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临床试验/NCT06015152
NCT06015152已完成不适用

Comparison Of The Efficacy Of Tazarotene 0.045% Versus Halobetasol Propionate 0.01% Lotion For the Treatment of Scalp Psoriasis

Jinnah Postgraduate Medical Centre1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
The efficacy of Tazarotene 0.045% in Scalp Psoriasis

研究概览

简要总结

Psoriasis is a serious, immune-driven illness that affects around 2% of the population and has a wide range of clinical manifestations 1-3 . Many patients have localized illness, and topical therapy can be an important part of treatment.

tazarotene is the first receptor-selective retinoid for the topical treatment of plaque psoriasis. On application, tazarotene is rapidly hydrolyzed to its main metabolite, tazarotenic acid, which binds to retinoic acid receptors (RARs) in the nucleus. Tazarotenic acid selectively binds to RARs b and g . The predominant type of RAR expressed in the human epidermis is RAR, indicating that it may be an important mediator of retinoid action in skin. .

详细描述

Topical Corticosteroids is commonly used in situations of mild to moderate disease severity. However, long-term safety is still an issue, especially when utilizing stronger formulations,which come with a higher risk of local cutaneous adverse events (AEs). Telangiectasia, suppression of the hypothalamic-pituitary-adrenal (HPA) axis, and skin shrinkage are some of these negative consequences. By regulating gene transcription, tazarotene normalizes abnormal keratinocyte differentiation, reduces epidermal hyperproliferation, and decreases inflammation, the three pathogenic factors in psoriasis, thereby producing a more normal expression of skin differentiation in psoriatic lesions

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 30-50 years of age, either gender presenting with scalp psoriasis as per operational definition will be included in the study.

排除标准

  • pustular psoriasis or had used phototherapy, photochemotherapy, or systemic psoriasis therapy within the last four weeks (or biologics within the last three months).
  • Used topical treatment within 14 days prior to the baseline visit or who were diagnosed with skin conditions that would interfere with the interpretation of results were also excluded.
  • pregnant women, women attempting to become pregnant, lactation

研究组 & 干预措施

GROUP A Tazarotene 0.045%

Experimental

Topical tazarotene 0.045% and halobetasol Propionate 0.01% . TAZ is the first receptor-selective retinoid used externally to treat plaque psoriasis . The major metabolite of tazarotene, tazarotenic acid, is quickly formed after application and binds to retinoic acid receptors (RARs) in the nucleus. Tazarotenic acid has a weak affinity for retinoid X receptors and prefers to bind to RARs b and g.

Halobetasol propionate is a medication used to treat scalp psoriasis. It is a form of topical corticosteroid, which means it works by suppressing the immune system and reducing inflammation.

干预措施: Tazarotene 0.045% Topical Application Lotion [ARAZLO] (Drug)

GROUP B Halobetasol Propionate 0.01%

Experimental

Topical tazarotene 0.045% and halobetasol Propionate 0.01% . TAZ is the first receptor-selective retinoid used externally to treat plaque psoriasis . The major metabolite of tazarotene, tazarotenic acid, is quickly formed after application and binds to retinoic acid receptors (RARs) in the nucleus. Tazarotenic acid has a weak affinity for retinoid X receptors and prefers to bind to RARs b and g.

Halobetasol propionate is a medication used to treat scalp psoriasis. It is a form of topical corticosteroid, which means it works by suppressing the immune system and reducing inflammation.

.

干预措施: Tazarotene 0.045% Topical Application Lotion [ARAZLO] (Drug)

结局指标

主要结局

The efficacy of Tazarotene 0.045% in Scalp Psoriasis

时间窗: Efficacy will be assessed after 02 weeks

Efficacy will be assessed by using Investigator's Global Assessment score for scalp psoriasis which is typically a 5-point scale from 0 to 4, with 0 = Clear/No Disease, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4 = Severe. Mean diference of IGA score before and after treatment will be calculated

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Nazia Jabeen

Principal Investigator

Jinnah Postgraduate Medical Centre

研究点 (1)

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