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

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

BPX-01, 1% Topical Gel

BPX-01 Vehicle Gel

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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;
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);
Show a high degree of fluorescence of the face under a Wood's lamp at the screening visit.
Be willing to refrain from using antimicrobial topical products for the duration of study participation;
Be willing to return to the study center for all study visits;
Be willing to follow all study instructions and adhere to study restrictions;
Provide informed consent to the study procedures and restrictions

Exclusion Criteria:

Have a history of skin disease or presence of skin condition the PI believes would interfere with the study;
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;
Have conditions or factors that the PI believes may affect the response of the skin or the interpretation of the results;
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;
Use of topical or systemic antibiotics or other products within the previous 4 weeks prior to baseline, that influence P. acnes counts;
Are known to be allergic to any of the test product(s) or any components in the test product(s);
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;
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

Sites / Locations

KGL Skin Study Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BPX-01, 1% Topical Gel

BPX-01, Vehicle Gel

Arm Description

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

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

Outcomes

Primary Outcome Measures

Logarithmic Change in Colony Counts of Facial Propionibacterium Acnes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02709096

First Posted

March 10, 2016

Last Updated

August 16, 2017

Sponsor

BioPharmX, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02709096

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BioPharmX, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BPX-01, 1% Topical Gel

Arm Type

Experimental

Arm Description

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

Arm Title

BPX-01, Vehicle Gel

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

BPX-01, 1% Topical Gel

Other Intervention Name(s)

BPX-01 Topical Gel

Intervention Description

topical gel, applied to the forehead, cheeks, nose and chin

Intervention Type

Drug

Intervention Name(s)

BPX-01 Vehicle Gel

Other Intervention Name(s)

BPX-01 Vehicle

Intervention Description

topical gel, applied to the forehead, cheeks, nose and chin

Primary Outcome Measure Information:

Title

Logarithmic Change in Colony Counts of Facial Propionibacterium Acnes

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; 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); Show a high degree of fluorescence of the face under a Wood's lamp at the screening visit. Be willing to refrain from using antimicrobial topical products for the duration of study participation; Be willing to return to the study center for all study visits; Be willing to follow all study instructions and adhere to study restrictions; Provide informed consent to the study procedures and restrictions Exclusion Criteria: Have a history of skin disease or presence of skin condition the PI believes would interfere with the study; 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; Have conditions or factors that the PI believes may affect the response of the skin or the interpretation of the results; 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; Use of topical or systemic antibiotics or other products within the previous 4 weeks prior to baseline, that influence P. acnes counts; Are known to be allergic to any of the test product(s) or any components in the test product(s); 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; 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stuart Lessin, MD

Organizational Affiliation

KGL, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

KGL Skin Study Center

City

Broomall

State/Province

Pennsylvania

ZIP/Postal Code

19008

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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