CTRI/2024/07/071444招募中3 期
A Randomized, Phase III, Three-Parallel Arm, Assessor-Blind, Active and Placebo Controlled Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of AKP02G2 Cutaneous Spray versus Enstilar Cutaneous Foam in Subjects with Mild to Moderate Psoriasis.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Lipidor AB
- 入组人数
- 294
- 试验地点
- 15
- 主要终点
- Percentage change in Psoriasis area and severity index (PASI) score from randomization/baseline to the end of treatment.
研究概览
简要总结
This phase III study has been designed to compare efficacy and safety of Test product (AKP02G2 cutaneous spray) of Lipidor AB with reference product (Enstilar cutaneous foam) of LEO Pharma in subjects with mild to moderate psoriasis and the impact of this therapy in their quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Investigator 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 subject aged greater than 18 years.
- •A clinical diagnosis of stable (at least 6 months) psoriasis vulgaris on body, or body and scalp, involving 5 to 10 percent of body surface area (BSA) and PASI ≤ 10., that does not include the face, axilla and groin areas.
- •Mild or moderate Psoriasis on Physician Global Assessment (PGA) score (grade
- •A plaque elevation of at least moderate severity (grade ≥ 3) at the target lesion site. The most severe lesion at randomization/baseline should be identified as the target lesion.
- •Subject must be willing to provide written informed consent.
- •Subject must be willing and able to understand and can comply with study requirements, apply the medication as instructed and be able to complete the study.
- •Subject must be in general good health as judged by the Investigator, based on medical history and physical examination.
排除标准
- •Subject with history of hypersensitivity to betamethasone or calcipotriol or any component of the test or reference product or placebo.
- •Current diagnosis of unstable forms of psoriasis in the treatment area including guttate, erythrodermic, exfoliative, or pustular psoriasis.
- •Subject with diagnosis of mild to moderate psoriasis only in the scalp area.
- •Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris (e.g., atopic dermatitis, contact dermatitis, tinea corporis and seborrheic dermatitis).
- •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.
- •Subject with psoriasis lesions predominantly on palms and soles or palmo-plantar area.
- •Subject with the diagnosis pustulosis palmo-plantaris.
- •Subject in need of systemic treatment.
- •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 within one month prior to randomization/baseline.
- •Females who are pregnant, nursing, or planning a pregnancy.
- •Females of childbearing potential who do not agree to utilize an adequate form of contraception.
- •Current significant medical problems that, in the discretion of the investigator, would put the subject at significant risk.
- •Use of any investigational drug within 4 weeks prior to randomization, or five 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.
- •Use of biologic or targeted treatment for psoriasis (e.g., infliximab, adalimumab, alefacept or JAK inhibitors) within six months prior to randomization/baseline.
- •Use of: a) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or b) oral retinoids, within two months prior to randomization/baseline.
- •Use of: a) systemic steroids, b) systemic antibiotics, c) other systemic anti-psoriatic treatment, d) PUVA therapy, e) UVB therapy, or f) systemic anti-inflammatory agents, within one month prior to randomization/baseline.
- •Use of: a) topical anti-psoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriol, tazarotene), b) topical corticosteroids, or c) topical retinoids, within 2 weeks prior to randomization/baseline.
- •Use of medicated shampoos with possible effect on psoriasis.
- •Subject with positive serology tests like HIV, HCV & HBsAg.
- •Any other condition that, in the Investigator’s judgment, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
结局指标
主要结局
Percentage change in Psoriasis area and severity index (PASI) score from randomization/baseline to the end of treatment.
时间窗: [Time Frame: From randomization/baseline to Week 4 (Day 29±4)]
次要结局
- a. Percentage change in Psoriasis scalp severity index (PSSI) scores from baseline to end of treatment.(b. Change in Physician’s global assessment (PGA) at end of treatment compared to baseline)
研究者
Dr Dharmesh Domadia
Cliantha Research
研究点 (15)
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