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

Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06106230
• Other study ID #: REC/2111/MTI.PT/2309292
• Status: Completed
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: April 15, 2024

Study information

• Verified date: April 2024
• Source: MTI University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 15, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Combination Product:
• Bee venom phonophoresis
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

Locations

Country	Name	City	State
Egypt	Ahmed Mohamed Ahmed Abdelhady	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
MTI University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neutrophils / Lymphocyte Ratio (Neutrophil-to-Lymphocyte Ratio)	Ratio	base line after 12 weeks
Primary	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
Primary	(ESR) erythrocyte sedimentation rate	ESR	base line after 12 weeks
Secondary	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
Secondary	Isokinetic machine proprioceptive test	A dynamometer (System 3 Pro; Biodex Medical Inc., Shirley, NY, USA)	base line after 12 weeks

External Links

•   Evaluation of Knee Proprioception and Factors Related to Parkinson's Disease
•   Quantitative Assessment of Proprioception Using Dynamometer in Incomplete Spinal Cord Injury Patients: A Preliminary Study