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

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ClinicalTrials.gov Identifier: NCT02946788
Recruitment Status : Completed
First Posted : October 27, 2016
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
BioPharmX, Inc.

Tracking Information
First Submitted Date  ICMJE October 25, 2016
First Posted Date  ICMJE October 27, 2016
Last Update Posted Date June 6, 2018
Actual Study Start Date  ICMJE March 13, 2017
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2017)
Photo-documentation of response [ Time Frame: 12 weeks ]
photographic documentation of lesion response
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2016)
Photo-documentation of response [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT02946788 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Photo-Documentation Study Of BPX-01 Minocycline Gel
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE Drug: Minocycline
BPX-01 1 or 2% topical gel will be applied to face once daily
Study Arms  ICMJE
  • Experimental: BPX-01 1%
    BPX-01 1% minocycline topical gel
    Intervention: Drug: Minocycline
  • Experimental: BPX-01 2%
    BPX-01 2% minocycline topical gel
    Intervention: Drug: Minocycline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1, 2018
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02946788
Other Study ID Numbers  ICMJE BPX-01-C04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party BioPharmX, Inc.
Study Sponsor  ICMJE BioPharmX, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AnnaMarie Daniels BioPharmX, Inc.
PRS Account BioPharmX, Inc.
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP