Efficacy and Safety of Mesobotox as a Potential New Therapeutic Modality of Psoriasis Vulgaris in Comparison/Combination With Topical Calcineurin Inhibitor
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- To evaluate the efficacy and safety of Mesobotox for treatment of plaque psoriasis as a monotherapy versus its combination with a topical Calcineurin inhibitor 0.03% ointment and topical Calcineurin inhibitor 0.03% ointment alone.
研究概览
简要总结
Psoriasis is a systemic chronic relapsing immune-mediated disease which often requires a long-term therapy. Psoriasis occurs in around 2-3% of the total global population. In Egypt, the prevalence of psoriasis ranges between 0.19% and 3%.
Besides, it could have profound implications on the patients' psychological state and quality of life.
It is presented by erythematous, scaly plaques over the preferred sites. The pathogenesis of this highly complex disease is still far from being fully understood. Keratinocytes' hyperproliferation and immune system dysfunctions are well recognized contributors, with numerous treatments targeting these unique immunologic dysfunctions.
详细描述
Neurogenic inflammation has been suggested as an etiopathogenic factor of psoriasis. Previous reports revealed an increased concentration of nerve fibers as well as a high level of neuropeptides of cutaneous sensory nerve origin, primarily Substance P and calcitonin gene-related peptide (CGRP).
Some investigators reported improvement of psoriatic plaques after injuries that compromised peripheral nerves. Hence, it was postulated that cutaneous sensory afferent neurons are involved in the etiopathogenesis of psoriasis and may serve as a potential therapeutic target.
Substance P (SP) is a neuropeptide of sensory nerve origin that can influence the immune cell functions and the inflammatory responses in psoriasis. By binding to NK1R on T cells, SP can stimulate Th17 cell differentiation and production of interleukin-17A cytokine (IL-17A). IL-17A is a key effector cytokine in psoriasis, by releasing several pro-inflammatory cytokines, such as TNF alpha, stimulating abnormal keratinocytes' proliferation and promoting angiogenesis.
Topical drug therapy is the cornerstone of the treatment of mild to moderate psoriasis. It offers a direct skin targeting and avoids systemic adverse events. Several topical therapies are currently available for the treatment of psoriasis such as topical steroids, topical vitamin D3 analogues e.g. Calcipotriol, tar, anthraline, topical calcineurin inhibitors and tazarotene.
Tacrolimus, formerly known as FK506, is a macrolide antibiotic possessing immunosuppressive properties. Tacrolimus disrupts the intracellular activation of T-lymphocytes and inhibits the ability of calcineurin to regulate gene transcription. Thus, tacrolimus intervenes at an early stage of T-cell activation, leads to several secondary consequences providing effective and therapeutically efficient results to overcome problems associated with psoriatic skin disease.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical diagnosis of mild to moderate psoriasis vulgaris
- •Patients who stopped any systemic therapy or phototherapy for at least 3 months and topical therapy for at least 4 weeks prior to enrollment.
排除标准
- •• Psoriasis vulgaris involving > 10% of the body surface area, pustular or erythrodermic psoriasis.
- •Patients with neuromuscular disease or history of epilepsy.
- •Pregnant or lactating females.
- •Patients with any current dermatological disease.
- •Patients with any current systemic disease.
研究组 & 干预措施
Botox group
Patients will receive a single intradermal injection of Mesobotox as a monotherapy.
Botulinum toxin injection: Botox injections will be intradermal. Concentration will be 100 U to be diluted with 5-ml sterile physiological sodium chloride solution. Each patient will receive individual injections of 1 U using a grid with points set at a distance of 1 cm apart. Up to two plaques per patient will be selected, whose diameter would not exceed 5-10 cm2. Each patient will receive a single BoNT-A injection
干预措施: Botulinum Toxin-A (Drug)
Botox and Tacrolimus group
Patients will receive a single intradermal injection of Mesobotox of the same dilution followed by topical application of Tacrolimus 0.03% ointment twice daily for 3 months.
干预措施: Botulinum Toxin-A (Drug)
Botox and Tacrolimus group
Patients will receive a single intradermal injection of Mesobotox of the same dilution followed by topical application of Tacrolimus 0.03% ointment twice daily for 3 months.
干预措施: Tacrolimus (Drug)
Tacrolimus group
Patients will apply Tacrolimus (0.03%) as a monotherapeutic twice daily for 3 months
干预措施: Tacrolimus (Drug)
结局指标
主要结局
To evaluate the efficacy and safety of Mesobotox for treatment of plaque psoriasis as a monotherapy versus its combination with a topical Calcineurin inhibitor 0.03% ointment and topical Calcineurin inhibitor 0.03% ointment alone.
时间窗: 6 months
This will be evaluated by measuring the (Psoriasis severity (TES) score) which is a physician-based, four-point scoring system in which the thickness, erythema, and scales within each plaque will be rated from 0 (none) to 3 (severe) to evaluate the therapeutic outcome within different groups before and after treatment.
次要结局
- To explore the treatment effects on the immunohistochemical features of psoriasis.(2 months)
- To explore the treatment effects on the histopathological features of psoriasis.(2 months)
研究者
SNIsrael
principal investigator
Assiut University