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

NCT ID: NCT06106230

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-04-15

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.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A:Bee venom phonophoresis + Conservative care

Bee venom phonophoresis + Conservative care (32 patients)

Group Type: EXPERIMENTAL

Bee venom phonophoresis

Intervention Type: 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

Group B:Bee venom topical application + Conservative care

Bee venom topical application + Conservative care (32 patients)

Group Type: EXPERIMENTAL

Bee venom phonophoresis

Intervention Type: 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

Group C:Conservative care

Control group Conservative care only (32 patients) Plain gel instead of BV gel plus off ultrasound (sham ultrasound) with medical treatment

Group Type: SHAM_COMPARATOR

Bee venom phonophoresis

Intervention Type: 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

Interventions

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

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

low intensity Ultrasound with bee venom gel

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MTI University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d

lectrurer of physical therapy for general surgery and dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Mohamed Ahmed Abdelhady

Cairo, , Egypt

Countries

Egypt

Related Links

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5031852/

Evaluation of Knee Proprioception and Factors Related to Parkinson's Disease

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5426262/

Quantitative Assessment of Proprioception Using Dynamometer in Incomplete Spinal Cord Injury Patients: A Preliminary Study

Other Identifiers

REC/2111/MTI.PT/2309292

Identifier Type: -

Identifier Source: org_study_id