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.: PACTR201806003302197 Date of Approval: 06/04/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison between vitamin D3, triamcinolone, and fractional CO2 laser for treatment of keloids and hypertrophic scars
Official scientific title Clinical and histopathologic evaluation of intralesional injection of vitamin D3, triamcinolone, and fractional carbon dioxide in treatment of keloids; a prospective randomized controlled trial
Brief summary describing the background and objectives of the trial keloids are skin lesions that occur due to uncontrolled overgrowth of the fibroblasts and negatively impact the quality of life specially if affect sites of cosmetic concern. Multiple treatment modalities are introduced for treatment of keloids but with unsatisfactory results. Vitamin D3 was found to decrease in vitro growth of fibroblasts. Based on these facts, we aimed to study safety and efficacy of intralesional injection of vitamin D3 compared with intralesional injection of triamcinolone and fractional CO2 laser in treatment of keloids 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 Keloids and hyoertrophic scars,Skin and Connective Tissue Diseases
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 10/09/2018
Actual Last follow-up date 10/09/2018
Anticipated target sample size (number of participants) 90
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 Randomised Simple randomisation using by using procedures such as coin-tossing Sealed opaque envelopes Masking/blinding 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
Experimental Group Vitamin D3 4 sessions with 2 weeks interval 2 months intralesional injection 30
Control Group Triamcinolone acetonide injection 4 sessions with 2 weeks interval 2 months intralesional injection 30
Control Group fractional CO2 laser 4 sessions with 2 weeks interval 2 months laser sessions 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age: >18 years both sexes all skin phototypes pregnancy and lactation age < 18 years history of current treatment for keloids history of treatment for keloids within 6 months prior to the study history of hypersensitivity to triamcinolone or vitamin D3 history of systemic retenoids within 6 months prior to study any dermatologic diseases other than keloid hypertrophic and atrophic scars 19 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 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
Rania Abdelghani 3 El Fedaa street Nasrcity Cairo 11371 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rania Abdelghani 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
Public Enquiries Rania Abdelghani 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 Abdelghani 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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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information