CTRI/2026/03/106289尚未招募3 期
A Prospective, Randomized, Parallel group, Double-blind, Active-Controlled, Multi-centric, Two-arms, Phase III Study to Assess the Efficacy and Safety of Roflumilast 0.3% w/w cream Versus Calcipotriol 50 mcg cream in patients with Plaque Psoriasis.
Ms PURE CARE HEALTHCARE PVT LTD15 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2026年3月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 330
- 试验地点
- 15
研究概览
简要总结
This is a prospective, randomized, double blind, active controlled, multi centric Phase Three study to evaluate the efficacy and safety of Roflumilast cream compared with Calcipotriol cream in patients aged Twelve years and above with plaque psoriasis.
Approximately Three Hundred Thirty patients will be randomized in a One is to One ratio to receive either study treatment once daily for Sixteen weeks. The primary endpoint is the proportion of patients achieving Investigator Global Assessment success defined as clear or almost clear with at least Two grade improvement from baseline at Week Sixteen. Secondary endpoints include Psoriasis Area and Severity Index responses and safety assessments.
The study will be conducted in accordance with Good Clinical Practice and applicable regulatory guidelines in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects meeting the following criteria will be included in the study:
- •Male or female subjects aged 12 years or older, inclusive.
- •Clinical diagnosis of psoriasis vulgaris of at least 6 months duration, as determined by the Investigator.
- •Females of childbearing potential must have a negative pregnancy test at Screening Visit 1 and Baseline Visit
- •In addition, sexually active females of childbearing potential must agree to use at least one form of highly effective contraception throughout the trial.
- •In good health as judged by the Investigator, based on medical history, physical examination, biochemistry laboratory tests, haematology values, and urinalysis.
- •Subjects considered reliable and capable of adhering to the Protocol and visit schedule.
排除标准
- •Subjects will be excluded from the study for any of the following reasons:
- •Subjects with severe plaque psoriasis defined as an Investigator Global Assessment score of 4 at Screening or Baseline, or those requiring immediate systemic therapy as per the Investigator’s clinical judgment.
- •Subjects with known severe immunological diseases such as human immunodeficiency virus infection.
- •Any diagnosis of systemic sclerosis.
- •Subjects with current or untreated tuberculosis.
- •Subjects with active viral hepatitis, including hepatitis B or hepatitis C.
- •Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
- •Subjects with a history of chronic alcohol or drug abuse within 6 months prior to initiation of the investigational product.
- •Subjects with a current or past history of malignancy, with the exception of adequately treated basal cell carcinoma.
- •Subjects who have used topical prescription treatments for psoriasis within 2 weeks prior to randomization or who plan to use them during the study period.
- •Subjects who are currently receiving treatment with systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously, including erythromycin, ketoconazole, fluvoxamine, enoxacin, and cimetidine.
- •Subjects with a confirmed pregnancy at Screening or Baseline.
- •Subjects who plan to become pregnant within 6 months of study entry.
- •Subjects who are currently breastfeeding.
- •Subjects who plan to donate blood at any time during the study.
- •Subjects who are, in the Investigator’s opinion, unable or unlikely to complete the study or comply with the Protocol.
研究者
Dr Avinash Andhale
Vivotech Research Private Limited
研究点 (15)
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