Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea

NCT03667222 | Unknown Phase 2 FDA Drug

• 1 other identifier: BPX-04-C07
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 12

Brief Summary

This is a 12-week, multicenter, double-blind, randomized, two-arm, vehicle controlled study. Subjects will be randomized 1:1 to BPX-04 minocycline topical gel 1% or vehicle. This study will include approximately 176 randomized subjects with inflammatory lesions of papulopustular rosacea on the face, defined by an IGA score of 3 (moderate) or 4 (severe) at Baseline. Subjects will be healthy male or female subjects aged 18 years or older. There will be up to 20 study sites in the USA.

Conditions

Papulopustular Rosacea

Outcome Measures

Primary Outcomes (1)

• Inflammatory lesion count

  Change in mean facial inflammatory lesion count

  Baseline to Week 12

Secondary Outcomes (1)

• Change in IGA

  Baseline to Week 12

Study Arms (2)

BPX-04 Active

EXPERIMENTAL

BPX-04 1% minocycline topical gel

Drug: minocycline topical gel

BPX-04 Vehicle

PLACEBO COMPARATOR

BPX-04 topical gel vehicle

Drug: topical gel vehicle

Interventions

minocycline topical gel DRUG

Once daily administration of BPX-04 minocycline gel for 12 weeks

BPX-04 Active

topical gel vehicle DRUG

Once daily administration of BPX-04 gel vehicle for 12 weeks

BPX-04 Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥18 years of age at the time of consent.
• Subjects do not have any medical conditions, other than rosacea, that in the opinion of the investigator, put the subject at unacceptable risk or could interfere with study assessments or integrity of the data.
• A clinical diagnosis of moderate to severe (Grade 3 or 4) facial rosacea (papulopustular (Subtype 2) or mixed erythematotelangiectatic (Subtype 1) and papulopustular (Subtype 2)) as determined by the Investigator's Global Assessment (IGA)
• Have 15-70 papulopustular lesions of rosacea on the face with no more than 2 nodules.
• Female subjects of childbearing potential are willing to use effective contraceptive method (s) for at least 4 weeks before Baseline and at least 4 weeks after the last study product administration or have a sterilized or same sex partner for the duration of the study. Effective contraceptive methods are: systemic hormonal contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicide or agree to sexual abstinence. Hormonal contraceptives must be on a stable dose for at least 12 weeks before Baseline. Subjects using low dose (≤35 ug ethinyl estradiol) oral contraceptives must use a second form of birth control (e.g., barrier method such as condoms with spermicide).
• Female subjects of childbearing potential must have a negative urine pregnancy test (dipstick).
• Subjects who use make-up, facial moisturizers, creams, lotions, cleansers and/or sunscreens must have used the same product brands/types for a minimum period of 2 weeks prior to Baseline, 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, lotions, cleansers and/or sunscreens on the scheduled clinic visit days before the visit.
• Be willing to limit or avoid known personal 'triggers' of rosacea such as spicy foods, consumption of alcoholic beverages, extended sun exposure, tanning beds, etc., for the duration of the study.
• Subjects must be capable of giving informed consent and the written informed consent must be obtained prior to any study-related procedures.

You may not qualify if:

• Have a history of skin disease, presence of skin condition, scarring or excessive facial hair the PI believes would interfere with the study.
• Have moderate or severe rhinophyma, severe telangiectasia or plaque-like facial edema.
• Have rosacea conglobata or fulminans, corticosteroid induced rosacea or facial erythrosis other than rosacea.
• Have ocular rosacea of a severity that requires systemic treatment.
• Have a history of any adverse reaction to minocycline or other tetracycline class antibiotic.
• Have a clinically significant chemistry or hematology value or have an ALT or AST that is greater than or equal to 2x normal.
• Have any conditions or factors that the PI believes may affect the response of the skin or the interpretation of the results.
• Have a history of symptoms that might be confused with a diagnosis of pseudotumor cerebri such as severe headaches or visual disturbances inconsistent with a diagnosis of migraine or have a history of traumatic brain injury with headache and/or visual disturbances.
• Have used on the face an over the counter (OTC) topical medication for the treatment of rosacea within 4 weeks prior to Baseline.
• Have used prescription topical (on the face) and/or oral antibiotics within 4 weeks prior to Baseline.
• Treatment with hormonal therapy or oral corticosteroids that is not on a stable dose and frequency for at least 12 weeks before Baseline and not stable throughout the study.
• Have had a facial procedure such as chemical peel, laser, microdermabrasion or injections with a dermal filler or neuromodulator within 8 weeks prior to Baseline.
• Have received photodynamic therapy or phototherapy to the face within 12 weeks prior to Baseline.
• Have used an oral retinoid within 6 months or a topical retinoid within 3 months prior to Baseline.
• Current drug or alcohol abuse.

Sponsors & Collaborators

• BioPharmX, Inc.: lead

Study Sites (12)

Study Center

Anaheim Hills, California, 92807, United States

Location

Study Center

Miami, Florida, 33175, United States

Location

Study Center

Miramar, Florida, 33027, United States

Location

Study Center

Baton Rouge, Louisiana, 70809, United States

Location

Study Center

New Orleans, Louisiana, 70115, United States

Location

Study Center

Needham, Massachusetts, 02135, United States

Location

Study Center

Saint Joseph, Missouri, 64506, United States

Location

Study Center

Morristown, New Jersey, 07960, United States

Location

Study Center

High Point, North Carolina, 27262, United States

Location

Study Center

Philadelphia, Pennsylvania, 19103, United States

Location

Study Center

Austin, Texas, 78759, United States

Location

Study Center

San Antonio, Texas, 78213, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

Gels

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• AnnaMarie Daniels

  BioPharmX, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Vehicle control is identical to the active product in appearance
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: September 18, 2018
• Primary Completion: May 17, 2019
• Study Completion: August 17, 2019
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)