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临床试验/CTRI/2016/11/007511
CTRI/2016/11/007511招募中Unknown

Assessment of Efficacy, Tolerability and Safety of Steroneo Skin Cream (Physalis Angulata Supercritical Extract) application for treatment of eczematous lesions: A Prospective, Open-label, Non-Comparative Study

Rehmat Clinic1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年6月9日最近更新:

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
To assess the efficacy of Steroneo Physalis Angulata Supercritical Extract application for treatment of eczematous lesions.

研究概览

简要总结

Dermatitis or eczema, is an inflammatory reaction of skin characterized by itchy, erythematous, vesicular, weeping, and crusting patches.(2) It is also commonly used to describe atopic dermatitis (AD) or atopic eczema.Global prevalence of eczema is about 3.5% with over 230 million people affected in 2010 (3.5% of the population).The lifetime clinician-recorded prevalence of eczema has been seen to peak in infancy, with female predominance of eczema presentations occurring during the reproductive period of 15–49 years. There is no known cure for eczema and the treatment aims at controlling symptoms by reducing inflammation and relieving itching. Moisturizing agents or emollients and topical steroids form the mainstay of management of eczema in most cases. Topical corticosteroids form the mainstay of treatment for many skin conditions. If used appropriately, they are safe and effective. However, on many occasions patients self-medicate thus increasing the risk of local adverse effects, poor clinical response and treatment failure. The most frequent adverse effects include atrophy, striae, rosacea, perioral dermatitis, acne, and purpura. Less frequent adverse effects include hypertrichosis, pigmentation alterations, delayed wound healing, and exacerbation of skin infections. Also, the steroids can cause effects such as immunosuppression, cell turn-over reduction, tissue atrophy, extracellular matrix degradation, drying and, as a consequence, premature and/or exacerbate aging which is a cause of concern. Physalis Angulata (Cutleaf Ground Cherry), a native plant to tropical America, now widely distributed throughout the tropical, subtropical and warm temperate regions. It is an erect, branched, annual plant growing from 10 - 100cm tall. It harvested from the wild for its edible fruit, and also for medicinal use. Physalis angulata is known for its antimalarial, anti-inflammatory and post-partum treating properties. It contains physalins and withanolides. Pharmacological studies have shown anti-parasitic, anti-inflammatory, antimicrobial, anti-nociceptive, antimalarial, anti-leishmanial, immunosuppressive, anti-asthmatic, diuretic, and antitumor activities

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Clinically diagnosed with eczematous lesions of any of the following types and requiring mild to moderate topical steroid therapy: •Atopic dermatitis •Contact dermatitis •Xerotic eczema •Nodular eczema •Seborrheic dermatitis •Neurocutaneous dermatitis (lichen simplex chronicus) •Drug eruptions, photo-dermatitis •Pruritus requiring topical corticosteroids Patients/parents who sign the written informed consent form Patients willing to and able to understand and comply with all study requirements.

排除标准

  • 1.Patients having any of the following conditions: •Lichen planus •Severe dermatitis requiring systemic corticosteroids •Infantile dermatitis 2.Patients requiring systemic corticosteroids on any form 3.Pregnant and lactating women 4.Patients with known hypersensitivity to any of the ingredients/excipients of the study cream 5.Any other condition, which in the opinion of the clinician/investigator, could interfere significantly with the treatment and assessment process 6.Use of any investigational therapy within 30 days prior to randomization 7.Patients not willing to provide written informed consent.

结局指标

主要结局

To assess the efficacy of Steroneo Physalis Angulata Supercritical Extract application for treatment of eczematous lesions.

时间窗: 12 weeks.

次要结局

  • Dermatology Life Quality Index would be assessed using a 10 item questionnaire by patients above 16 years of age(Reduction in number and size of lesions of eczema.)

研究者

发起方
Rehmat Clinic
申办方类型
Private hospital/clinic

研究点 (1)

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