Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201704002194318 Date of Approval: 11/04/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assessment of Botulinum Toxin Type A in the Treatment of Hand Eczema
Official scientific title Assessment of Botulinum Toxin Type A in the Treatment of Hand Eczema
Brief summary describing the background and objectives of the trial Hand eczema is a common and distressing condition which poses therapeutic challenge for the dermatologist, and deserves special consideration. The treatment measures of hand eczema includes avoidance of irritants, frequent application of emollients, topical steroids , topical immunosuppressants , topical hand PUVA , oral psoralen phototherapy(PUVA), UVB therapy, radiotherapy, oral alitretinoin and ciclosporin. A couple of studies, have shown that botulinum toxin type A (BTXA) is an effective method of therapy in dyshidrotic hand eczema as it is a potent neurotoxin that blocks the release of acetylcholine from overactive cholinergic nerve fibers, this will denervate eccrine sweat glands and reduce excessive sweating. Additionally, it inhibits substance P release, which might explain its antipruritic activity. Another study showed beneficial effects for BTXA in treatment of lichen simplex chronicus lesions on the back extending the benefit of BTXA to eczemas not associated with hyperhidrosis. The aim of this study is to evaluate the efficacy and tolerability of botulinum toxin type A in the treatment of hand eczema. Its impact on patients¿ quality of life will also be assessed.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Hand Eczema,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/04/2017
Actual trial start date 15/04/2017
Anticipated date of last follow up 15/10/2017
Actual Last follow-up date 15/10/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 Permuted block randomization (variable block size) Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group BTXA minimal of 50 units of BTXA Once topical corticosteroids + intradermal palmar injection of a minimal of 50 units of BTXA 30
Control Group Standard 15 gm of 0.1 g/100 g betamethasone per week Twice daily Topical corticosteroids 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Active symptomatic palmar hand eczema. Bilateral involvement. Skin infection at the site of injection. History of use of botulinum toxin in the last 4 months. Pregnancy, lactation in females. Any contraindication to botulinum toxin injection including associated disorder that may affect the neuromuscular function like myasthenia gravis and Lambert-Eaton disease. History of previous allergy to BTXA. 18 Year(s) 70 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 29/06/2016 IRB, Faculty of Medicine, Alexandria University
Ethics Committee Address
Street address City Postal code Country
Sultan Hussein Street, Azarita Alexandria 21519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual linear analog scale of pruritus. at baseline at the third day, end of 1st week, 4th week then monthly for a whole period of 6 months.
Secondary Outcome Hand eczema severity index at baseline at the third day, end of 1st week, 4th week then monthly for a whole period of 6 months.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dermatology Outpatient Clinic of the Alexandria Main University Hospital. Sultan Hussein, Azarita Alexandria 21519 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dermatology Department, Faculty of Medicine, University of Alexandria Sultan Hussein, Azarita Alexandria 21519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dermatology Department, Faculty of Medicine, University of Alexandria Sultan Hussein, Azarita Alexandria 21519 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Aisha Abdelmoneim Ismail 245 El Horeya street sporting ,5th floor flat 5 Alexandria 21525 Egypt
Carmen Ibrahim Farid Mohammed Amin El Areesh street,No2,smouha,3rd floor#302 Alexandria 21646 Egypt
Samar Kamal El-Kholy 5 Yatherb group, Acid Compound, Smouha, #13 Alexandria 21641 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aisha Ismail eishaismail777@hotmail.com 002-01009571777 245 El Horeya street sporting ,5th floor flat 5
City Postal code Country Position/Affiliation
Alexandria 21524 Egypt Professor of Dermatology, Venereology and Andrology Faculty of Medicine, University of Alexandria.
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 002-01223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21646 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Carmen Amin carmen271173@yahoo.com 002-01222966670 El Areesh street,No2,smouha,3rd floor#302
City Postal code Country Position/Affiliation
Alexandria 21646 Egypt Lecturer in Dermatology, Venereology and Andrology, Faculty of Medicine, University of Alexandria.
REPORTING
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