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

NCT06106230 | Completed

• 1 other identifier: REC/2111/MTI.PT/2309292
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• PASI score

  base line after 12 weeks

• Isokinetic machine proprioceptive test

  base line after 12 weeks

Study Arms (3)

Group A:Bee venom phonophoresis + Conservative care

EXPERIMENTAL

Bee venom phonophoresis + Conservative care (32 patients)

Combination Product: Bee venom phonophoresis

Group B:Bee venom topical application + Conservative care

EXPERIMENTAL

Bee venom topical application + Conservative care (32 patients)

Combination Product: Bee venom phonophoresis

Group C:Conservative care

SHAM COMPARATOR

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

Interventions

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

Also known as: low intensity Ultrasound with bee venom gel

Group A:Bee venom phonophoresis + Conservative care; Group B:Bee venom topical application + Conservative care; Group C:Conservative care

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

Ahmed Mohamed Ahmed Abdelhady

Cairo, 11571, Egypt

Location

Related 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lectrurer of physical therapy for general surgery and dermatology

Model Details: randomize controlled trial

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: January 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: April 15, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)