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Trial record 92 of 339 for:    acne AND facial

BPX-01 Minocycline 1% Topical Gel for Reduction of Propionibacterium Acnes

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: NCT02709096
Recruitment Status : Completed
First Posted : March 15, 2016
Results First Posted : September 14, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
BioPharmX, Inc.

Tracking Information
First Submitted Date  ICMJE March 10, 2016
First Posted Date  ICMJE March 15, 2016
Results First Submitted Date  ICMJE July 18, 2017
Results First Posted Date  ICMJE September 14, 2017
Last Update Posted Date September 14, 2017
Study Start Date  ICMJE April 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2017)
Logarithmic Change in Colony Counts of Facial Propionibacterium Acnes [ Time Frame: Cultures will be evaluated at Baseline, Week 1, Week 2, Week 4 and Week 6. Values reported at week 4 compared to baseline. ]
P. Acnes cultures will be collected using the modified Kligman Method at each study visit. After plating, the samples will be cultured for 7 days and then evaluated.
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
Logarithmic Change in Colony Counts of Facial Propionibacterium Acnes [ Time Frame: Cultures will be evaluated at Baseline, Week 1, Week 2, Week 4 and Week 6 ]
P. Acnes cultures will be collected using the modified Kligman Method at each study visit. After plating, the samples will be cultured for 7 days and then evaluated.
Change History Complete list of historical versions of study NCT02709096 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 BPX-01 Minocycline 1% Topical Gel for Reduction of Propionibacterium Acnes
Official Title  ICMJE BPX-01 Minocycline 1% Topical Gel for Reduction of Propionibacterium Acnes
Brief Summary This is a Phase 2a study which is being conducted in healthy volunteers in order to evaluate the comparative reduction of Propionibacterium acnes in-vivo following once daily topical administration of BPX-01 Minocycline 1% Topical Gel (BPX-01) or BPX-01 Vehicle control.
Detailed Description

The objective of this study is to evaluate the comparative reduction of Propionibacterium acnes (P. acnes) in-vivo following once daily topical administration of BPX-01 Minocycline 1% Topical Gel or BPX-01 Vehicle control Gel.

A secondary objective is to assess the tolerance of the treatment regimen versus a vehicle control. Safety laboratory data (chemistry and hematology) and plasma levels of minocycline are also of significant interest to the sponsor.

This is a single center, randomized, double blind, two-cell, vehicle controlled P. acnes study. All subjects will be randomized 2:1 to 1% BPX-01 or vehicle control to be applied as a topical gel once daily for four (4) weeks.

This is a six (6) week study with a four (4) week treatment period and a two (2) week post treatment follow up visit. The clinical endpoint is in-vivo quantification of P.acnes. The safety/tolerance endpoints are; observer reported: erythema, scaling-peeling, edema, and subject reported: tightness, burning-stinging, and itching. Plasma levels of minocycline and basic hematology and chemistry laboratory values will be collected.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: BPX-01, 1% Topical Gel
    topical gel, applied to the forehead, cheeks, nose and chin
    Other Name: BPX-01 Topical Gel
  • Drug: BPX-01 Vehicle Gel
    topical gel, applied to the forehead, cheeks, nose and chin
    Other Name: BPX-01 Vehicle
Study Arms  ICMJE
  • Experimental: BPX-01, 1% Topical Gel
    BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.
    Intervention: Drug: BPX-01, 1% Topical Gel
  • Placebo Comparator: BPX-01, Vehicle Gel
    BPX-01, Vehicle Gel; applied once daily to the face for four weeks.
    Intervention: Drug: BPX-01 Vehicle Gel
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: August 16, 2017)
33
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2016)
30
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Be a healthy, adult male and/or female volunteer 18 to 40 years of age with no past or present history of any significant disease based on PI discretion;
  2. If female, must be post-menopausal, surgically sterile, or using effective birth control methods with a negative urine pregnancy test at the Screening and Baseline visits (female subjects of childbearing potential only);
  3. Show a high degree of fluorescence of the face under a Wood's lamp at the screening visit.
  4. Be willing to refrain from using antimicrobial topical products for the duration of study participation;
  5. Be willing to return to the study center for all study visits;
  6. Be willing to follow all study instructions and adhere to study restrictions;
  7. Provide informed consent to the study procedures and restrictions

Exclusion Criteria:

  1. Have a history of skin disease or presence of skin condition the PI believes would interfere with the study;
  2. Females who report that they are pregnant, planning a pregnancy or breastfeeding or those females who are of child bearing potential, that test positive with a urine pregnancy test;
  3. Have conditions or factors that the PI believes may affect the response of the skin or the interpretation of the results;
  4. Participated in any clinical study within the previous 30 days, be concurrently participating in other studies, or be involved in any aspect of test administration;
  5. Use of topical or systemic antibiotics or other products within the previous 4 weeks prior to baseline, that influence P. acnes counts;
  6. Are known to be allergic to any of the test product(s) or any components in the test product(s);
  7. Have a history of significant medical condition/disease that the PI believes may affect the response of the skin or the interpretation of the results;
  8. Has any other condition that, in the opinion of the Investigator or his designee, could interfere with the subject's ability to use the treatment as instructed, alter their treatment response, or affect their ability to complete the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT02709096
Other Study ID Numbers  ICMJE BPX-01-C02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party BioPharmX, Inc.
Study Sponsor  ICMJE BioPharmX, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stuart Lessin, MD KGL, Inc.
PRS Account BioPharmX, Inc.
Verification Date August 2017

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