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

NCT03756389 | Suspended Phase 2 FDA Drug

• 1 other identifier: BMX-DERM-202
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Rosacea

Outcome Measures

Primary Outcomes (8)

• 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 up to 28 days.

  Assessed by number of participants with a change in Investigator Global Assessment (IGA) grade which will be assessed weekly.

  28 days

• 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 up to 28 days.

  Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade which will be assessed weekly.

  28 days

• 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 up to 28 days.

  Assessed by number of participants with a change in Investigator Global Assessment (IGA) grade which will be assessed weekly.

  28 days

• 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 up to 28 days.

  Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade which will be assessed weekly.

  28 days

• Determine if BMX-010 cream or gel provides better efficacy in the treatment of rosacea.

  Assessed by number of participants with a change in Investigator Global Assessment (IGA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43).

  43 days

• Determine if BMX-010 cream or gel provides better efficacy in the treatment of the redness of rosacea.

  Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43).

  43 days

• Evaluate the efficacy of BMX-010 in treatment of rosacea.

  Assessed by number of participants with a change in Investigator Global Assessment (IGA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43).

  43 days

• Evaluate the effect of BMX-010 on redness in patients with rosacea.

  Assessed by number of participants with a change in Clinical Erythema Assessment (CEA) grade. This will be assessed weekly with a final assessment two weeks after dosing ends (Day 43).

  43 days

Secondary Outcomes (2)

• Document, as possible, the clinical effects of BMX-010 in subjects with Rosacea through clinical photography.

  43 days

• Assess the mean percent reduction change in inflammatory papules/pustules counts from baseline to end of study.

  43 days

Study Arms (2)

BMX-010 0.03%

EXPERIMENTAL

Approximately 30 subjects will receive BMX-010 0.03% for 7-28 days to be applied topically to Rosacea of the face.

Drug: BMX-010

BMX-010 0.1%

EXPERIMENTAL

Approximately 30 subjects will receive BMX-010 0.1% for 7-28 days to be applied topically to Rosacea of the face.

Drug: BMX-010

Interventions

BMX-010 DRUG

Safety and efficacy of BMX-010 in topical treatment of rosacea.

BMX-010 0.03%; BMX-010 0.1%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• BioMimetix JV, LLC: lead

Study Sites (1)

Colorado Skin Care

Englewood, Colorado, 80113, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 28, 2018
• Study Start: January 3, 2018
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

US (1)