Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202101485247187 Date of Approval: 19/01/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of Bee Venom Phonophoresis in Treatment of Plaque Psoriasis
Official scientific title Efficacy of bee venom phonophoresis in treatment of plaque psoriasis
Brief summary describing the background and objectives of the trial Approximately 75% of patients believe that psoriasis has had moderate to significant adverse effects on their quality of life, while suicide is considered in at least 20% of patients with psoriasis (Krueger et al., 2001). Recently, psoriasis has been proven as a risk factor for type 2 diabetes and heart disease. Also, joint arthritis, pulmonary disease, and insomnia are associated with psoriasis (Azfar et al., 2012). The bee venom (BV) has been used for an extended period as a therapeutic agent. It has been administered through injection by a syringe, directly from a bee sting, or injected into an acupuncture point-related disorder (Han et al., 2015). The evidence collected shows that BV has anti-inflammatory, atherosclerotic, and fibrotic properties (Zhang et al., 2018). For many psoriasis patients, topical treatment is sufficient and there may be no need for additional systemic medications. These medicinal products have serious side effects (Lebwohl & Ali, 2001). So it is important to search for safe, and natural topical treatment. Phonophoresis is a technique in which drugs, usually analgesic or anti-inflammatory drugs, are introduced into the subcutaneous tissues via intact skin by therapeutic ultrasound. In common inflammatory conditions, phonophoresis can provide a harmless and painless replacement for injections using numerous anti-inflammatory drugs (Kuntz et al., 2006).The development of effective methods to treat significant diseases, including skin diseases, is one of the priorities in the physical therapy field (Kruglov et al., 2012).Introducing Bee venom as a topical treatment or through therapeutic ultrasound as an alternative to injection was investigated in rare or no studies So this study was designed to evaluate the effectiveness of ultrasound enhanced-bee venom (bee venom phonophoresis) as a new treatment approach on plaque psoriasis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 16/01/2021
Actual trial start date
Anticipated date of last follow up 25/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Study group A 3 sessions per week 4 weeks An adequate layer of bee venom-mixed gel, under occlusive dressing (Duderm, ConvaTec) had been topically applied to the psoriatic areas for 30 min to allow area saturation with the mixture. Then, the occlusive dressing and residual gel were removed, and immediately, the ultrasonic applicator with a thin layer of sonic gel rubbed the area gently for 5 min/region with the following parameters: continuous mode, 1.5W/cm2 as intensity, 1 MHz as US frequency, and with 1.0 cm2 as an effective area of irradiation. 15
Experimental Group Study group B 3 sessions per week 4 weeks In the study group (B), the order of treatment was reversed as the ultrasonic applicator with a thin layer of sonic gel rubbed the area gently for 5 min/region using the same parameters applied in the group (A). Then, the residual gel was removed and for 30 min., an adequate layer of bee venom-mixed gel (0.2ml/cm2) closed off by occlusive dressing had been topically applied to the psoriatic areas. 15
Control Group Control group C 3 sessions per week 4 weeks In the control group C, the psoriatic area received only and for 30 min., an adequate topical layer of bee venom-mixed gel (0.2ml/cm2) closed off by occlusive dressing. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Patients' ages ranged from 20 to 50 years -They had moderate-grade plaque psoriasis in the upper and lower extremities -Disease duration ranged from 6 to 18 months Patients with diabetes, peripheral vascular diseases, acute viral diseases or a history of allergic skin, and dermatitis. - Pregnant patients and patients with contraindications to ultrasound Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/11/2020 Faculty of Physical Therapy Ethical Comitte Cairo University
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzayat street Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The Psoriasis Area Severity Index (PASI) was used to measure the severity of psoriasis (the largest patch of psoriasis or area with adjacent small patches in each region) as psoriasis locations were divided into the upper (U) and lower (L) extremities, the symptom score was calculated as the erythema (Er), infiltration (In), and desquamation (De) grades were determined on a scale as none for (zero), slight for (one), moderate for (two), severe for (three) and severe for (four) and the percentage score of each area (A) involved was calculated on a scale as follows; the score (0) for 0%, (1) for (1% - 9%), (2) for (10% - 29%),(3) for (30% - 49%), (4) for (50% - 69%), (5) for (70% - 89%), and score (6) for (90% - 100%). Taking into consideration that the area of upper limbs represents (0.2 ) of body surface area, while the area of lower limbs represents (0.4) of body surface area. Then, the following PASI formula was used to estimate total scores in the study The Psoriasis Area Severity Index scores = (0.2 (DeU+ErU+InU) AU + 0.4 (DeL+ErL+InL) AL) Baseline, and after 4 weeks of intervention
Secondary Outcome Ultrasonography with high resolution (40-MHz) was used to evaluate the skin thickness of the target area concerning a fixed point in the affected area, which was determined in relation to a landmark (acromion as a landmark for the arm, olecranon for the forearm, the greater trochanter for the thigh, and the patella was a landmark for the leg). Baseline, and after 4 weeks of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy Cairo University 7 Ahmed ELzayat St. Giza 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hesham Galal Mahran 7 Ahmed Elzayat st. Giza 11432 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy Cairo University 7 Ahmed Elzayat st. Giza 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hesham Mahran heshammahran75@yahoo.com +201030792492 7 Ahmed Elzayat st.
City Postal code Country Position/Affiliation
Giza 11432 Egypt Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Hesham Mahran heshammahran75@yahoo.com +201030792492 7 Ahmed Elzayat st.
City Postal code Country Position/Affiliation
Giza 11432 Egypt Assistant Professor
Role Name Email Phone Street address
Public Enquiries Hesham Mahran heshammahran75@yahoo.com +201030792492 7 Ahmed Elzayat st.
City Postal code Country Position/Affiliation
Giza 11432 Egypt Assistant Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I will share the results of this study within 6 months of the study completion regarding, psoriasis severity and skin thickness Clinical Study Report 6 month after the study completion The criteria will be accessed by the publication of the trial in an international journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information