Bee Venom Phonophoresis on Mild to Moderate Localized Plaque Psoriasis on Knee Joint

Study Overview
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Brief Summary
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Chronic plaque psoriasis, or psoriasis vulgaris, is a chronic inflammatory skin disease characterized by well demarcated, erythematous, scaly plaques on the extensor surfaces of the body and scalp. The lesions may occasionally itch or sting, and may bleed when injured. Dystrophic nail changes or nail pitting are found in more than one third of people with chronic plaque psoriasis, and psoriatic arthropathy occurs in 1% to more than 10%. The condition waxes and wanes, with wide variations in course and severity among individuals.

Detailed Description
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Apitherapy is an alternate therapy that relies on the usage of honeybee products, most importantly bee venom for the treatment of many human diseases. The venom can be introduced into the human body by manual injection or by direct bee stings. Bee venom contains several active molecules such as peptides and enzymes that have advantageous potential in treating inflammation and central nervous system diseases, such as Parkinson's disease, Alzheimer's disease, and amyotrophic lateral sclerosis. Moreover, bee venom has shown promising benefits against different types of cancer as well as anti-viral activity, even against the challenging human immunodeficiency virus (HIV). Many studies described biological activities of bee venom components and launched preclinical trials to improve the potential use of apitoxin and its constituents as the next generation of drugs. Chronic plaque psoriasis is the most common form of psoriasis, accounting for more than 80% of cases. It is a chronic relapsing and remitting condition that presents as symmetrical, well-demarcated, erythematous thickened plaques with overlying silver scales. Appearance can vary depending on skin colour, ranging from pink on lighter skin to brown, purple, or grey on darker skin. It commonly affects the extensor surfaces (elbows and knees), scalp, trunk, and gluteal fold, but may arise on any part of the body. Plaques may coalesce to involve extensive areas of the skin, especially on the trunk and limbs.

Official Title
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Bee Venom Phonophoresis on Mild to Moderate Localized Plaque Psoriasis on Knee Joint

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Combination Product: Bee venom phonophoresis


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Symmetrical mild-to-moderate chronic plaque psoriasis Chronic stable plaque psoriasis Bilateral lesions of approximately 25 cm² Had not been receiving any treatment for at least one month. Those with infection or malignancy and/or subjects who had undergone major surgery in the past 6 months were not included in the study. Patients that had not undergone systemic treatment for psoriasis during the previous 3 months were included in the study age 20 - 50 with mild to moderate knee plaque psoriasis Symmetrical plaque psoriasis PASI score affected < 20 BSA of knee involvement : 2% to 20% Exclusion criteria Patients with malignant tumors, those diagnosed with psoriatic arthritis or any other systemic inflammatory disease, or those using medication were excluded from the study. Pregnancy Receiving steroid preparations topical or UVB therapy within previous 4 wks Systemic corticosteroids, PUVA, or laser phototherapy within previous 4 wks Other systemic therapies or biologicals within previous 3 wks Widespread psoriasis Hypercalcaemia Liver or renal disease

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomize controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A:Bee venom phonophoresis + Conservative care<br>Bee venom phonophoresis + Conservative care (32 patients) | Combination Product: Bee venom phonophoresis<br>* Bee venom gel preparation with low freq ultrasound Bee venom solution (100 mg/mL) that was prepared and preserved at the correct temperature was purchased from the Egyptian Organization for Biological Products & Vaccines (Vacsera). The solution was a mix of a crude form of BV dissolved in sterile normal saline with a concentration ratio of 1:1 vol/vol. Then, the BV gel was prepared at the laboratories of the Faculty of Pharmacy, Modern University, Cairo, Egypt, by dissolving the previous mixture in 10% propylene glycol, followed by the addition of 0.01% butylparaben. To make bee venom gel, the resulting mixture was mixed with the matrix. The BV gel had a homogeneous and translucent appearance and a pH of 7.53. There was no discoloration, phase separation, or off-putting odor. Stratification was not observed after 30 min of centrifugation at 2,500 rpm at 25◦C, used with low frequency ultrasound Device: low intensity ultrasound<br>* Other names: low intensity Ultrasound with bee venom gel;|
| Experimental: Group B:Bee venom topical application + Conservative care<br>Bee venom topical application + Conservative care (32 patients) | Combination Product: Bee venom phonophoresis<br>* Bee venom gel preparation with low freq ultrasound Bee venom solution (100 mg/mL) that was prepared and preserved at the correct temperature was purchased from the Egyptian Organization for Biological Products & Vaccines (Vacsera). The solution was a mix of a crude form of BV dissolved in sterile normal saline with a concentration ratio of 1:1 vol/vol. Then, the BV gel was prepared at the laboratories of the Faculty of Pharmacy, Modern University, Cairo, Egypt, by dissolving the previous mixture in 10% propylene glycol, followed by the addition of 0.01% butylparaben. To make bee venom gel, the resulting mixture was mixed with the matrix. The BV gel had a homogeneous and translucent appearance and a pH of 7.53. There was no discoloration, phase separation, or off-putting odor. Stratification was not observed after 30 min of centrifugation at 2,500 rpm at 25◦C, used with low frequency ultrasound Device: low intensity ultrasound<br>* Other names: low intensity Ultrasound with bee venom gel;|
| Sham Comparator: Group C:Conservative care<br>Control group Conservative care only (32 patients) Plain gel instead of BV gel plus off ultrasound (sham ultrasound) with medical treatment | Combination Product: Bee venom phonophoresis<br>* Bee venom gel preparation with low freq ultrasound Bee venom solution (100 mg/mL) that was prepared and preserved at the correct temperature was purchased from the Egyptian Organization for Biological Products & Vaccines (Vacsera). The solution was a mix of a crude form of BV dissolved in sterile normal saline with a concentration ratio of 1:1 vol/vol. Then, the BV gel was prepared at the laboratories of the Faculty of Pharmacy, Modern University, Cairo, Egypt, by dissolving the previous mixture in 10% propylene glycol, followed by the addition of 0.01% butylparaben. To make bee venom gel, the resulting mixture was mixed with the matrix. The BV gel had a homogeneous and translucent appearance and a pH of 7.53. There was no discoloration, phase separation, or off-putting odor. Stratification was not observed after 30 min of centrifugation at 2,500 rpm at 25◦C, used with low frequency ultrasound Device: low intensity ultrasound<br>* Other names: low intensity Ultrasound with bee venom gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutrophils / Lymphocyte Ratio (Neutrophil-to-Lymphocyte Ratio) | Ratio | base line after 12 weeks | 
| C-reactive protein (CRP) | A C-reactive protein (CRP) test measures the level of C-reactive protein in your blood. | base line after 12 weeks | 
| (ESR) erythrocyte sedimentation rate | ESR | base line after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI score | Psoriasis area severity index (PASI), which evaluates the degree of erythema, induration, and desquamation in the affected body areas, is one of the most commonly used scales to classify disease severity | base line after 12 weeks | 
| Isokinetic machine proprioceptive test | A dynamometer (System 3 Pro; Biodex Medical Inc., Shirley, NY, USA) | base line after 12 weeks |