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.: PACTR201801002989151 Date of Approval: 19/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title combined fractional co2 laser and Nd:YAG laser in hidradenitis suppurativa
Official scientific title Combined fractional CO2 laser and long pulsed Nd:YAG (1064 nm) laser in treatment of hidradenitis suppurativa; a prospective randomized intraindividual controlled study
Brief summary describing the background and objectives of the trial Hidradenitis suppurativa is a chronic, recurrent, and disabling disease that negatively impacts the quality of life of the patients. Multiple treatment modalities are used but with variable response and recurrence rate. Different types of lasers have been used for treatment of hidradenitis suppurativa. We investigated the safety and efficacy of Combined fractional CO2 laser and long pulsed Nd:YAG (1064 nm) laser in treatment of hidradenitis suppurativa with clinical and histopathologic evaluation
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied hidradenitis suppurativa,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 02/01/2017
Actual trial start date 09/01/2017
Anticipated date of last follow up 31/10/2017
Actual Last follow-up date 20/12/2017
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
nil known Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt
nil known Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt
nil known Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt
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 CO2 laser and long pulsed Nd:YAG (1064 nm) laser twice/month 2 months laser sessions 20
Control Group Long pulsed Nd:YAG (1064 nm) laser twice/month 2 months laser sessions 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age: > 18 years both sexes Hurley`s stage I and II bilateral and symmetric lesions one or more anatomic sites Age < 18 years Hurley`s stage III Pregnancy and lactation history of treatment within 2 weeks prior to the study systemic diseases 20 Year(s) 35 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 29/12/2016 the research 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 physician global assessment baseline 2 weeks after the last session
Primary Outcome patients` satisfaction 2 weeks after the last session
Primary Outcome histopathology baseline 2 weeks after the last session
Secondary Outcome recurrence 3 months after the last session
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al-Zahraa University Hospital Al-Azhar University Hospital street Cairo 11517 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
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 Al Fedaa street Cairo 11371 Egypt
Amira Abdel Azim Ard elgolf Cairo 11371 Egypt
Rania Tharwat Kafr Sakr Sharqyia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amira Abdel Azim amiraabdelazim@hotmail.com 002 01223945923 3 El Fedaa street Nasrcity
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 Abdelghani rania_abdulghani@hotmail.com 002 01283433887 3 El Fedaa street Nasrcity
City Postal code Country Position/Affiliation
Cairo 11371 Egypt Faculty of Medicine for Girls, Al-Azhar University, Armed Forces College of Medicine
Role Name Email Phone Street address
Scientific Enquiries Rania Abdelghani rania_abdulghani@hotmail.com 002 01283433887 3 El Fedaa street Nasrcity
City Postal code Country Position/Affiliation
Cairo 11371 Egypt Faculty of Medicine for Girls, Al-Azhar University, Armed Forces College of Medicine
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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