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Trial record 34 of 164 for:    acne AND Vehicle

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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: BPX-01, 1% Topical Gel
Drug: BPX-01 Vehicle Gel
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BPX-01, 1% Topical Gel BPX-01, Vehicle Gel
Hide Arm/Group Description

BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.

BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin

BPX-01, Vehicle Gel; applied once daily to the face for four weeks.

BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin

Period Title: Overall Study
Started 22 11
Completed 21 10
Not Completed 1 1
Reason Not Completed
non-compliance             1             1
Arm/Group Title BPX-01, 1% Topical Gel BPX-01, Vehicle Gel Total
Hide Arm/Group Description

BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.

BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin

BPX-01, Vehicle Gel; applied once daily to the face for four weeks.

BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin

Total of all reporting groups
Overall Number of Baseline Participants 22 11 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants 11 participants 33 participants
32
(19 to 41)
34
(24 to 40)
32
(19 to 41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 11 participants 33 participants
Female
16
  72.7%
8
  72.7%
24
  72.7%
Male
6
  27.3%
3
  27.3%
9
  27.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 11 participants 33 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   9.1%
2
  18.2%
4
  12.1%
White
20
  90.9%
9
  81.8%
29
  87.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 11 participants 33 participants
22 11 33
1.Primary Outcome
Title Logarithmic Change in Colony Counts of Facial Propionibacterium Acnes
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population included all subjects with evaluable data and no major protocol violations.
Arm/Group Title BPX-01, 1% Topical Gel BPX-01, Vehicle Gel
Hide Arm/Group Description:

BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.

BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin

BPX-01, Vehicle Gel; applied once daily to the face for four weeks.

BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin

Overall Number of Participants Analyzed 17 7
Mean (Standard Deviation)
Unit of Measure: log change in colony forming units
-1.0376  (0.5479) -0.4614  (0.4042)
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BPX-01, 1% Topical Gel BPX-01, Vehicle Gel
Hide Arm/Group Description

BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.

BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin

BPX-01, Vehicle Gel; applied once daily to the face for four weeks.

BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin

All-Cause Mortality
BPX-01, 1% Topical Gel BPX-01, Vehicle Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)      0/11 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
BPX-01, 1% Topical Gel BPX-01, Vehicle Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      1/11 (9.09%)    
Renal and urinary disorders     
Kidney stone   0/22 (0.00%)  0 1/11 (9.09%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BPX-01, 1% Topical Gel BPX-01, Vehicle Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/22 (18.18%)      1/11 (9.09%)    
Ear and labyrinth disorders     
Ear pain   1/22 (4.55%)  1 0/11 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Upper respiratory infection   2/22 (9.09%)  2 0/11 (0.00%)  0
Pharyngitis   0/22 (0.00%)  0 1/11 (9.09%)  1
Sinus infection   1/22 (4.55%)  1 0/11 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: AnnaMarie Daniels
Organization: BioPharmX, Inc.
Phone: 310-701-2080
EMail: amdaniels@biopharmx.com
Layout table for additonal information
Responsible Party: BioPharmX, Inc.
ClinicalTrials.gov Identifier: NCT02709096     History of Changes
Other Study ID Numbers: BPX-01-C02
First Submitted: March 10, 2016
First Posted: March 15, 2016
Results First Submitted: July 18, 2017
Results First Posted: September 14, 2017
Last Update Posted: September 14, 2017