A Phase 1 and 2 Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, Efficacy, and Exposure of up to 12 Weeks of XPF-005 Treatment in Healthy Volunteers and Subjects With Acne Vulgaris
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 20
- 主要终点
- Change from Baseline in acne lesion count
研究概览
简要总结
Phase 1/2 study enrolling up to 60 healthy volunteers in Phase 1 followed by approximately 150 subjects with acne vulgaris in Phase 2.
详细描述
Phase 1/2 study enrolling up to 60 healthy volunteers followed by approximately 150 subjects with acne vulgaris. Data from Phase 1 stage will be reviewed before progressing to Phase 2.
Phase 1 is an open label study to determine safety, tolerability of XPF-005 topical gel and exposure of XEN801 (active ingredient). Up to 5 cohorts of 12 healthy volunteers will each receive different dose volumes of XPF-005 gel or Placebo gel on their face and back for 14 or 21 days. Safety assessments are completed and PK samples are collected at study visits.
Phase 2 is a randomized, double-blind, vehicle-controlled, parallel-group study to determine safety, tolerability, efficacy of XPF-005 topical gel and exposure of XEN801 (active ingredient). Approximately 150 subjects with acne vulgaris will apply XPF-005 or matching placebo gel on their face for 12 weeks. Safety and efficacy assessments are completed and PK samples are collected at study visits.
Safety assessments include local skin tolerability assessments, vital signs, physical examination, 12-lead ECG, safety laboratory blood and urine and adverse event reporting.
Efficacy assessments include acne lesion counts and Investigator's Global Assessment (IGA).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 50, inclusive
- •Male or female, agree to comply with contraceptive requirements
- •Signed Informed Consent Form
- •Clinical diagnosis of facial acne vulgaris defined as:
- •25 to 75 inflammatory lesions,
- •20 to 120 non-inflammatory lesions, and
- •an IGA score of ≥3
- •Agree to refrain from using any topical acne treatments on the face or any oral acne treatments. Topical acne treatment that do not have significant or measurable systemic absorption are permitted for treatment of the back, shoulders, and chest only
排除标准
- •Known sensitivity to any topical or dermal product, including alcohol
- •Female who is breast feeding, pregnant, or planning to become pregnant
- •Any skin condition of the face other than acne vulgaris
- •Two or more active nodular lesions
- •Excessive facial hair that would interfere with the evaluation of safety or with the diagnosis or assessment of acne vulgaris
- •Use of tanning beds/booths, or excessive sun exposure
- •Use of over-the-counter topical medications for treatment of acne vulgaris on the face within 14 days of baseline
- •Use of systemic corticosteroids, antibiotics, anti-acne drugs, anti-inflammatory drugs (NSAIDs are permitted) or prescription topical retinoid use on the face within 28 days prior the baseline
- •Initiation of hormonal therapy or dose change to hormonal therapy within 12 weeks prior to baseline.
- •Use of androgen receptor blockers (eg, spironolactone, flutamide) within 12 weeks prior to baseline
- •Use of oral retinoid (eg, isotretinoin, alitretinoin) within 12 months prior to baseline and vitamin A supplements >10,000 units/day within 6 months prior to baseline
- •Facial procedures (eg, microdermabrasion, chemical or laser peel) within 8 weeks prior to baseline
- •Photodynamic therapy within 12 weeks prior to baseline
- •Any other reason that would make the subject, in the opinion of the Investigator or Sponsor, unsuitable for the study
研究组 & 干预措施
XPF-005
Active treatment: XPF-005 Gel
干预措施: XPF-005 (Drug)
Vehicle gel
Placebo: XPF-005 Vehicle Gel
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in acne lesion count
时间窗: Week 12
次要结局
- Change from Baseline in Investigator Global Assessment (IGA)(Week 4, 8 and 12)
- Change from Baseline in acne lesion count(Week 4 and 8)