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Completed

NCT Number: NCT06106230

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

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.

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Mohamed Ahmed Abdelhady

Cairo, 11571, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bee venom phonophoresis

Combination Product

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

Other names: low intensity Ultrasound with bee venom gel

Primary outcomes

  1. Neutrophils / Lymphocyte Ratio (Neutrophil-to-Lymphocyte Ratio)

    Time frame: base line after 12 weeks

    Ratio

  2. C-reactive protein (CRP)

    Time frame: base line after 12 weeks

    A C-reactive protein (CRP) test measures the level of C-reactive protein in your blood.

  3. (ESR) erythrocyte sedimentation rate

    Time frame: base line after 12 weeks

    ESR

Secondary outcomes

  1. PASI score

    Time frame: base line after 12 weeks

    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

  2. Isokinetic machine proprioceptive test

    Time frame: base line after 12 weeks

    A dynamometer (System 3 Pro; Biodex Medical Inc., Shirley, NY, USA)

Sponsors and collaborators

Lead sponsor

MTI University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 30, 2023
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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