None listed
Conditions
Brief summary
The interventional, randomized, placebo-controlled, parallel-group study was approved from the Suez Canal Research Ethical Committee. The study was carried out in Dermatology outpatient clinic, Suez Canal University Hospital for a period of 10 months in accordance with the guidelines of the Helsinki Declaration. Informed consent was obtained from all patients This randomized control trial study conducts to evaluate serum level of TNF-a and the efficacy and safety of using Apitherapy in order to find an effective and easy method for treating localized psoriasis. Aim of work It is a trial to evaluate Bee Venom Therapy (BVT) in localized psoriasis and to investigate its possible influence on serum level of tumor necrosis factor alpha (TNF- a). Study objectives * To evaluate the therapeutic potential effect of Bee venom in localized Psoriasis . * To detect the effect of Bee venom on the serum level of Tumor necrosis factor alpha (TNF-a). Study questions * Is the use of bee venom therapy effective in treatment of localized psoriasis? * Dose Bee venom therapy has effect on serum level of TNF –a? Hypotheses The Bee venom is effective in treatment of localized Psoriasis.
Interventions
All patients will tested for existing immunity by intradermal injection of 0.05 ml of drug [Epivac 'Registered Trademark' Bee Venom (Apis mellifera)The Holding Company for Biological Products and Vaccines] into the skin of left forearm. the one who negative for anaphylactic reaction, will have a standard dose of 0. 05 mL/cm2 around psoriatic lesion were administered intradermaly. Injections were spaced 1 cm apart. An insulin syringe with a small-bore needle (25 gauge) was used for accuracy of do
All patients will tested for existing immunity by intradermal injection of 0.05 ml of drug [Epivac 'Registered Trademark' Bee Venom (Apis mellifera)The Holding Company for Biological Products and Vaccines] into the skin of left forearm. the one who negative for anaphylactic reaction, will have a standard dose of 0. 05 mL/cm2 around psoriatic lesion were administered intradermaly. Injections were spaced 1 cm apart. An insulin syringe with a small-bore needle (25 gauge) was used for accuracy of dose measurement and ease of administration. The session carried on once weekly for 3 months in small doses starting with 0.05-0.1ml, and then increased gradually by 0.05 ml every other injection till reach a dose 1 ml every injection
Sponsors
Faculty of Medicine, Suez Canal University, prof. Atef Elakhras
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
*Patients diagnosed as recalcitrant localized psoriasis. *Patients aged 18 -60 years. *Both genders. *Stopping any topical or systemic treatment for psoriasis during the last 2 months.
Exclusion criteria
*Patient who had any allergic disorder. *Patient who had reactions to bee stings. *Patient who are responding well to conventional treatment. *Pregnancy and lactation. *Systemic diseases such as diabetes and cardiac diseases
Outcome results
None listed