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

NCT02709096 | Completed Phase 2 Results

• 1 other identifier: BPX-01-C02
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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.

  Cultures will be evaluated at Baseline, Week 1, Week 2, Week 4 and Week 6. Values reported at week 4 compared to baseline.

Study Arms (2)

BPX-01, 1% Topical Gel

EXPERIMENTAL

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

Drug: BPX-01, 1% Topical Gel

BPX-01, Vehicle Gel

PLACEBO COMPARATOR

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

Drug: BPX-01 Vehicle Gel

Interventions

BPX-01, 1% Topical Gel DRUG

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

Also known as: BPX-01 Topical Gel

BPX-01, 1% Topical Gel

BPX-01 Vehicle Gel DRUG

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

Also known as: BPX-01 Vehicle

BPX-01, Vehicle Gel

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioPharmX, Inc.: lead

Study Sites (1)

KGL Skin Study Center

Broomall, Pennsylvania, 19008, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Gels

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: AnnaMarie Daniels
• Organization: BioPharmX, Inc.

amdaniels@biopharmx.com

310-701-2080

Study Officials

• Stuart Lessin, MD

  KGL, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 15, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 14, 2017
• Results First Posted: September 14, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)