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

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ClinicalTrials.gov Identifier: NCT03752242
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
BioMimetix JV, LLC

Tracking Information
First Submitted Date  ICMJE November 15, 2018
First Posted Date  ICMJE November 22, 2018
Last Update Posted Date January 7, 2019
Actual Study Start Date  ICMJE January 3, 2019
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2018)
  • Determine whether the optimum frequency of topical application of BMX-010 0.03% is once per day or twice per day for a treatment interval of 7 to 28 days. [ Time Frame: 28 days ]
    Assessed by change in the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28.
  • Determine whether the optimum frequency of topical application of BMX-010 0.1% is once per day or twice per day for a treatment interval of 7 to 28 days. [ Time Frame: 28 days ]
    Assessed by change in the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28.
  • Determine if BMX-010 cream or gel provides better efficacy in the clearing of acne. [ Time Frame: 43 days ]
    Assessed by change in the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28, followed by a final assessment two weeks after dosing ends at day 43.
  • Evaluate the efficacy of BMX-010 in treatment of Acne Vulgaris. [ Time Frame: 43 days ]
    Assessed by change in the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28, followed by a final assessment two weeks after dosing ends at day 43.
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2018)
  • Determine whether the optimum frequency of topical application of BMX-010 0.03% is once per day or twice per day for a treatment interval of 7 to 28 days. [ Time Frame: 28 days ]
    Assessed by the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28.
  • Determine whether the optimum frequency of topical application of BMX-010 0.1% is once per day or twice per day for a treatment interval of 7 to 28 days. [ Time Frame: 28 days ]
    Assessed by by the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28.
  • Determine if BMX-010 cream or gel provides better efficacy in the clearing of acne. [ Time Frame: 43 days ]
    Assessed by the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28, followed by a final assessment two weeks after dosing ends at day 43.
  • Evaluate the efficacy of BMX-010 in treatment of Acne Vulgaris. [ Time Frame: 43 days ]
    Assessed by the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28, followed by a final assessment two weeks after dosing ends at day 43.
Change History Complete list of historical versions of study NCT03752242 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2018)
  • Document, as possible, the clinical effects of BMX-010 in subjects with Acne Vulgaris through clinical photography. [ Time Frame: 43 days ]
    If consented by the patient, photos will be taken at each study visit.
  • Assess the mean percent reduction change in inflammatory and noninflammatory lesion counts from baseline to end of study. [ Time Frame: 43 days ]
    Inflammatory and non-inflammatory lesions will be counted at each study visit.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Topical Application of BMX-010 in Subjects With Acne Vulgaris.
Official Title  ICMJE An Exploratory Trial to Evaluate the Clinical Effectiveness of a Topical Application of BMX-010 in Subjects With Acne Vulgaris.
Brief 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
In Part A, all subjects will receive study drug and this is Open Label. When Part A is complete, Part B will start and this will be double blind to participant and investigators.
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE Drug: BMX-010
Safety and efficacy of BMX-010 in topical treatment of acne.
Study Arms  ICMJE
  • Experimental: BMX-010 0.03%
    Approximately 30 subjects will receive BMX-010 0.03% for 7-28 days to be applied topically to Acne of the face.
    Intervention: Drug: BMX-010
  • Experimental: BMX-010 0.1%
    Approximately 30 subjects will receive BMX-010 0.1% for 7-28 days to be applied topically to Acne of the face.
    Intervention: Drug: BMX-010
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sara Penchev 720-613-4872 contact@bmxpharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03752242
Other Study ID Numbers  ICMJE BMX-DERM-203
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party BioMimetix JV, LLC
Study Sponsor  ICMJE BioMimetix JV, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BioMimetix JV, LLC
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP