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.: PACTR201806003306192 Date of Approval: 06/04/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title combined Nd:YAG laser and PRP injection for treatment of periorbital wrinkles
Official scientific title Clinical and dermoscopic evaluation of combined long-pulsed neodymium:yttrium-aluminium-garnet (1064 nm) laser and intradermal injection of autologous platelet rich plasma in treatment of periorbital wrinkles; a prospective randomized controlled trial
Brief summary describing the background and objectives of the trial Periorbital wrinkles have an important role in expression of skin aging and seriously impact quality of life. Multiple surgical and medical treatments are introduced to correct periorbital wrinkles but with unsatisfactory results and considerable side effects. Based on these facts, we aimed to study the safety and efficacy of combined long-pulsed neodymium:yttrium-aluminium-garnet (1064 nm) laser and intradermal injection of autologous platelet rich plasma in treatment of periorbital wrinkles in 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 periorbital wrinkles,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 01/10/2018
Actual Last follow-up date 01/10/2018
Anticipated target sample size (number of participants) 105
Actual target sample size (number of participants) 105
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
Experimental Group combined PRP injection and long pulsed Nd:YAG (1064 nm) laser 3 sessions with 3 weeks interval 8 weeks intradermal injection and laser sessions 35
Control Group intradermal injection of PRP 3 sessions with 3 weeks interval 6 weeks intradermal injection 35
Control Group Long pulsed Nd:YAG (1064 nm) laser 3 sessions with 3 weeks interval 6 weeks laser sessions 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age: 35-60 years female patients modified Fitzpatrick`s scale II and more all skin phototypes age<35 years and >60 years male patients modified Fitzpatrick`s scale I smoking blepharocalesis systemic diseases patients who receive oral anticoagulants patients who receive systemic retinoids within 6 months prior to the study patients with history of cosmetic intervention for correction of the periorbital wrinkles any dermatologic disorders other than periorbital wrinkles 35 Year(s) 60 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
Ghada Abdel Badea` Abdel Aziz Mearag city, Maadi Cairo Egypt
Ahmed Sadek Nozha street Cairo Egypt
Azza Samy Kafr el sheikh Kafr el sheikh Egypt
Rania Abdelghani 3 El Fedaa street Nasrcity Cairo 11371 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ghada Abdel Aziz drghadaomar@yahoo.com +2-01001844489 Al Zahraa University street
City Postal code Country Position/Affiliation
Cairo 11535 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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