CTRI/2021/11/038146已完成3 期
A Three arm, multicenter, randomized, double blind, placebo and SOC-controlled study to evaluate the Safety and efficacy of Apremilasttopical gel, 2% w/w in adult patients with mild to moderate plaque psoriasis: Phase III clinical trial - NA
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 351
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Males or females, = 18 years of age at the time of signing the informed consent document.
- •2. Understand and voluntarily sign an informed consent document prior to any study related
- •assessments/procedures being conducted.
- •3. Able to adhere to the study visit schedule and other protocol requirements.
- •4. Diagnosis of chronic mild to moderate plaque psoriasis i.e., 6 point sPGA score of = 3 and PASI
- •score of = 10 for at least 10 months with multiple treatable areas (i.e. the lesion should not only
- •on the face, scalp, genitals or skin folds) which covers less than 10% of the total Body Surface
- •Area (BSA), and affected area on the limb and/or trunk = 1% BSA. Must be in general good
- •health (except for psoriasis) as judged by the investigator, based on medical history, physical
- •examination, and clinical laboratories.
- •5. Male subjects (including those who have had a vasectomy) who engage in activity in which
- •conception is possible must use barrier contraception (male latex condom or non-latex condom
- •NOT made out of natural [animal] membrane [for example, polyurethane]) while on
- •investigational product and for at least 28 days after the last dose of investigational product.
排除标准
- •1. Patients using topical psoriasis medications within the past 2 weeks, and those taking systemic (oral, intravenous, intramuscular, or intradermal) medications for psoriasis in the past 28 days, those using steroids, immune suppressive medications, and cyclooxygenase-2 anti-inflammatory drugs, and those using any medication conflicting with the product ingredients will also excluded from this study.
- •2. Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she participates in the study.
- •3. Any condition, including other inflammatory diseases or dermatologic conditions, which
- •confounds the ability to interpret data from the study, including other types of psoriasis (i.e., erythrodermic, guttate, inverse, or pustular psoriasis), other than plaque psoriasis.
- •4. Prior history of suicide attempt at any time in the subjects life time prior to signing the informed
- •consent and randomization, or major psychiatric illness requiring hospitalization within the last 3
- •years prior to signing the informed consent
- •5. Women planning to become pregnant within 90 days of the start of the study and pregnant or
- •lactating women or women not taking medically approved birth control were also excluded.
- •6. Active substance abuse or a history of substance abuse within 6 months prior to signing the
- •informed consent
- •7.Exclude the patients who exhibited weight loss greater than equal to 5% of initial body weight.
- •8. Patients participating in any other clinical trial will be excluded.
- •9. Prolonged sun exposure or use of tanning booths, which may confound the ability to interpret
- •data from the study.
- •10. Patients who are under treatment with apremilast and may include after wash out period.
- •11. In the opinion of the investigator, the subjects were not considered appropriate candidates.
研究者
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