NCT05231044已完成3 期
A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy, Safety and PK Study of KX01 Ointment 1% in Japanese Adult Subjects With Actinic Keratosis on the Face or Scalp
PharmaEssentia20 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2021年12月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 20
- 主要终点
- Percentage of participants with complete (100%) clearance of Actinic Keratosis (AK) lesions
研究概览
简要总结
This Phase III study is designed to evaluate the efficacy and safety of KX01 Ointment in adult participants when applied to an area of skin containing more than 1, clinically typical Actinic Keratosis (AK) lesions on the face or scalp.
详细描述
This study is a double-blinded, multicenter, activity, and safety study of KX01 Ointment administered topically to the face or scalp of participants with actinic keratosis. The study consists of Screening, Treatment, Follow-up, and Recurrence Follow-up Periods. Eligible participants received 5 consecutive days of topical treatment, to be applied at the study site. Activity (lesion counts) and safety evaluations is performed.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese Males and females ≥20 years old
- •A treatment area on the face or scalp that:
- •is a contiguous area measured 25 cm2
- •contains more than 1 clinically typical, visible, and discrete AK lesions
- •Subjects who, in the judgment of the Investigator or Sub-investigator, are in good general health based on:
- •medical history
- •physical examination (PE) findings
- •vital signs
- •clinical chemistry, hematology, and urinalysis results
- •Females must be postmenopausal (>45 years of age with at least 12 months of amenorrhea), surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal ligation); or, women with childbearing potential must use highly effective contraception for at least 30 days or 1 menstrual cycle, whichever is longer, prior to study treatment and must agree to continue to use highly effective contraception for at least 30 days following their last dose of study treatment. Highly effective contraception includes oral hormonal contraceptives, hormonal contraceptive implant, injection or patch, intrauterine device, or complete abstinence from sexual intercourse.
- •Sexually active males who have not had a vasectomy and whose partner is reproductively capable must agree to use barrier contraception from Screening until 90 days after their last dose of study treatment.
- •All subjects must agree not to donate sperm or eggs or attempt conception from Screening until 90 days following their last dose of study treatment.
- •Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 prior to randomization.
- •Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp
排除标准
- •Clinically atypical and / or rapidly changing AK lesions on the treatment area, e.g., hypertrophic, hyperkeratotic, recalcitrant disease (had cryosurgery on two previous occasions) and / or cutaneous horn
- •Location of the treatment area is:
- •On any location other than the face or scalp
- •Within 5 cm of an incompletely healed wound
- •Within 5 cm of a suspected basal cell carcinoma (BCC) or SCC
- •Been previously treated with KX01 Ointment
- •Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day 57
- •Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within the treatment area or within 2 cm of the treatment area, within 8 weeks prior to the Screening visit
- •Use of the following therapies and / or medications within 2 weeks prior to the Screening visit:
- •Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the treatment area or within 2 cm of the selected treatment area
- •Acid-containing therapeutic products (e.g., salicylic acid or fruit acids, such as alpha- and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within the treatment area or within 2 cm of the selected treatment area
- •Topical salves (non-medicated / non-irritant lotion and cream are acceptable) or topical steroids within the treatment area or within 2 cm of the selected treatment area; artificial tanners within the treatment area or within 5 cm of the selected treatment area
- •Use of the following therapies and / or medications within 4 weeks prior to the Screening visit:
- •Treatment with immunomodulators (e.g., azathioprine), cytotoxic drugs (e.g., cyclophosphamide, vinblastine, chlorambucil, methotrexate), or interferons / interferon inducers
研究组 & 干预措施
KX01 Ointment 1%
Experimental
KX01 Ointment 1% is applied topically once daily for 5 consecutive days on face or scalp
干预措施: KX01 ointment 1% (Drug)
Placebo
Placebo Comparator
Vehicle Ointment is applied topically once daily for 5 consecutive days on face or scalp
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of participants with complete (100%) clearance of Actinic Keratosis (AK) lesions
时间窗: Day 57
Complete clearance rate is defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area.
次要结局
- Number of participants with local skin reactions (LSR) in the treatment area(Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57)
- Number of participants with AEs within the treatment area after Day 57 up to 12 months post-Day 57(After Day 57 up to 12 months post-Day 57)
- Partial Clearance Rate of AK Lesions at Day 57(Day 57)
- Recurrence rate of AK lesions in subjects who achieved complete clearance at Day 57(3, 6, 9 and 12 months post-Day 57)
- Number of participants with pigmentation and scarring in the treatment area(Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57)
- Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs), events of special interest(From Baseline (Day 1 predose) up to Day 57)
研究者
研究点 (20)
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