Open Label Photo-Documentation Study Of BPX-01 Minocycline Gel

Acne Vulgaris Clinical Trial

Official title:

An Open Label Study to Document the Treatment Effect of 1 and 2% BPX-01 Minocycline Topical Gel in Moderate to Severe Inflammatory Non-nodular Acne Vulgaris (Protocol Number BPX-01-C04)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946788
• Other study ID #: BPX-01-C04
• Status: Completed
• Phase: Phase 2
• Start date: March 13, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: July 2022
• Source: BioPharmX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi center open label study intended to provide photo documentation and time to response data for BPX-01 1 and 2% minocycline topical gel for the treatment of moderate to severe non-nodular inflammatory acne vulgarism.

Description:

This was a 12-week, multi-center, open label, two-arm study. Subjects will be assigned to treatment with 1% or 2% BPX-01 gel. Subjects will apply 1g of the gel as a thin film to the entire face at least 30 minutes before bedtime each night for 12 weeks. Lesion counts, IGA, and Patient-Reported Outcomes (PGI-S and PGI-I) will be performed to assess efficacy. Photographs will be taken to document treatment effect.

Safety will be assessed with the vital signs, brief physical examination, clinical laboratory tests, cutaneous tolerance score, incidence of minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri, incidence of product related facial staining and collection of adverse events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• moderate to severe inflammatory non-nodular acne vulgaris

Exclusion Criteria:

• female subject who is breastfeeding, pregnant or planning a pregnancy during the study

• have other skin condition or disease that would interfere with the study

• have had any prior treatment with minocycline

• have a known or suspected allergy to tetracycline class products

• have used OTC medications for the treatment of facial acne within the last 14 days

• have used any prescription topical or oral medications for the treatment of facial acne in the last 28 days

• have had a facial procedure (chemical peel, dermabrasion, laser, etc) within the last 8 weeks

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Minocycline
BPX-01 1 or 2% topical gel will be applied to face once daily

Locations

Country	Name	City	State
United States	Study Center	Coral Gables	Florida
United States	Study Center	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
BioPharmX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Inflammatory Lesion Counts at Week 12	difference in number of inflammatory lesions at week 12 as compared to baseline	12 weeks