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.: PACTR202505517735790 Date of Approval: 20/05/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Efficacy of Intralesional 5-Fluorouracil Versus Cryotherapy in the Treatment of Palmoplantar Warts: A Randomized Clinical Trial
Official scientific title Comparative Efficacy of Intralesional 5-Fluorouracil Versus Cryotherapy in the Treatment of Palmoplantar Warts: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial Background and Rationale Background: Warts are small, benign growths caused by human papilloma virus (HPV) infection of the skin or mucous membrane. 5-Fluorouracil (5-FU) is an antimetabolite drug that stops nucleic acid synthesis. Aim of the study This study aimed to investigate the clinical efficacy of intralesional 5-fluorouracil injection in comparison with cryotherapy to treat common and palmoplantar warts.
Type of trial Observational
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 Treatment: Other
Anticipated trial start date 01/11/2023
Actual trial start date 30/11/2023
Anticipated date of last follow up 30/06/2024
Actual Last follow-up date 30/06/2024
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group 5 fluorouracil Intralesional injection of 5-FU + LE every 2 weeks (max 6 sessions). every 2 weeks for 6 sessions . Intralesional injection of 5-FU admixed with lidocaine and epinephrine every 2 weeks (max 6 sessions). 30 Active-Treatment of Control Group
Experimental Group cryotherapy Cryotherapy using liquid nitrogen with 2 freeze-thaw cycles every 2 weeks. every 2 weeks for a maximum of 6 sessions Cryotherapy using liquid nitrogen with 2 freeze-thaw cycles every 2 weeks. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Immunocompetent adults (>19 years) Asthma, febrile illness, immunosuppression, hypersensitivity Adult: 19 Year-44 Year 19 Year(s) 44 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 08/03/2023 Damietta Faculty of Medicine Ethics committee IRB 00012367
Ethics Committee Address
Street address City Postal code Country
New Damietta- th District Damietta 34517 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare the clinical efficacy of intralesional 5-FU + LE versus cryotherapy. during sessions and for 3 months following the last treatment
Secondary Outcome To assess patient satisfaction, recurrence rates, and adverse effects in both groups. during sessions and for 3 months after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Azhar university Damietta Hospitals Damietta university Damietta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Abeer Zakaria Abou breka University street Damietta 34511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Osama Elshabory Damietta street Damietta Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elsaie egydoc77@yahoo.com +201099501169 Tarablous street
City Postal code Country Position/Affiliation
cairo 11371 Egypt Professor of Dermatology
Role Name Email Phone Street address
Principal Investigator Abeer Aboubreka elshabory@yahoo.com +201033064677 Damietta street
City Postal code Country Position/Affiliation
Damietta Egypt Damietta Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Osama Elshabory elshabory@yahoo.com 201033064667 Damietta street
City Postal code Country Position/Affiliation
Damietta Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data (IPD) that underlie the results reported in the article will be shared, including variables related to: Baseline characteristics (age, sex, wart type, duration, size) Treatment allocation Clinical response scores Number and size of warts before and after treatment Adverse events and recurrence rates Patient satisfaction scores Data will be anonymized to ensure participant confidentiality. Informed Consent Form,Statistical Analysis Plan,Study Protocol IPD will be made available starting 6 months after publication of primary results and will remain available for 5 years. Access will be granted to researchers whose proposed use of the data has been approved by an independent review committee (IRC) or by the principal investigator. Data requestors must: Provide a methodologically sound proposal Sign a data access agreement Agree to use data solely for the intended research purpose Requests should be directed to the corresponding author via institutional email.
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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 16/05/2025 not changed Immunocompetent adults (>18 years) Immunocompetent adults (>19 years)
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 16/05/2025 Self funding however reviewer asked for name of principal investigator as source of funding None, Self funded, Cairo, , Egypt, Self Funded, Abeer Zakaria Abou breka, University street , Damietta , 34511, Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Minimum age 16/05/2025 updated as per request 18 Year(s) 19 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Maximum age 16/05/2025 updated as per request 45 Year(s) 44 Year(s)