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.: PACTR201705002279419 Date of Approval: 08/05/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Comparative Study between the Effects of 308-nm Excimer light and Narrow-Band Ultraviolet B in the Treatment of Vitiligo
Official scientific title A Comparative Study between the Effects of 308-nm Excimer light and Narrow-Band Ultraviolet B in the Treatment of Vitiligo
Brief summary describing the background and objectives of the trial Background: The 308-nm monochromatic Excimer light (MEL) may present some advantages as compared to Narrow Band Ultraviolet B (NB UVB) for the treatment of vitiligo. To the best of our knowledge, no studies compared the histopathological changes of vitiligo lesions before and after treatment by MEL and NB UVB. Aim: To compare the early effects of NB UVB phototherapy and 308-nm MEL in vitiligo patients clinically, histopathologically and immunohistochemically. Patients and Methods: Thirty patients with non-segmental vitiligo will be enrolled in this study. Vitiligo lesions will be treated twice weekly for 6 weeks with 308-nm MEL, while NB-UVB phototherapy will be used to treat lesions contra laterally. Skin biopsies will be taken from lesional areas before and after 6 weeks of phototherapy by either modality for histopathological study with Haematoxylin & Eosin (H&E) or immunohistochemically using Human Melanoma Black-45 (HMB-45) stain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Skin and Connective Tissue Diseases,vitiligo
Sub-Disease(s) or condition(s) being studied
Purpose of the trial compare the early effects of NB UVB phototherapy and 308-nm MEL in vitiligo patients
Anticipated trial start date 01/05/2014
Actual trial start date 02/06/2014
Anticipated date of last follow up 01/11/2014
Actual Last follow-up date 02/12/2014
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomisation using a randomisation table from a statistics book Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group phototherapy twice weekly 6 weeks NBUVB 30
Experimental Group phototherapy twice weekly 6 weeks MEL 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Patient¿s age more than 18 years ¿ Patients suffering from non-segmental Vitiligo (confirmed using Wood¿s light) ¿ Patients with localized, segmental, genital or axillary vitiligo. ¿ Patients with light sensitive or aggravated dermatoses. ¿ Patients with or giving a past history of melanoma or any NMSC. ¿ Patients with aphakia or cataract. ¿ Patients with abnormal liver or renal functions. ¿ Pregnant or lactating female patients. ¿ Patients who received treatment for vitiligo within the last 6 months. 18 Year(s) 70 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 06/06/2012 nrc ethical committee
Ethics Committee Address
Street address City Postal code Country
33 bohoth st. cairo 11211 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome effect of NBUVB on vitiligo before treatment after treatment ( 6 weeks) or 12 sessions
Secondary Outcome side effects within and after treatment
Primary Outcome effect of MEL on vitiligo before treatment and after 6 weeks of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national research centre 33 bohoth street. cairo 11211 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national research centre 33 bohoth street. cairo 11211 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NILES inside cairo university cairo 11311 Egypt University
COLLABORATORS
Name Street address City Postal code Country
noha sami hanafy 41 moez eldawla cairo 11411 Egypt
dalia gamal aly 55 moez eldawla cairo 11511 Egypt
manal salah giza giza 11611 Egypt
nevein ahmed sami mokkattam cairo 11711 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Noha Hanafy nohasamihanafy@gmail.com 01002009390 41 moez eldawla
City Postal code Country Position/Affiliation
cairo 11765 Egypt assistant researcher
Role Name Email Phone Street address
Public Enquiries manal salah m.salah.2000@hotmail.com 01001873225 manyal st.
City Postal code Country Position/Affiliation
cairo 11223 Egypt professor of dermatology
Role Name Email Phone Street address
Scientific Enquiries Dalia Aly dalia.g.aly@gmail.com 01223720243 55 moez eldawla
City Postal code Country Position/Affiliation
cairo 11765 Egypt Professor researcher
Role Name Email Phone Street address
Scientific Enquiries Nevien Sami nevien_a_sami@hotmail.com 01005755739 mokkattam
City Postal code Country Position/Affiliation
cairo 11765 Egypt professor
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information