The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001028796
Ethics application status
Approved
Date submitted
10/09/2013
Date registered
16/09/2013
Date last updated
2/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of the Apitherapy in the treatment of recalcitrant localized plaque psoriasis and evaluation of Tumor Necrosis Factor-Alpha (TNF-a) serum level: Double blind randomized clinical trial.
Scientific title
Efficacy of the Apitherapy in the treatment of recalcitrant localized plaque psoriasis and evaluation of Tumor Necrosis Factor-Alpha (TNF-a) serum level: Double blind randomized clinical trial.
Secondary ID [1] 283181 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Localized psoriasis 290039 0
Condition category
Condition code
Skin 290416 290416 0 0
Dermatological conditions
Inflammatory and Immune System 290446 290446 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 287906 0
Treatment: Drugs
Comparator / control treatment
saline injection
Control group
Placebo

Outcomes
Primary outcome [1] 290441 0
To evaluate the therapeutic potential effect of Bee venom in recalcitrant localized Psoriasis, by assessing Physician Global Assessment (PGA) before and after treatment
Timepoint [1] 290441 0
To evaluate the therapeutic potential effect of Bee venom in recalcitrant localized Psoriasis at the end of 3 months of treatment
Primary outcome [2] 291836 0
To evaluate the therapeutic potential effect of Bee venom in recalcitrant localized Psoriasis at the end of 3 months of treatment. By assessing with physician global assessment (PGA).
Timepoint [2] 291836 0
To evaluate the therapeutic potential effect of Bee venom in recalcitrant localized Psoriasis at the end of 3 months of treatment
Secondary outcome [1] 304524 0
To detect the effect of Bee venom on the serum level of Tumor necrosis factor alpha (TNF-a).
Timepoint [1] 304524 0
To detect the effect of Bee venom on the serum level of Tumor necrosis factor alpha (TNF-a).by measuring serum level of (TNF-a) at the beginning and 12th week of treatment via polystyrene microplate ELISA

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5401 0
Egypt
State/province [1] 5401 0

Funding & Sponsors
Funding source category [1] 287928 0
Self funded/Unfunded
Name [1] 287928 0
self funded. the study funded by the authors themselves
the university will not fund the trial because of poor resources
Address [1] 287928 0
Faculty of Medicine, Suez Canal University, Department of Dermatology and Venereology, Ismailia 41511, Egypt.
Country [1] 287928 0
Egypt
Primary sponsor type
Individual
Name
Faculty of Medicine, Suez Canal University, prof. Atef Elakhras
Address
Faculty of Medicine, Suez Canal University, Department of Dermatology and Venereology, Ismailia 41511, Egypt.
Country
Egypt
Secondary sponsor category [1] 286654 0
Individual
Name [1] 286654 0
Ghada F. A. Mohammed
Address [1] 286654 0
Faculty of Medicine, Suez Canal University, Department of Dermatology and Venereology, Ismailia 41511, Egypt.
Country [1] 286654 0
Egypt

Ethics approval
Ethics application status
Approved

Summary
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.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42798 0
Dr Ghada F. A. Mohammed
Address 42798 0
Faculty of Medicine, Suez Canal University, Department of Dermatology and Venereology, Ismailia 41511, Egypt.
Country 42798 0
Egypt
Phone 42798 0
+206401112518631
Fax 42798 0
Email 42798 0
dr_ghada77@hotmail.com
Contact person for public queries
Name 42799 0
Dr Ghada F. A. Mohammed
Address 42799 0
Faculty of Medicine, Suez Canal University, Department of Dermatology and Venereology, Ismailia 41511, Egypt.
Country 42799 0
Egypt
Phone 42799 0
+206401112518631
Fax 42799 0
Email 42799 0
dr_ghada77@hotmail.com
Contact person for scientific queries
Name 42800 0
Prof Atef Ibrahim EL-Akhras
Address 42800 0
Faculty of Medicine, Suez Canal University, Department of Dermatology and Venereology, Ismailia 41511, Egypt.
Country 42800 0
Egypt
Phone 42800 0
+206401006096387
Fax 42800 0
Email 42800 0
Atef_Elakhras@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary