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.: PACTR201806003307977 Date of Approval: 06/04/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title impact of metabolic syndrome on response to intradermal injection of dutastride in patients with female pattern hair loss
Official scientific title Impact of metabolic syndrome on response to intradermal injection of dutastride 0.02% in patients with female pattern hair loss; a prospective randomized controlled trial
Brief summary describing the background and objectives of the trial Metabolic syndrome adds to the severity of some dermatologic diseases e.g., psoriasis and female pattern hair loss. Additionally, it may also impact the treatment response of these conditions. based on these facts, we aime to study theImpact of metabolic syndrome on response to intradermal injection of dutastride 0.02% in patients with female pattern hair loss as a prospective randomized controlled trial.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied female pattern hair loss,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 09/04/2018
Actual trial start date 09/04/2018
Anticipated date of last follow up 15/10/2018
Actual Last follow-up date 15/10/2018
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
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 by using procedures such as coin-tossing 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 0.02% dutastride 8 sessions 12 weeks intradermal injection 45
Experimental Group 0.02% dutastride/ metabolic syndrome 8 sessions 12 weeks intradermal injection 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
grade I and II of female pattern hair loss age 18-50 years male patients age <18 years and > 50 years grade III and IV of female pattern hair loss patients with history of hypersensitivity to dutastride other types of alopecia pregnancy and lactation 18 Year(s) 50 Year(s) Female
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 29/03/2018 Research and ethics committee of Al-Azhar University Hospitals
Ethics Committee Address
Street address City Postal code Country
Al Nasr street Cairo 11751 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome degree of improvement 2 weeks and 3 months after the last session
Primary Outcome patient`s satisfaction 2 weeks and 3 months after the last session
Secondary Outcome Persistence of the response, improvement, or worsening 3 months after the last session
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al-Zahraa University Hospital Al-Zahraa University Hospital street Cairo 11535 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No fund
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Al-Zahraa University Hospital Al-Zahraa University Hospital street Cairo 11535 Egypt Hospital
Primary Sponsor Faculty of Medicine for Girls, Al-Azhar University Al Nasr street Cairo 11751 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nayera Moftah 3 El Fedaa street Nasrcity Cairo Egypt
Rana Mubarak 3 El Fedaa street Nasrcity Cairo Egypt
Rania Abdelghani 3 El Fedaa street Nasrcity Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nayera Moftah nayeramoftah@hotmail.com +2-01222117774 Ard ElGolf, Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Faculty of Medicine for Girls, Al-Azhar University
Role Name Email Phone Street address
Public Enquiries Rania Madi rania_abdulghani@hotmail.com +2-01283433887 3 El Fedaa street Nasrcity
City Postal code Country Position/Affiliation
Cairo 11371 Egypt Faculty of Medicine for Girls, Al-Azhar University
Role Name Email Phone Street address
Scientific Enquiries Rania Madi rania_abdulghani@hotmail.com +2-01283433887 3 El Fedaa street Nasrcity
City Postal code Country Position/Affiliation
Cairo 11371 Egypt Faculty of Medicine for Girls, Al-Azhar University
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information