Contact information
Type
Scientific
Primary contact
Dr SW Lanigan
ORCID ID
Contact details
Department of Dermatology
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom
+44 (0)121 554 3801
Sean.Lanigan@swbh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0064122126
Study information
Scientific title
A prospective within-patient randomised controlled trial of the treatment of vitiligo with the 308-nm excimer laser: a pilot study
Acronym
Study hypothesis
The main purpose of this study is to determine the efficacy of the 308-nm excimer laser in the treatment of facial vitiligo which is a very cosmetically disabling disorder. This will be a prospective within patient randomised controlled trial and will investigate and quantify the repigmentation achieved with this treatment. We shall also be monitoring the side effects of the treatment if any. The other aspect of the study is to determine if the repigmentation achieved is sustained over a duration of time.
Ethics approval
Not provided at time of registration
Study design
Single centre, patient volunteers, prospective, controlled, therapeutic, observational, single-blind, devices, longitudinal, invasive procedures, randomised study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Skin and Connective Tissue Diseases: Facial vitiligo
Intervention
Not provided at time of registration
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
22/04/2003
Overall trial end date
01/06/2005
Reason abandoned
Eligibility
Participant inclusion criteria
17 to 48 patient volunteers will be recruited.
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
48
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
22/04/2003
Recruitment end date
01/06/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
City Hospital
Birmingham
B18 7QH
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Sandwell and West Birmingham Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
2004 results in conference proceedings: Bhat J, Ladoyanni E, Lanigan SW: A prospective, within patient, randomised controlled trial (RCT) of the treatment of facial vitiligo with the 308-nm excimer laser. J Eur Acad Dermatol Venereol 2004; 18(suppl 2): 148 FC04.2
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary