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.: PACTR201804003289316 Date of Approval: 03/04/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Topical methotrexate-loaded nanoparticles for the treatment of vitiligo:a clinical trial
Official scientific title Topical methotrexate-loaded nanoparticles for the treatment of vitiligo:a clinical trial
Brief summary describing the background and objectives of the trial Recently,Garza-Mayers and Kroshinsky ,2017 reported a successful trial of methotrexate ,in an up-titrating dose of 12.5-25 mg/week in the treatment of vitiligo.Improvement was noted as early as 6 weeks (for rapidly progressive generalized vitiligo) to 14 months after failure of topical calcineurin inhibitor and phototherapy with no reported serious side effects. Several immune disorders may occur in the skin, such as psoriasis, atopic dermatitis and vitiligo. As the largest organ in the human body, skin provides a unique and non-invasive platform to deliver active pharmaceutical ingredients into superficial lesions or even circulations. In recent years, novel pharmaceutical particles were applied in the topical treatment for skin-related immune disorders to keep the stability, improve the bioactivity, as well as reduce the toxicity of active pharmaceutical ingredient(APIs), or even provide a targeting property for the agents. As the pathogenesis of these diseases is increasingly highlighted, the target site and function of topical delivery of particles become more clear and specific. Therefore, diversified surface engineering of vehicles has gradually gained more attention. Appropriate size, charge and surface modification of API-loaded particles can bring out a favorable effect for skin disorders. In this review, comparison of normal and pathological skin structure, penetration route of various drug particles, nano- and micro- particles applied for skin-related immune disorders are summarized(Sun et al,2015). Aim of the work: -To evaluate the safety and efficacy of methotrexate loaded nano biopolymer as atopical treatment for vitiligo. -To assess the possibility of methotrexate loaded nano biopolymer to be an alternative for conventional vitiligo treatments.
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,vitiligo
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/04/2018
Actual trial start date 11/04/2018
Anticipated date of last follow up 11/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 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 methotrexate treated group once day after day for 6 weeks 6 weeks they will apply a topical gel of methotrexate loaded nano biopolymer on a vitiliginous patch day after day in order to reach an equivalent dose of 12.5 mg/week for 6 weeks.Folic acid supplements will be given to all patients on the methotrexate off days. 30
Experimental Group placebo treated patients once day after day for 6 weeks 6 weeks they will receive a topical placebo for control. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Vitiligo patients who don't use any systemic or local medication for at least one month prior to the onset of the study. -Age more than 18 years -both males and females -Patients have systemic diseases(e.g. pulmonary diseases, hepatic diseases, neutropenia,anemia,pancytopenia) -Patients have a history or an active infection with Hepatitis C. -Pregnant and lactating females -Patients with age less than 18 -Patients suffering from any dermatological disease other than vitiligo. 18 Year(s) 70 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 27/03/2018 alazhar university ,faculty of medicine for girls
Ethics Committee Address
Street address City Postal code Country
alazhar university ,faculty of medicine for girls cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome -To evaluate the safety and efficacy of methotrexate loaded nano biopolymer as atopical treatment for vitiligo. at the end of the study
Secondary Outcome To assess the possibility of methotrexate loaded nano biopolymer to be an alternative for conventional vitiligo treatments. at the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
alazhar university ,faculty of medicine for girls alazhar university ,faculty of medicine for girls cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
alazhar university ,faculty of medicine for girls alazhar university ,faculty of medicine for girls cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor alazhar university ,faculty of medicine for girls alazhar university ,faculty of medicine for girls cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Rana Mohamed Tarek Mohamed Fathy Gheith alazhar university ,faculty of medicine for girls cairo Egypt
Wafaa afifi alazhar university ,faculty of medicine for girls cairo Egypt
Sara Ahmed Galal alazhar university ,faculty of medicine for girls cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rana Mohamed Tarek Mohamed Fathy Gheith ranagheith@hotmail.com 00201005070206 alazhar university,faculty of medicine for girls
City Postal code Country Position/Affiliation
cairo Egypt dermatologist
Role Name Email Phone Street address
Public Enquiries Rana Mohamed Tarek Mohamed Fathy Gheith ranagheith@hotmail.com 00201005070206 alazhar university,faculty of medicine for girls
City Postal code Country Position/Affiliation
cairo Egypt dermatologist
Role Name Email Phone Street address
Scientific Enquiries Rana Mohamed Tarek Mohamed Fathy Gheith ranagheith@hotmail.com 00201005070206 alazhar university,faculty of medicine for girls
City Postal code Country Position/Affiliation
cairo Egypt dermatologist
REPORTING
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