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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201810545064445 Date of Registration: 15/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assessment of S100B and CXCL9 as markers of ‎activity in non-segmental vitiligo.‎
Official scientific title Assessment of S100B and CXCL9 as markers of ‎activity in non-segmental vitiligo.‎
Brief summary describing the background and objectives of the trial Vitiligo is frequent disease affecting 1-2% of the population characterized by milky white depigmented ‎patches that can affect any area of the body causing significant stress and psychological burden to the ‎patients. The clinical course of ‎vitiligo is unpredictable including periods of disease stability and disease flares. This nature of the disease ‎makes its management challenging Vitiligo is a progressive disease and during the course of the disease the ‎patients suffer from the activity phases characterized by the appearance of new lesions, enlargement of the ‎old lesions and koebnerization which means appearance of new lesions at the sites of trauma. Different ‎theories have been proposed to explain the pathogenesis of vitiligo including the autoimmune pathogenesis, ‎increased oxidative stress, deficient adhesion proteins and others. On clinical basis, hypopigmented skin ‎areas with blurred borders and confetti-like depigmentation have been associated with disease activity. ‎However, these signs are often subjective and only present in a minority of the patients, therefore, ‎biomarker analysis could be useful to follow patients over time and even predict the chance of future ‎disease progression. S100B is a damage associated molecular protein that was first found to be elevated in ‎neurological disease and melanoma. It was hypothized that melanocyte cell death in vitiligo can be ‎associated with high levels of S100B and even higher levels in active rather than stable vitiligo. CXCL9 one ‎of the CXC chemokine family was also found to be elevated in active vitiligo more than stable disease. ‎Targeting such biomarkers may help controlling vitiligo activity. Through our work, we aim to understand ‎more about the etiology and pathogenesis of vitiligo allowing tailored targeted treatment of this disease.‎ ‎
Type of trial CCT
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 Diagnosis / Prognosis
Anticipated trial start date 07/10/2018
Actual trial start date 15/10/2018
Anticipated date of last follow up 07/06/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status 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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group oral dexamethasone minipulse steroid will be given and skin and blood samples will be collected 2.5 mg for two successive days per week 3-6 months oral minipulse steroid " dexamethasone" therapy will be given to patients with active non-segmental vitiligo for 3-6 months for the purpose of achievement of vitiligo stability. skin and blood samples will be collected at the beginning of the study and will be repeated after maximum of 6 months 20
Control Group skin and blood sample will be collected skin and blood sample will be collected only once at the beginning of the study skin and blood sample will be collected only once at the beginning of the study twenty healthy participants along with twenty patients with stable non-segmental vitiligo will be subjected to a skin biopsy and blood sampling at the beginning of the study after disinfection and adminstration of topical anesthesia 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
‎-‎ Patients with non-segmental vitiligo.‎ ‎-‎ Age above 18 years.‎ ‎-‎ Patients with segmental vitiligo.‎ ‎-‎ Patients who received treatment in the past 3 months. ‎ ‎-‎ Patients with absolute contraindications for systemic steroid therapy.‎ ‎-‎ Patients with active neurological disease.‎ Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 31/03/2018 research ethics committee faculty of medicine cairo university
Ethics Committee Address
Street address City Postal code Country
kasr al aini manial cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Verifying the relation between S100B, CXCL9 and vitiligo activity in patients with ‎non-segmental vitiligo and their possible use as diagnostic and prognostic markers ‎of disease activity.‎ 6 months
Secondary Outcome • Detection the effect of steroid minipulse therapy on S100B and CXCL9 ‎levels in active non-segmental vitiligo.‎ • Detection of a possible relation between the change in S100B and CXCL9 ‎levels and subsidence of vitiligo activity.‎ 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
cairo university faculty of medicine dermatology department kasr al aini manial cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
kholoud helmy agouza giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university kasr al aini manial cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
marwa amer helwan cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator doaa mahgoub doaamahgoubb@hotmail.com02 0201005670009 maadi
City Postal code Country Position/Affiliation
cairo Egypt professor of dermatology in faculty of medicine cairo university
Role Name Email Phone Street address
Scientific Enquiries marwa amer m_amer_84@yahoo.com 02012222208725 helwan
City Postal code Country Position/Affiliation
cairo Egypt lecturer of dermatology faculty of medicine cairo university
Role Name Email Phone Street address
Public Enquiries kholoud helmy kholoudhelmy88@ggmail.com 0201223488773 agouza
City Postal code Country Position/Affiliation
giza Egypt assisstant lecturer of dermatology faculty of medicine cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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