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.: PACTR202006534973105 Date of Registration: 17/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Measurement of serum soluble CD4 levels in patients with external anogenital warts before and after intralesional injection of tuberculin purified protein derivative
Official scientific title Measurement of serum soluble CD4 levels in patients with external anogenital warts before and after intralesional injection of tuberculin purified protein derivative
Brief summary describing the background and objectives of the trial Anogenital warts are growths caused by human papilloma virus infection which causes significant psychosocial morbidity. Intralesional immunotherapy is a promising treatment that is able to stimulate a delayed-type hypersensitivity reaction to different antigens as well as wart tissue. This treatment is suggested to increase T helper 1 lymphocytes activity to destroy HPV. Aim of this study was to measure the level of serum sCD4 in patients with anogenital warts before and after intralesional tuberculin purified protein derivative injection.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/09/2018
Actual trial start date 01/10/2018
Anticipated date of last follow up 01/09/2019
Actual Last follow-up date 03/11/2019
Anticipated target sample size (number of participants) 49
Actual target sample size (number of participants)
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Patients with anogenital warts afmeasurment of sCD4 level after PPD injection 10 tuberculin 3 months or 6 sessions measurement of serum sCD4 level after PPD injection in warts 49
Control Group PPD injection 10 tuberculin units of PPD 3 months 6 sessions patients before injection considered control group 49 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
male patients complaining of external anogenital warts more than 18 years of age. Exclusion Criteria included immuno-compromised patients (HIV, chronic debilitating diseases or malignancy); patients with hemolytic blood diseases patients, patients with active tuberculosis and patient received any other modality for treatment for genital warts during study or in the last 3 months. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Male
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 09/09/2018 Suez Canal University faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Ring road Ismailia 41511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean level of serum soluble CD4 was significantly higher after than before PPD injection. end of study 6 sessions
Secondary Outcome Serum sCD4 levels were significantly correlated to clinical response rates as the higher the level of serum sCD4 the more wart recovery. end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University. Ring road Ismailia 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed Azab Ring Road Ismailia 41511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Azab dr.mohamed_azab@yahoo.com 002001224560152 Ring Road km 4.5
City Postal code Country Position/Affiliation
ismailia 41511 Egypt lectrurer
Role Name Email Phone Street address
Public Enquiries Mohamed Azab Dr.Mohamed_azab@yahoo.com 002001224560152 km4.5 Rin g road
City Postal code Country Position/Affiliation
ismailia 41511 Egypt lectrurer
Role Name Email Phone Street address
Scientific Enquiries Mohamed Azab dr.Mohamed_azab@yahoo.com 00201224560152 4.5 km ring road
City Postal code Country Position/Affiliation
ismailia 41511 Egypt lectrurer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Genital warts are common distressing problem in our community, patients attending Dermatology and Andrology clinics with complaints of anogenital warts were our target. Patients were informed about the aims, objectives and planned design and conduct of the study. Patients also shared with us the way, place and time of implementations of the study. Partners of the participants in the study were also counseled as possible with patients to be aware of the benefit of the research and encourage their partners to continue the study. Encouragement of patients to complete study was done by informing the patients the severity of anogenital warts on their health and on their partners and risk of malignant transformation as well as ease and simplicity of the procedure and great value in preventing recurrence. Outcome measures and photographic assessment of clinical wart recovery and measurement of serum sCD4 were discussed with the patients and were approved by them. Patients agreed on plans of dissemination of the study results to participants and linked communities. Informed Consent Form,Study Protocol 1 year controlled access
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