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

• 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: BioPharmX, Inc.
• Information provided by (Responsible Party): BioPharmX, Inc.

Tracking Information

• First Submitted Date: March 10, 2016
• First Posted Date: March 15, 2016
• Results First Submitted Date: July 18, 2017
• Results First Posted Date: September 14, 2017
• Last Update Posted Date: September 14, 2017
• Study Start Date: April 2016
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: BPX-01 Minocycline 1% Topical Gel for Reduction of Propionibacterium Acnes
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Acne Vulgaris

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 16, 2017): 33
• Original Estimated Enrollment (submitted: March 14, 2016): 30
• Actual Study Completion Date: June 2016
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02709096
• Other Study ID Numbers: BPX-01-C02
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: BioPharmX, Inc.
• Study Sponsor: BioPharmX, Inc.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Stuart Lessin, MD; KGL, Inc.

• PRS Account: BioPharmX, Inc.
• Verification Date: August 2017