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Open Label Photo-Documentation Study Of BPX-01 Minocycline Gel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02946788
Recruitment Status : Completed
First Posted : October 27, 2016
Results First Posted : July 26, 2022
Last Update Posted : July 26, 2022
Sponsor:
Information provided by (Responsible Party):
BioPharmX, Inc.

Brief Summary:
This is a multi center open label study intended to provide photo documentation and time to response data for BPX-01 1 and 2% minocycline topical gel for the treatment of moderate to severe non-nodular inflammatory acne vulgarism.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Minocycline Phase 2

Detailed Description:

This was a 12-week, multi-center, open label, two-arm study. Subjects will be assigned to treatment with 1% or 2% BPX-01 gel. 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. Photographs will be taken to document treatment effect.

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, incidence of product related facial staining and collection of adverse events.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study to Document the Treatment Effect of 1 and 2% BPX-01 Minocycline Topical Gel in Moderate to Severe Inflammatory Non-nodular Acne Vulgaris (Protocol Number BPX-01-C04)
Actual Study Start Date : March 13, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: BPX-01 1%
BPX-01 1% minocycline topical gel
Drug: Minocycline
BPX-01 1 or 2% topical gel will be applied to face once daily
Other Name: BPX-01

Experimental: BPX-01 2%
BPX-01 2% minocycline topical gel
Drug: Minocycline
BPX-01 1 or 2% topical gel will be applied to face once daily
Other Name: BPX-01




Primary Outcome Measures :
  1. Change From Baseline in Inflammatory Lesion Counts at Week 12 [ Time Frame: 12 weeks ]
    difference in number of inflammatory lesions at week 12 as compared to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- moderate to severe inflammatory non-nodular acne vulgaris

Exclusion Criteria:

  • female subject who is breastfeeding, pregnant or planning a pregnancy during the study
  • have other skin condition or disease that would interfere with the study
  • have had any prior treatment with minocycline
  • have a known or suspected allergy to tetracycline class products
  • have used OTC medications for the treatment of facial acne within the last 14 days
  • have used any prescription topical or oral medications for the treatment of facial acne in the last 28 days
  • have had a facial procedure (chemical peel, dermabrasion, laser, etc) within the last 8 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946788


Locations
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United States, Florida
Study Center
Coral Gables, Florida, United States, 33146
United States, Nevada
Study Center
Las Vegas, Nevada, United States, 89128
Sponsors and Collaborators
BioPharmX, Inc.
Investigators
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Study Director: AnnaMarie Daniels BioPharmX, Inc.
  Study Documents (Full-Text)

Documents provided by BioPharmX, Inc.:
Study Protocol  [PDF] July 6, 2017
No Statistical Analysis Plan (SAP) exists for this study.

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Responsible Party: BioPharmX, Inc.
ClinicalTrials.gov Identifier: NCT02946788    
Other Study ID Numbers: BPX-01-C04
First Posted: October 27, 2016    Key Record Dates
Results First Posted: July 26, 2022
Last Update Posted: July 26, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents