Plaque PsoriasisNCT06106230
Bee Venom Phonophoresis on Mild to Moderate Localized Plaque Psoriasis on Knee Joint
A study testing Bee venom phonophoresis in people with Plaque Psoriasis, run by MTI University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Bee venom phonophoresis
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- age 20 - 50 with mild to moderate knee plaque psoriasis
- Symmetrical plaque psoriasis
- PASI score affected < 20
- BSA of knee involvement : 2% to 20%
Who cannot join
- 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
Show all 9Show fewer
- Widespread psoriasis
- Hypercalcaemia
- Liver or renal disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Bee venom phonophoresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bee venom phonophoresisCombination product
Also called low intensity Ultrasound with bee venom gel
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
| Study group | Role | What they receive |
|---|---|---|
| Group A:Bee venom phonophoresis + Conservative care | Experimental | Bee venom phonophoresis + Conservative care (32 patients) Receives: Combination Product: Bee venom phonophoresis |
| Group B:Bee venom topical application + Conservative care | Experimental | Bee venom topical application + Conservative care (32 patients) Receives: 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 Receives: Combination Product: Bee venom phonophoresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophils / Lymphocyte Ratio (Neutrophil-to-Lymphocyte Ratio)
Ratio
Measured: 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.
Measured: base line after 12 weeks
(ESR) erythrocyte sedimentation rate
ESR
Measured: base line after 12 weeks
Secondary outcomes (2)
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
Measured: base line after 12 weeks
Isokinetic machine proprioceptive test
A dynamometer (System 3 Pro; Biodex Medical Inc., Shirley, NY, USA)
Measured: base line after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Jan 2024
- Primary completion1 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomize controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106230
- Sponsor's protocol ID
- REC/2111/MTI.PT/2309292
- Status last verified
- Apr 2024
- First submitted
- 24 Oct 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bee Venom Phonophoresis on Mild to Moderate Localized Plaque Psoriasis on Knee Joint
- ClinicalTrials.gov ID
- NCT06106230
- Acronym / sponsor ID
- REC/2111/MTI.PT/2309292
- Conditions
- Plaque Psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- randomize controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group A:Bee venom phonophoresis + Conservative care | Experimental | Combination Product: Bee venom phonophoresisBee venom phonophoresis + Conservative care (32 patients) |
| Group B:Bee venom topical application + Conservative care | Experimental | Combination Product: Bee venom phonophoresisBee venom topical application + Conservative care (32 patients) |
| Group C:Conservative care | Sham comparator | Combination Product: Bee venom phonophoresisControl group Conservative care only (32 patients) Plain gel instead of BV gel plus off ultrasound (sham ultrasound) with medical treatment |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bee venom phonophoresisAlso: low intensity Ultrasound with bee venom gelBee 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 | Combination product | Group A:Bee venom phonophoresis + Conservative care, Group B:Bee venom topical application + Conservative care, Group C:Conservative care |
Primary outcome
Neutrophils / Lymphocyte Ratio (Neutrophil-to-Lymphocyte Ratio)
Time frame: base line after 12 weeks
Ratio
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.
(ESR) erythrocyte sedimentation rate
Time frame: base line after 12 weeks
ESR
2 secondary outcomes
PASI score
Time frame: base line after 12 weeks
Isokinetic machine proprioceptive test
Time frame: base line after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Evaluation of Knee Proprioception and Factors Related to Parkinson's DiseaseLink provided by the sponsor.
- Quantitative Assessment of Proprioception Using Dynamometer in Incomplete Spinal Cord Injury Patients: A Preliminary StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bee venom phonophoresis in people with Plaque Psoriasis, run by MTI University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophils / Lymphocyte Ratio (Neutrophil-to-Lymphocyte Ratio) (time frame: base line after 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.