BPX-01 Minocycline Topical Gel in the Treatment of Acne Vulgaris

NCT02815332 | Completed Phase 2

• 1 other identifier: BPX-01-C03
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 15

Brief Summary

This is a 12-week, multi-center, double-blind, randomized, three-arm, vehicle-controlled study. Subjects will be randomized (1:1:1) to 1% or 2 % BPX-01 gel, or vehicle. 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. Blood draws will be collected at baseline (Day 0), and at Weeks 4 and 12 to evaluate the level of minocycline in plasma. 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, and collection of adverse events.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Change in inflammatory lesion counts

  Absolute mean change from baseline in inflammatory lesion counts

  12 weeks

Secondary Outcomes (1)

• Reduction in IGA

  12 weeks

Study Arms (3)

BPX-01 Vehicle Topical Gel

PLACEBO COMPARATOR

Approximately 1 gram applied once daily for 12 weeks

Drug: BPX-01 Vehicle Topical Gel

BPX-01 1% Minocycline Topical Gel

EXPERIMENTAL

Approximately 1 gram applied once daily for 12 weeks

Drug: BPX-01 1% Minocycline Topical Gel

BPX-01 2% Minocycline Topical Gel

EXPERIMENTAL

Approximately 1 gram applied once daily for 12 weeks

Drug: BPX-01 2% Minocycline Topical Gel

Interventions

BPX-01 1% Minocycline Topical Gel DRUG

Approximately 1 gram applied once daily for 12 weeks

Also known as: BPX-01 Topical Gel

BPX-01 1% Minocycline Topical Gel

BPX-01 2% Minocycline Topical Gel DRUG

Approximately 1 gram applied once daily for 12 weeks

Also known as: BPX-01 Topical Gel

BPX-01 2% Minocycline Topical Gel

BPX-01 Vehicle Topical Gel DRUG

Approximately 1 gram applied once daily for 12 weeks

Also known as: BPX-01 Vehicle Gel

BPX-01 Vehicle Topical Gel

Eligibility Criteria

• Age: 9 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female subjects aged between 9 and 40 years of age.
• Subjects do not have any medical conditions, other than acne vulgaris, that in the opinion of the investigator, put the subject at unacceptable risk or could interfere with study assessments or integrity of the data.
• Moderate to severe inflammatory non-nodular acne vulgaris.
• Female subjects of childbearing potential (including pre-puberty) are willing to use effective contraceptive method for at least 28 days before baseline (Day 0) and at least 28 days after the last study product administration or have a sterilized or same-sex partner for the duration of the study.
• Treatment with hormonal therapy must be on a stable dose and frequency for at least 12 weeks before baseline (Day 0) and must remain stable throughout the study.
• Subjects who use make-up, facial moisturizers, creams, or lotions, cleansers and/or sunscreens must have used the same product brands/types for a minimum period of 14 days prior to baseline (Day 0), must agree not to change brand/type or frequency of use throughout the study and must agree not to use make-up, facial moisturizers, creams, or lotions, cleansers and/or sunscreens on the clinic visit days before the visit.
• Subjects must be capable of giving informed consent and the written informed consent must be obtained prior to any study-related procedures. Subject under 18 years of age must sign an assent form, and their parent(s) or legal representative must have read and signed the informed consent form prior to any study-related procedures.

You may not qualify if:

• Female subject who is breastfeeding, pregnant or who is planning a pregnancy during the study.
• Have acne fulminans or conglobata, or nodulocystic acne.
• Have a history of skin disease, presence of skin condition, or excessive facial hair that, in the opinion of the investigator, would interfere with the study.
• Have a history of cancer or lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
• Have a history of minocycline-induced hepatitis, minocycline-induced arthritis, minocycline-induced lupus or minocycline/tetracycline-induced pseudotumor cerebri.
• Presence of minocycline-induced hyperpigmentation at screening or baseline (Day 0).
• Presence of visual disturbances and/or headaches suggestive of pseudotumor cerebri at screening or baseline (Day 0).
• Have a clinical chemistry or hematology laboratory value that is abnormal at the screening visit and that is considered clinically significant by the investigator.
• Has an ALT or AST at screening greater than or equal to 2 times the upper limit of normal.
• Have used on the face an over-the-counter (OTC) topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, salicylic acid, α-hydroxy/glycolic, antibacterial/antiseptic soap or wash within 14 days prior to baseline (Day 0).
• Have used prescription topical retinoid (e.g. tretinoin, tazarotene, adapalene) or antimicrobials (e.g. clindamycin, erythromycin) or other prescription topical medications for the treatment of acne vulgaris within 28 days of baseline (Day 0).
• Have used oral, intranasal, or injectable corticosteroids within 28 days of baseline (Day 0) or require them during the study. Inhaled corticosteroids for stable medical conditions are allowed.
• Have received an investigational therapy (including investigational drug or procedure) within 28 days of baseline (Day 0) or plan to use one during the study.
• Have had a facial procedure (e.g. chemical peel, laser, microdermabrasion) within 8 weeks of baseline (Day 0).
• Have excessive sun exposure, is planning a trip to a sunny climate or used tanning booths within 28 days prior to baseline (Day 0) or is not willing to minimize natural and artificial sunlight exposure during the study.

Sponsors & Collaborators

• BioPharmX, Inc.: lead

Study Sites (15)

Unknown Facility

Santa Monica, California, United States

Location

Unknown Facility

Coral Gables, Florida, United States

Location

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Lake Mary, Florida, United States

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Newnan, Georgia, United States

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Louisville, Kentucky, United States

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Las Vegas, Nevada, United States

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Montclair, New Jersey, United States

Location

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New York, New York, United States

Location

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Highpoint, North Carolina, United States

Location

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Murfreesboro, Tennessee, United States

Location

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Nashville, Tennessee, United States

Location

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Pflugerville, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Spokane, Washington, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Study Officials

• AnnaMarie Daniels

  Sponsor (BioPharmX)

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: June 28, 2016
• Study Start: August 1, 2016
• Primary Completion: March 24, 2017
• Study Completion: March 24, 2017
• Last Updated: April 14, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

US (15)