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临床试验/NCT05555797
NCT05555797尚未招募4 期

Efficacy of Excimer Laser Combined With Either Topical Tazarotene or Topical Betamethasone Valerate Versus Excimer Laser Alone in Treatment of Localized Chronic Plaque Psoriasis; Clinical and Dermoscopic Study

Assiut University0 个研究点目标入组 30 人开始时间: 2022年10月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
30
主要终点
detection of improvement of psoriasis

研究概览

简要总结

Psoriasis is a chronic, immune-mediated disease that affects approximately 2% of the population. The development and exacerbation of psoriasis involve an interaction between multiple genetic and environmental risk factors.

详细描述

Psoriasis presents as well-circumscribed, erythematous plaques with an overlying silvery white scales. It has an effect on various aspects of life including mental health, productivity and relationships.

Topical therapies as corticosteroids and vitamin D3 analogs are first-line treatments for mild plaque psoriasis; which involves less than 3% of the body surface area (BSA). Moderate-to-severe plaque psoriasis is usually managed with phototherapy, systemic or biologic therapies .

The American Academy of Dermatology gives a strength recommendation for the use of combination therapies for treatment of psoriasis with superior efficacy to monotherapy .

The 308-nm excimer laser has been widely used for many dermatological diseases. In psoriasis, it shows an efficacy in the treatment of localised plaques especially on the knees and elbows.

It is indicated in moderate to severe psoriasis that affects <10% of the body surface. Areas such as nose, ears and palpebral region can be easily accessed using the laser. It induces lymphocytic apoptosis and decreases the proliferation rate of keratinocytes . There are multiple protocols that evaluate the clinical response to Excimer laser; the induration protocol, the minimal erythema dose and the minimal blistering dose.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: ≥18 years.
  • Pattern: Patients with chronic plaque psoriasis not exceeding 10% of the body surface area.

排除标准

  • History of retinoid use either topical or systemic in the previous 16 weeks, phototherapy or topical psoriasis treatment within the last 4 weeks.
  • Allergy to any ingredients of tretinoin or betamethasone drugs.
  • Renal, hepatic disease, cardiovascular , Immunosuppressive therapy, endocrine and blood disease or mental illness.
  • Pregnancy, breast-feeding or women planning to become pregnant within 3 months.
  • Psoriasis exceeding 10% of body surface area or other severe types of psoriasis requiring systemic treatment.
  • Patients with other diseases and requiring treatment that would affect the study

研究组 & 干预措施

group of patients with psoriasis vulgaris

Experimental

in each patient lesions will be divided into 3 groups; Group 1: treated with Excimer laser alone(1-2 sessions/ week for 12 sessions according to induration protocol*).

Group 2: treated with Excimer laser combined with topical tazarotene gel 0.1% Group3: treated with Excimer laser combined with topical betamethasone valerate ointment 0.1%

干预措施: 308nm Excimer laser (Device)

group of patients with psoriasis vulgaris

Experimental

in each patient lesions will be divided into 3 groups; Group 1: treated with Excimer laser alone(1-2 sessions/ week for 12 sessions according to induration protocol*).

Group 2: treated with Excimer laser combined with topical tazarotene gel 0.1% Group3: treated with Excimer laser combined with topical betamethasone valerate ointment 0.1%

干预措施: Tazarotene Topical Gel (Drug)

group of patients with psoriasis vulgaris

Experimental

in each patient lesions will be divided into 3 groups; Group 1: treated with Excimer laser alone(1-2 sessions/ week for 12 sessions according to induration protocol*).

Group 2: treated with Excimer laser combined with topical tazarotene gel 0.1% Group3: treated with Excimer laser combined with topical betamethasone valerate ointment 0.1%

干预措施: Betamethasone Valerate (Drug)

结局指标

主要结局

detection of improvement of psoriasis

时间窗: 3 months

detection of improvement of psoriasis in response to excimer laser alone versus its combination with either topical tazarotene gel or betamethasone valerate ointment

次要结局

  • dermoscopic role(3 months)

研究者

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

Aliaa Effat Saied Sayed

Principal Investigator

Assiut University

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