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



Status:Recruiting
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:1/9/2019
Start Date:January 3, 2019
End Date:November 2022
Contact:Sara Penchev
Email:contact@bmxpharma.com
Phone:720-613-4872

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An Exploratory Trial to Evaluate the Clinical Effectiveness of a Topical Application of BMX-010 in Subjects With Acne Vulgaris.

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.

Part A is designed to confirm the optimal formulation, strength, and dosing frequency of the
study drug in patients with Acne. 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 in
patients with Acne. 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 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.
We found this trial at
1
site
3701 South Clarkson Street
Englewood, Colorado 80113
Phone: 303-740-4883
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Englewood, CO
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