Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2026-03-08 @ 4:26 AM
Study NCT ID:
NCT02815332
Status:
COMPLETED
Last Update Posted:
2017-04-14
First Post:
2016-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BPX-01 Minocycline Topical Gel in the Treatment of Acne Vulgaris
Sponsor:
BioPharmX, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Vehicle Controlled Study to Assess the Safety and Efficacy of BPX-01 Minocycline Topical Gel in the Treatment of Moderate to Severe Inflammatory Acne Vulgaris
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPAL
Brief Summary:
This is a 12-week, multi-center, double-blind, randomized, three-arm, vehicle-controlled study.
Subjects will be randomized (1:1:1) to 1% or 2 % BPX-01 gel, or vehicle. Subjects will apply 1g of the gel as a thin film to the entire face at least 30 minutes before bedtime each night for 12 weeks. Lesion counts, IGA, and Patient-Reported Outcomes (PGI-S and PGI-I) will be performed to assess efficacy.
Blood draws will be collected at baseline (Day 0), and at Weeks 4 and 12 to evaluate the level of minocycline in plasma. Safety will be assessed with the vital signs, brief physical examination, clinical laboratory tests, cutaneous tolerance score, incidence of minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri, and collection of adverse events.
Subjects will be randomized (1:1:1) to 1% or 2 % BPX-01 gel, or vehicle. Subjects will apply 1g of the gel as a thin film to the entire face at least 30 minutes before bedtime each night for 12 weeks. Lesion counts, IGA, and Patient-Reported Outcomes (PGI-S and PGI-I) will be performed to assess efficacy.
Blood draws will be collected at baseline (Day 0), and at Weeks 4 and 12 to evaluate the level of minocycline in plasma. Safety will be assessed with the vital signs, brief physical examination, clinical laboratory tests, cutaneous tolerance score, incidence of minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri, and collection of adverse events.
Detailed Description:
This is a phase 2b, randomized, double-blind, vehicle-controlled study to Assess the Safety and Efficacy of BPX-01 Minocycline Topical Gel in the Treatment of Moderate to Severe Inflammatory Acne Vulgaris.
Study Population: Approximately 225 male or female subjects aged between 9 and 40 years with moderate to severe inflammatory non-nodular acne vulgaris will be included in this study.
Number of Sites: Approximately 15 centers from the United States will participate in this study.
Study Duration: Overall study duration is expected to be approximately 24 weeks (6 months). The study duration for individual subjects is approximately 16 weeks (including the screening period).
Hypothesis: BPX-01 improves disease condition in subjects with moderate to severe inflammatory non-nodular acne vulgaris compared with vehicle.
Objectives:
Primary:
* To evaluate the efficacy of BPX-01 minocycline 1% or 2% topical gel in the treatment of inflammatory non-nodular acne vulgaris
Secondary:
* To evaluate the plasma level of minocycline after once daily application of 1% or 2% BPX 01 topical gel
* To evaluate the safety of BPX-01 minocycline 1% or 2% topical gel
Endpoints:
Primary Efficacy Endpoint:
* Absolute mean change from baseline in inflammatory lesion counts at Week 12
Secondary Efficacy Endpoint:
* Proportion of subjects with at least a two-grade reduction in IGA at Week 12
Study Population: Approximately 225 male or female subjects aged between 9 and 40 years with moderate to severe inflammatory non-nodular acne vulgaris will be included in this study.
Number of Sites: Approximately 15 centers from the United States will participate in this study.
Study Duration: Overall study duration is expected to be approximately 24 weeks (6 months). The study duration for individual subjects is approximately 16 weeks (including the screening period).
Hypothesis: BPX-01 improves disease condition in subjects with moderate to severe inflammatory non-nodular acne vulgaris compared with vehicle.
Objectives:
Primary:
* To evaluate the efficacy of BPX-01 minocycline 1% or 2% topical gel in the treatment of inflammatory non-nodular acne vulgaris
Secondary:
* To evaluate the plasma level of minocycline after once daily application of 1% or 2% BPX 01 topical gel
* To evaluate the safety of BPX-01 minocycline 1% or 2% topical gel
Endpoints:
Primary Efficacy Endpoint:
* Absolute mean change from baseline in inflammatory lesion counts at Week 12
Secondary Efficacy Endpoint:
* Proportion of subjects with at least a two-grade reduction in IGA at Week 12
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: