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.: PACTR201811835577312 Date of Approval: 30/11/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Site-oriented depigmentation in vitiligo patients using Q-switched Nd:YAG laser (1064/532nm), cryotherapy and chemical peels: A comparative study.
Official scientific title Site-oriented depigmentation in vitiligo patients using Q-switched Nd:YAG laser (1064/532nm), cryotherapy and chemical peels: A comparative study.
Brief summary describing the background and objectives of the trial The face and neck were chosen to verify the possibility of introducing TCA peels, 25 and 50%, as depigmenting agents and compare their efficacy with QS Nd:YAG laser (532 and 1064 nm) in depigmentation for vitiligo cases with undesired residual pigmented. The upper limb was chosen to evaluate and compare the effectiveness of phenol peel 88%, cryotherapy and QS Nd:YAG (532 and 1064 nm) laser in depigmentation of remaining normal-colored.
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
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/02/2016
Actual trial start date 25/06/2017
Anticipated date of last follow up 14/11/2016
Actual Last follow-up date 25/03/2018
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Chemical peels and laser TCA PEELS: every 2 weeks Qs NdYAG laser: every month 3 months o TCA peel 25%: One to three passes till frosting. o TCA peel 50%: One pass. o Frequency-doubled QS Nd:YAG laser (1064 nm) followed by the frequency doubled KTP laser (532nm) . 20
Experimental Group Cryotherapy chemical peel and laser monthly sessions 3 months o Phenol peel 88%: One pass was applied to a localized spot.. o Cryotherapy: Cotton-tipped swabs were used to apply liquid nitrogen (−196°C). o Frequency-doubled QS Nd:YAG laser:similar parameters to group 1. 20
Control Group no intervention 3 months untreated patients' skin was the control for each patient and was not subjected to any intervention. 40 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients older than 12 years having either vitiligo universalis that left behind residual normally pigmented and cosmetically unacceptable areas over face, neck and/or upper limbs, or vitiligo vulgaris recalcitrant to treatment and interfering with patients’ social acceptance were included.  Active cutaneous infection or inflammatory dermatoses.  Uncooperative patients.  Unrealistic expectations.  History of abnormal scarring.  Patients having cardiac or renal problems.  Patients with impaired sensation or circulation, or abnormal reactions to cold (Raynaud's phenomenon and cold urticaria). Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 13 Year(s) 65 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 16/04/2015 dermatology research ethics committee
Ethics Committee Address
Street address City Postal code Country
Al Manial Cairo 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The used depigmenting modalities proved to be effective in depigmentation of the remaining pigmented areas in vitiligo cases 3 months after start
Secondary Outcome TCA peels are tolerable, cheap and available depigmenting agents in face and/ or neck depigmentation. QsNdYAG, cyotherapy and phenol 88 gave comparable results in upper limb depigmentation. 3 months after satrt
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dermatology outpatient clinic Al Manial Cairo 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sarah Ibrahim Ismail Neigbourhood 9, Bldg 4, 3rd Floor, Flat 6. 15 May City 14531 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sarah Ibrahim Neigbourhood 9, Bldg 4, 3rd Floor, Flat 6, 15 May City, Cairo, Egypt. 15 May City 14531 Egypt individuals
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Medhat El Mofty medhatelmofty@hotmail.com +201001406742 Zamalek
City Postal code Country Position/Affiliation
Cairo 11568 Egypt Professor of Dermatology Cairo University
Role Name Email Phone Street address
Public Enquiries Sarah Ismail sarah.ibrahim@kasralainy.edu.eg +201224247232 15 May
City Postal code Country Position/Affiliation
Cairo 14531 Egypt Lecturer of Dermatology Cairo University.
Role Name Email Phone Street address
Scientific Enquiries Sarah Ismail sarah.ibrahim@kasralainy.edu.eg +201224247232 15 May
City Postal code Country Position/Affiliation
Cairo 14531 Egypt Lecturer of Dermatology Cairo University.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information