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.: PACTR202003484099670 Date of Approval: 11/03/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Serum Level of 8-Isoprostane In Oral Erosive Lichen Planus Before and After Treatment With Lycopene: RCT
Official scientific title Serum Level of 8-Isoprostane in Patients with Oral Erosive Lichen Planus Before and After Treatment with Lycopene: A Randomized Controlled Clinical Trial
Brief summary describing the background and objectives of the trial Lichen planus is a chronic mucocutaneous disorder with immune-mediated pathogenesis. Its pathogenesis is explained as a cell-mediated autocytotoxicity. Studies have also reported that oxidative stress plays a role in lichen planus through the production of reactive oxygen species that acts as a trigger in that immune response. Reactive oxygen species induce lipid peroxidation that appears to be a major manifestation of oxidative stress. 8-isoprostane is considered a reliable biomarker and product of lipid peroxidation. Lycopene is a fat-soluble carotenoid that has various benefits on human health. It is an antioxidant that scavenges free radicals as singlet oxygen and is said to have a role in the treatment of some oral diseases specifically lichen planus. The aim of the study is to measure the serum level of 8-isoprostane in oral erosive lichen planus patients before and after treatment with lycopene in comparison to treatment with corticosteroids. Furthermore, to evaluate and compare the effect of both treatment modalities clinically.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2019
Actual trial start date
Anticipated date of last follow up 01/04/2020
Actual Last follow-up date 15/04/2020
Anticipated target sample size (number of participants) 20
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lycopene 10 mg daily 8 weeks Softgel capsules will be administered orally as a daily morning dose. 10
Control Group Corticosteroids 40 mg orally 8 weeks 40 mg tablets will be administered orally as a daily morning dose for 4 consecutive weeks , then the dose will be tapered gradually for the next 4 weeks. 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients who are unresponsive to the conventional topical corticosteroid therapy and in need of systemic oral corticosteroids. Smoking and tobacco use in any form. Pregnant and lactating females. suspected restoration or drug-related reaction (Lichenoid Contact/Drug reaction). any systemic disease ( Diabetes, liver disease, renal disease, any other autoimmune or collagen disease). cutaneous Lichen Planus (Skin lesions associated with oral lesions). Lesions showing any dysplastic changes in the biopsy specimen. Patients receiving any kind of systemic or local treatment for LP for the past one month. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 60 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 16/09/2018 Institutional Review Boards IRB at the faculty of dentistry Alexandria University IRB NO 00010556 IORG 0008839
Ethics Committee Address
Street address City Postal code Country
Champollion St., Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual Analogue Scale (VAS) Baseline, week 4, week 8, week 20
Primary Outcome serum 8-isoprostane levels Baseline, week 8
Secondary Outcome Clinical score Baseline, week 4, week 8, week 20
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient Clinic of the Oral Medicine Periodontology Diagnosis and Radiology Department Faculty of Dentistry Alexandria University Champollion st, El Azareta Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Aliaa Abdelmoniem Bedeir 29, Fawzy Moaz street, Smouha Alexandria 21615 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oral Medicine Periodontology Diagnosis and Radiology Department Faculty of Dentistry Alexandria University Champollion st, El Azareta Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Aliaa Abdelmoniem Bedeir 29, Fawzy Moaz street, Smouha Alexandria 21615 Egypt
Azza Mohamed Zaki 17 Amir Al behar Mahmoud Hamza street , Sidi Gaber Alexandria 21529 Egypt
Sabah Abdelhady Mahmoud 11 Hassan Amin street, Alsaraya Alexandria 21613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Azza Zaki drazzazaky@yahoo.com 00201222382909 17 Amir Al behar Mahmoud Hamza street , Sidi Gaber
City Postal code Country Position/Affiliation
Alexandria 21529 Egypt Professor of Oral Medicine Periodontology Diagnosis and Radiology Faculty of Dentistry Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Sabah Mahmoud sabahamm@gmail.com 00201069032732 11 Hassan Amin street, Alsaraya
City Postal code Country Position/Affiliation
Alexandria 21613 Egypt Professor of Medical Biochemistry Faculty of Medicine Alexandria University
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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