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临床试验/NCT05362188
NCT05362188已完成早期 1 期

Efficacy and Safety of Topical Nicotinamide in Treatment of Discoid Lupus Erythematosus

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Activity score

研究概览

简要总结

Cutaneous lupus erythematosus (CLE) is lupus affecting the skin. In this autoimmune disease, the body's immune system attacks healthy skin. There are 3 main types: Acute cutaneous lupus, Subacute cutaneous lupus, and Chronic cutaneous lupus ("discoid lupus"). Lupus most often appears between the ages of 20 and 50 years; it affects women more than men, and it may happen more in patients with a family history of lupus or other autoimmune diseases.

详细描述

DLE is the most common form of chronic cutaneous erythematosus and can occur as a localized form (80%) with lesions on the face, ears, and scalp or as disseminated DLE (20%) with lesions above and below the neck. The disseminated form of DLE, especially when involving the trunk, is associated with an increased risk of progression to SLE. It is unusual for discoid lesions to be present below the neck without lesions also being present above the neck. Occasionally, discoid lesions develop on mucosal surfaces, including the lips, nasal mucosa, conjunctivae, and genital mucosa. Some patients with discoid lesions exhibit a photodistribution. Sun exposure seems to play a role in the development of lesions.

For discoid lupus erythematosus without associated SLE (CDLE), the evidence does not show whether circulating inflammatory cells and autoantibodies are involved in the pathogenesis, but it is evident that the cutaneous inflammatory infiltrates are dominated by Th1.

The first morphological sign of DLE is a well-defined, annular erythematous patch or plaque of varying size followed by follicular hyperkeratosis, which is adherent to the skin. By removing the adherent scale, follicle-sized keratotic spikes similar to carpet tacks can be seen ("carpet tack sign"). The lesions slowly expand with active inflammation and hyperpigmentation at the periphery leaving depressed central atrophy and scarring, telangiectasia, and hypopigmentation. DLE can progress to irreversible scarring alopecia on the scalp. Although uncommon, a squamous cell carcinoma can develop in a longstanding discoid lesion.

A biopsy from the lesion for routine histologic examination is usually diagnostic of DLE. Atrophic epidermis, keratotic plugging of the follicles, hydropic degeneration of the basal cells, and patchy perivascular and perifollicular lymphocytic infiltrate are characteristic.

Early treatment of discoid lupus lesions may lead to the total clearing of skin lesions, but treatment failure results in permanent scarring. Hair loss, depressed scars, and pigmentary changes are often disfiguring, particularly in darker-skinned people. Some general measures, such as sun avoidance and liberal application of sunscreen, are encouraged because cutaneous lesions are known to be exacerbated by sunlight. Smoking cessation is encouraged, as this can increase DLE disease activity.

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
Triple (Participant, Care Provider, Investigator)

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: between 18 years and 65 years old
  • Patients clinically and histopathologically newly diagnosed as DLE
  • Patients clinically and histopathologically diagnosed with cutaneous lupus erythematosus that has not responded to treatment with hydroxychloroquine(200-400mg/day) plus corticosteroid at a dosage less than the equivalent of (0.5mg/kg/day) for the preceding two months or a longer period

排除标准

  • Age < 18 years old
  • Pregnant and lactating women
  • A history of treatments with multivitamins in the recent month
  • Soft tissue infection
  • Severe comorbidities including heart failure, respiratory failure
  • Acute severe infections such as cellulitis or a history of HBV or HCV

研究组 & 干预措施

Topical Nicotinamide 2%

Experimental

will receive topical nicotinamide 2%

干预措施: Nicotinamide Topical (Drug)

Topical Nicotinamide 4%

Experimental

will receive topical nicotinamide 4%

干预措施: Nicotinamide Topical (Drug)

Placebo

Placebo Comparator

Subjects will receive only cream/gel base without API for control

干预措施: Nicotinamide Topical (Drug)

结局指标

主要结局

Activity score

时间窗: from base line ( visit 0 ) to 1 , 2 respectively

A change in discoid lupus erythematosus activity score

Severity index

时间窗: from base line ( visit 0 ) to 1 , 2 respectively

A change in discoid lupus erythematosus severity index

次要结局

  • Response(2 months)
  • The dermatology life Quality Index score(2 months)
  • Remarkable response(2 months)

研究者

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

Ahmed Hassan Nouh MD

the principal investigator

Al-Azhar University

研究点 (1)

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