Clinical trial NCT06106230: Bee Venom Phonophoresis on Mild to Moderate Localized Plaque Psoriasis on Knee Joint
Official title: Bee Venom Phonophoresis on Mild to Moderate Localized Plaque Psoriasis on Knee Joint
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plaque Psoriasis
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomize controlled trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Neutrophils / Lymphocyte Ratio (Neutrophil-to-Lymphocyte Ratio)
timeFrame: base line after 12 weeks
measure: C-reactive protein (CRP)
timeFrame: base line after 12 weeks
measure: (ESR) erythrocyte sedimentation rate
timeFrame: base line after 12 weeks
Secondary outcomes:
measure: PASI score
timeFrame: base line after 12 weeks
measure: Isokinetic machine proprioceptive test
timeFrame: base line after 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Mohamed Ahmed Abdelhady
Study officials:
References: