PRISM: A Double Blind, Randomized, Vehicle Controlled Phase 2 Study to Assess the Safety and Efficacy of BPX-04 Minocycline Topical Gel in the Treatment of Inflammatory Lesions of Papulopustular Rosacea
试验速览
- 阶段
- 2 期
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Inflammatory lesion count
研究概览
简要总结
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.
详细描述
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.
Subjects will apply approximately 1 gram of topical gel once each day for a 12 week duration. They will come to the study site at Screening, Baseline, and Weeks 4, 8, and 12 or early termination (ET) for the protocol required efficacy and safety evaluations.
At each visit, efficacy will be assessed by rosacea lesion counts, IGA, PGI-S, PGI-I, CGI-S, CGI-I, RosaQoL, Erythema Assessment Scale, Telangiectasia Assessment Scale and subject satisfaction questionnaire.
Safety will be assessed with vital signs, physical examination, laboratory tests such as clinical hematology and chemistries, investigators' and subjects' assessments of cutaneous tolerability, incidence of minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri, and incidence of TEAEs. Blood samples will be collected to evaluate the level of minocycline in plasma at Baseline and Week 12/ET.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Vehicle control is identical to the active product in appearance
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Female subject who is breastfeeding, pregnant or who is planning a pregnancy during the study.
- •Participated in any clinical study with exposure to any investigational treatment or product within the previous 4 weeks to Baseline, or plan on concurrent participation in other studies.
研究组 & 干预措施
BPX-04 Active
BPX-04 1% minocycline topical gel
干预措施: minocycline topical gel (Drug)
BPX-04 Vehicle
BPX-04 topical gel vehicle
干预措施: topical gel vehicle (Drug)
结局指标
主要结局
Inflammatory lesion count
时间窗: Baseline to Week 12
Change in mean facial inflammatory lesion count
次要结局
- Change in IGA(Baseline to Week 12)