Visit;

13. Immunocompromise of any cause, known human immunodeficiency virus infection, or
acquired immunodeficiency syndrome;

14. Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the
investigator;

15. Active drug or alcohol dependence;

16. 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;

17. Previous clinical trial participation for the indication being treated in this
protocol.