Evaluation of Topical Application of BMX-010 in Subjects With Acne Vulgaris.

• Status: Terminated
• Trial end date: 2020-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This is an exploratory Phase 2 trial of BMX-010 in patients with Acne Vulgaris which will be conducted in two parts. Up to 210 subjects with Acne Vulgaris will be enrolled.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioMimetix JV, LLC

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.