Evaluation of Topical Application of BMX-010 in Subjects With Acne Vulgaris.
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: BMX-010 0.3%
Intervention description: Safety and efficacy of BMX-010 in topical treatment of acne.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: In Part A, all subjects will receive study drug and this is Open Label.
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an exploratory Phase 2 trial of BMX-010 in patients with Acne Vulgaris which will be
      conducted in two parts.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, at least 18 years of age;

          2. A clinical diagnosis of mild to severe facial Acne Vulgaris; Subjects may also have
             acne at other body sites;

          3. Screening and Baseline IGA score > 2 (greater than or equal to 2);

          4. Willing to refrain from using any topical or systemic treatments for inflammatory skin
             disease, other than the investigational product;

          5. Candidate for topical treatment of Acne;

          6. 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.

          7. Females of child-bearing potential must have a negative urine pregnancy test within 48
             hours prior to the first drug administration;

          8. 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;

          9. Ability to complete the study in compliance with the protocol, including agreement in
             writing to apply study product only to the assigned areas; and

         10. Ability to understand and provide written informed consent.

        Exclusion Criteria:

          1. 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;

          2. Use of androgen receptor blockers (such as spironolactone or flutamide);

          3. Severe cystic acne, acne conglobate, acne fulminans, or secondary acne;

          4. Use of phototherapy devices, energy-based devices, adhesive cleansing strips, or
             cosmetic procedures (e.g., facials, peeling, comedo extraction) in the past week;

          5. 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;

          6. Prior or current concomitant therapies that would interfere with assessments in the
             study;

          7. Subjects with any underlying disease that the Investigator deems uncontrolled, and
             poses a concern for the subject's safety while participating in the study;

          8. Use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics,
             antibacterials (including benzoyl peroxide-containing products [e.g., benzamycin]),
             retinoids; other topical acne treatments (e.g., photodynamic therapy, medicated soaps
             such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium
             sulfacetamide) in the past 2 weeks;

          9. Oral retinoid use (e.g., isotretinoin) within 6 months prior to baseline or vitamin A
             supplements greater than 10,000 units/day within 6 months of baseline;

         10. Concomitant skin disease that could confound clinical evaluations or increase risk to
             the subject;

         11. Use of medicated make-up (including anti-aging make-up) throughout the study;

         12. Use during the study of 1) systemic steroids, 2) topical retinoids to the face, 3)
             antibiotics known to impact acne, 4) immunosuppressive agents, or immunomodulators;

         13. Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical
             antimycotics, 4) any topical acne treatments or 4) topical antibiotics;

         14. Use of medicated cleansers on the face (throughout the study);

         15. Use of topical astringents or abrasives, medical topical preparations (prescription
             and OTC products) within 2 days prior to Baseline and throughout the study;

         16. Systemic or skin infection requiring antimicrobial therapy;

         17. Systemic chemotherapy or radiotherapy within 4 weeks of the Baseline Visit;

         18. Immunocompromise of any cause, known human immunodeficiency virus infection, or
             acquired immunodeficiency syndrome;

         19. Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the
             investigator;

         20. Active drug or alcohol dependence;

         21. 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;

         22. Previous clinical trial participation for the indication being treated in this
             protocol.