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

• Status: Active, not recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

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.

• 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 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.