An Open Labeled Exploratory Study to Evaluate the Application of Natural Lactic Acid Enriched Cream in Adults With Plaque Psoriasis
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 主要终点
- Physician Global Assessment (PGA) score
研究概览
简要总结
Psoriasis is a chronic and immune mediated skin disorder that presents with plaques of thickened, scaly skin. Up to 71% patients suffer from psoriasis, leading to high impact on their daily life. Plaque psoriasis is the most common type which causes thick, scaly patches of skin. Although the treatment of moderate-to-severe psoriasis has been improved with the new launched biologics, topical therapies continue to play a key role in the management of mild-to-moderate psoriasis. Up to 80% of patients of psoriasis use topical agents as their first-line therapy, including topical vitamin D analogs, corticosteroids, vitamin A analogs, and anthralin. There are well-documented concerns and limitations with current topical treatments. In this study, we propose a nature lactic acid enriched cream with a high safety profile as an alternative choice for patients with plaque psoriasis. Lactic acid is a natural moisturizing factor, which exists in healthy skin. It can efficiently prevent water loss from the skin and alleviate allergic reactions caused by dry skin. The moisturized function of lactic acid has made it became a commonly used additive in a wide variety of skincare products, such as lotion, cream, butter and spray. This product is rich in natural lactic acid generated by the fermentation of probiotics, and therefore can relieve skin itching caused by skin dryness, and resume the water-holding capability of the skin by removing abnormally proliferative stratum corneum as well as inducing collagen production. Importantly, this product is a steroid-free product with safety and without any induced adverse effects in use. This product is also can be a promising option other than steroids to be applied for the mitigation of recurrent symptoms in plaque psoriasis by resuming the water-retention ability of skin and rebuilding skin barrier function.
详细描述
I. Study Purpose
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Hypothesis: Natural lactic acid-enriched cream improves the Psoriasis Area and Severity Index scores in plaque psoriasis patients.
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Primary Objective: To assess the clinical efficacy of natural lactic acid-enriched cream for the proportion of subjects who achieve a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from Baseline in patients with plaque psoriasis.
- Secondary Objectives:
- To assess the safety of 12 week-treatment of natural lactic acid-enriched cream application, as determined by the count of serious and non-serious treatment-emergent adverse events (AEs) during the study period.
- To evaluate the clinical efficacy of natural lactic acid-enriched cream in subjects with plaque psoriasis.
- To assess the TEWL, transepidermal water loss of natural lactic acid-enriched cream.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects ages 20 to 65 years with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 6 months prior to the study.
- •Capable of giving written informed consent
- •BSA involvement ≥ 5% and ≤ 10%
- •A PGA score of 3 (moderate) at screening and baseline
- •One target plaque located on the trunk or proximal parts of extremities (excluding knees, elbows, and intertriginous areas) that is at least 3 (centimeter) cm х 3 cm in size at Screening and Baseline with a severity representative of the subject's overall disease.
- •Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study, including screening, during the treatment period, and for at least 4 weeks after the last exposure to study treatment
排除标准
- •Psoriasis other than plaque variant
- •Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chicken pox) skin infection within 1 week prior to the Baseline visit; chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the Baseline visit
- •Significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
- •Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 4 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's psoriasis
- •Use of any prohibited medication within the indicated period before the first dose of study drug:
- •Within a minimum of 5 half lives for biologic agents
- •Within 4 weeks for systemic immunosuppressive or immunomodulating agents, fumaric acid derivatives, vitamin D3 and analogs, retinoids, psolarens, corticosteroids, adrenocorticotropic hormone analogs, and tazarotene
- •2 weeks for immunizations with a live viral component
- •Drugs known to possibly worsen psoriasis, unless on a stable dose for > 12 weeks
- •With the exception of non medicated emollients, 1 week for topical treatments including corticosteroids, immunomodulators, anthralin (dithranol), vitamin D derivatives or coal tar
- •Any investigational product within 30 days, 5 half lives, or twice the duration of the biological effect of the study drug (whichever is longer) prior to first dose of study drug
- •Pregnant females or lactating females
- •Subjects have an allergic history of soybean and soybean derivatives.
- •History of sensitivity to the study drugs, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates the subject's participation in the study
结局指标
主要结局
Physician Global Assessment (PGA) score
时间窗: Week 12
Numbers of subjects who achieve a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2 grade improvement from Baseline at Week 12
次要结局
未报告次要终点