CTRI/2021/11/038001已完成3 期
A randomized phase III, three-parallel arm, assessor blind, multi-centre study to evaluate the efficacy, safety and tolerability of AKP02 cutaneous spray (calcipotriol (plus) betamethasone dipropionate) versus Enstilar cutaneous foam (calcipotriol (plus) betamethasone dipropionate) in subjects with mild to moderate psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Lipidor AB
- 入组人数
- 294
- 试验地点
- 16
- 主要终点
- Comparison of change in PASI score between AKP02 cutaneous spray and Enstilar cutaneous foam
研究概览
简要总结
This is a Phase-III, randomized, assessor blind, parallel group, three arms, active and placebo controlled study to study efficacy and safety for topical cutaneous spray containing calcipotriol and betamethasone dipropionate 0.005%/0.064% in subjects with mild to moderate plaque psoriasis (psoriasis vulgaris)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or non-pregnant female subjects aged >18 years with general good health and having either Fitzpatrick skin type I–III or IV–VI
- •A clinical diagnosis of stable (at least 6 months) psoriasis vulgaris on body, or body and scalp, involving 5 to 10% of BSA and PASI ≤10., that does not include the face, axilla and groin areas.
- •Mild or moderate Psoriasis on (PGA) score (2 or 3).
- •A plaque elevation of at least moderate severity (grade ≥ 3) at the target lesion site.
- •Subjects must be willing to provide written informed consent and able to understand and can comply with study requirements.
排除标准
- •Subject with history of hypersensitivity to betamethasone or calcipotriol or any component of the study medication.
- •Current diagnosis of unstable forms of psoriasis in the treatment area
- •Subjects with diagnosis of mild to moderate psoriasis only in the scalp area.
- •Other inflammatory skin disease in the treatment area
- •Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas, which could interfere with the rating of efficacy parameters.
- •Subject with history of psoriasis unresponsive to topical treatments and in need of systemic treatment
- •Subject with psoriasis lesions predominantly on palms and soles or palmo-plantar psoriasis.
- •Ongoing use of other psoriasis treatment including but not limited to topical or systemic corticosteroids, other topical medications (i.e. coal tar), oral or biologic medications for the treatment of psoriasis, and UV therapy.
- •Use of oral estrogen therapy, excluding oral contraceptive pills
- •Females of childbearing potential not agree to utilize contraception and who are pregnant, nursing, or planning a pregnancy
- •Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamics half-lives, if known (whichever is longer)
- •Current or past history of hypercalcemia, calcium metabolism disorder, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders.
- •Current immunosuppression and positive for serology tests like HIV, HCV & HBsAg.
- •Use of biologic treatment for psoriasis (e.g., infliximab, adalimumab, alefacept) within six months prior to Baseline.
- •Use of: 1) chemotherapy, or 2) radiation therapy, within three months prior to Baseline.
- •Use of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) oral retinoids, within two months prior to Baseline.
- •Use of: 1) systemic steroids, 2) systemic antibiotics, 3) other systemic antipsoriatic treatment, 4) PUVA therapy, 5) UVB therapy, or 6) systemic anti-inflammatory agents, within one month prior to Baseline.
- •Use of: 1) topical anti-psoriatic drugs, 2) topical corticosteroids, or 3) topical retinoids, within 2 weeks prior to Baseline.
- •Use of medicated shampoos with possible effect on psoriasis.
结局指标
主要结局
Comparison of change in PASI score between AKP02 cutaneous spray and Enstilar cutaneous foam
时间窗: From baseline/randomization to Week 4
次要结局
- To evaluate the difference of change in psoriasis severity between AKP02 cutaneous spray and Enstilar cutaneous foam based on PSSI, PGA and ScPGA.(From baseline/randomization to Week 4)
- Change in Scalp Physician’s global assessment (ScPGA) at end of treatment compared to baseline.(At baseline/randomization and Week 4 post-randomization)
研究者
研究点 (16)
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