Status:
SUSPENDED
Evaluation of Topical Application of BMX-010 in Subjects With Rosacea
Lead Sponsor:
BioMimetix JV, LLC
Conditions:
Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Part A is designed to confirm the optimal formulation, strength, and dosing frequency of the study drug. Up to 60 subjects will be enrolled in this part. Part B is designed to be a randomized, double...
Eligibility Criteria
Inclusion
- Male or female, at least 18 years of age;
- A clinical diagnosis of mild to severe facial rosacea;
- Screening and Baseline IGA score \> 2 (greater than or equal to 2);
- A minimum Clinician Erythema Assessment (CEA) score of 2 at Screening and at Baseline Visits (prior to the investigational product application);
- Willing to refrain from using any topical or systemic treatments for inflammatory skin disease, other than the investigational product;
- Candidate for topical treatment of Rosacea;
- 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;
- Females of child-bearing potential must have a negative urine pregnancy test within 48 hours prior to the first drug administration;
- 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;
- Ability to complete the study in compliance with the protocol, including agreement in writing to apply study product only to the assigned areas; and
- Ability to understand and provide written informed consent.
Exclusion
- Any dermatological conditions on the face that could interfere with clinical evaluations;
- 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;
- 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;
- Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study;
- Concomitant skin disease that could confound clinical evaluations or increase risk to the subject;
- Use of medicated make-up (including anti-aging make-up) throughout the study;
- 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;
- Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical antimycotics, 4) any topical rosacea treatments or 4) topical antibiotics;
- Use of medicated cleansers on the face (throughout the study);
- Use of topical astringents or abrasives, medical topical preparations (prescription and OTC products) within 2 days prior to Baseline and throughout the study;
- Systemic or skin infection requiring antimicrobial therapy;
- Systemic chemotherapy or radiotherapy within 4 weeks of the Baseline Visit;
- Immunocompromise of any cause, known human immunodeficiency virus infection, or acquired immunodeficiency syndrome;
- Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the investigator;
- Active drug or alcohol dependence;
- 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;
- Previous clinical trial participation for the indication being treated in this protocol.
Key Trial Info
Start Date :
January 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03756389
Start Date
January 3 2018
End Date
March 1 2025
Last Update
September 28 2022
Active Locations (1)
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1
Colorado Skin Care
Englewood, Colorado, United States, 80113