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.: PACTR201803003151322 Date of Approval: 27/02/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Autoinoculation versus intralesional injection of bleomycin in the treatment of multiple recalcitrant warts
Official scientific title Autoinoculation versus intralesional injection of bleomycin in the treatment of multiple recalcitrant warts
Brief summary describing the background and objectives of the trial Background: Multiple recalcitrant warts are warts with number of more than five in an individual patient and are resistant to more than one therapeutic option.They have a significant morbidity by inducing discomfort both physically and psychologically.Multiple recalcitrant warts treatment may fail to clear the warts even after repeated sessions of various physical therapeutic remedies as electrocautery,cryotherapy,laser , or radiofrequency.In this study,we compared the efficacy and safety of autoincuolation versus intralesional injection of bleomycin in treatment of multiple recalcitrant warts. Aim of the work: The aim of the study is to compare the efficacy and safety of autoincuolation versus intralesional injection of bleomycin in warts treatment. Patients and Methods:This Intervention study (pre - post intervention)involved 50 patients with multiple recalcitrant warts , 25 for intralesional bleomycin injection and 25 for autoinoculation.The two patients groups were randomizdely selected from the outpatient clinic of dermatology , venereology and andrology department,Zagazig university hospitals.Group (A) received treatment with the autoinoculation procedure, and group (B) treated with intralesional bleomycin injection.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Human papilloma virus causing warts,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/02/2017
Actual trial start date 11/02/2017
Anticipated date of last follow up 01/02/2018
Actual Last follow-up date 15/02/2018
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
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 randomisation using a randomisation table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Autoinoculation group 3 sessions monthly for every patient. 3 months for every one One session every month for every patient 25
Control Group Intralesional injection of bleomycin 3 sessions for each patient every month 3months for every patient with one session per month Intralesional injection of bleomycin in one or more of the multiple recalcitrant warts 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- patients with multiple recalcitrant warts. -patients with age ranged from 18 ¿ 45 years. -Both sexes were involved in this study. -The individual patient may have multiple types of warts at different sites i.e.one patient may have palmoplantar warts and genital warts and we treated both types in two different sites in the same patient. -patients having other dermatological diseases. -pregnant and lactating females,children. -immunosuppressed individuals. -patient with koebner phenomenon. -patient with HCV or HIV. -patient on aspirin or anticoagulant therapy. -patient with bleeding tendency. -patient with lung diseases( in bleomycin treated group). -patients with mucosal warts. 18 Year(s) 45 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 14/02/2017 IRB faculty of medicine Zagazig university
Ethics Committee Address
Street address City Postal code Country
faculty of medicine Zagazig university Egypt Zagazig 44511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome is to compare the efficacy and safety of autoincuolation versus intralesional injection of bleomycin in warts treatment. after completing the treatment sessions(3 sessions ,one monthly for 3 months of every patient) of all patients in both groups.measured by comparing the clinical response (either good, minimal ,or no response)on manipulated warts.
Secondary Outcome to detect the remote clinical response remote nonmanipulated warts after completing the treatment sessions(3 sessions ,one monthly for 3 months of every patient) of all patients in both groups.measured by detecting the clinical response (either +ve remote response or -ve remote response) of remote nonmanipulated warts
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine Zagazig university department of dermatology faculty of medicine Zagazig university department of dermatology Zagazig 44511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine Zagazig university faculty of medicine zagazig university Zagazig 44511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Zagazig university faculty of medicine zagazig university Zagazig 44511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Ibrahim ElGhareeb ElGanainy faculty of medicine zagazig university Zagazig 44511 Egypt
Mohamed Khater faculty of medicine zagazig university Zagazig 44511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Ibrahim ElGhareeb ElGanainy moh_elghareeb@yahoo.com 00201092907455 faculty of medicine zagazig university department of dermatology
City Postal code Country Position/Affiliation
zagazig 44511 Egypt lecturer of dermatology
Role Name Email Phone Street address
Public Enquiries Mohamed Ibrahim ElGhareeb ElGanainy moh_elghareeb@yahoo.com 00201092907455 faculty of medicine zagazig university department of dermatology
City Postal code Country Position/Affiliation
zagazig 44511 Egypt lecturer of dermatology
Role Name Email Phone Street address
Scientific Enquiries Mohamed Ibrahim ElGhareeb ElGanainy moh_elghareeb@yahoo.com 00201092907455 faculty of medicine zagazig university department of dermatology
City Postal code Country Position/Affiliation
zagazig 44511 Egypt lecturer of dermatology
REPORTING
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