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This is a 12-week, multicenter, double-blind, randomized, two-arm, vehicle controlled study. Subjects will be randomized 1:1 to BPX-04 minocycline topical gel 1% or vehicle. This study will include approximately 176 randomized subjects with inflammatory lesions of papulopustular rosacea on the face, defined by an IGA score of 3 (moderate) or 4 (severe) at Baseline. Subjects will be healthy male or female subjects aged 18 years or older. There will be up to 20 study sites in the USA.
This is a 12-week, multicenter, double-blind, randomized, two-arm, vehicle controlled study. Subjects will be randomized 1:1 to BPX-04 minocycline topical gel 1% or vehicle. This study will include approximately 176 randomized subjects with inflammatory lesions of papulopustular rosacea on the face, defined by an IGA score of 3 (moderate) or 4 (severe) at Baseline. Subjects will be healthy male or female subjects aged 18 years or older. There will be up to 20 study sites in the USA.
Subjects will apply approximately 1 gram of topical gel once each day for a 12 week duration. They will come to the study site at Screening, Baseline, and Weeks 4, 8, and 12 or early termination (ET) for the protocol required efficacy and safety evaluations.
At each visit, efficacy will be assessed by rosacea lesion counts, IGA, PGI-S, PGI-I, CGI-S, CGI-I, RosaQoL, Erythema Assessment Scale, Telangiectasia Assessment Scale and subject satisfaction questionnaire.
Safety will be assessed with vital signs, physical examination, laboratory tests such as clinical hematology and chemistries, investigators' and subjects' assessments of cutaneous tolerability, incidence of minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri, and incidence of TEAEs. Blood samples will be collected to evaluate the level of minocycline in plasma at Baseline and Week 12/ET.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPX-04 Active | Experimental | BPX-04 1% minocycline topical gel |
|
| BPX-04 Vehicle | Placebo Comparator | BPX-04 topical gel vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| minocycline topical gel | Drug | Once daily administration of BPX-04 minocycline gel for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory lesion count | Change in mean facial inflammatory lesion count | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IGA | Proportion of subjects with ≥2-point change in IGA of rosacea to clear or almost clear | Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AnnaMarie Daniels | BioPharmX, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Center | Anaheim Hills | California | 92807 | United States | ||
| Study Center |
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Vehicle control is identical to the active product in appearance
| topical gel vehicle | Drug | Once daily administration of BPX-04 gel vehicle for 12 weeks |
|
| Miami |
| Florida |
| 33175 |
| United States |
| Study Center | Miramar | Florida | 33027 | United States |
| Study Center | Baton Rouge | Louisiana | 70809 | United States |
| Study Center | New Orleans | Louisiana | 70115 | United States |
| Study Center | Needham | Massachusetts | 02135 | United States |
| Study Center | Saint Joseph | Missouri | 64506 | United States |
| Study Center | Morristown | New Jersey | 07960 | United States |
| Study Center | High Point | North Carolina | 27262 | United States |
| Study Center | Philadelphia | Pennsylvania | 19103 | United States |
| Study Center | Austin | Texas | 78759 | United States |
| Study Center | San Antonio | Texas | 78213 | United States |
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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