A prospective within-patient randomised controlled trial of the treatment of vitiligo with the 308-nm excimer laser: a pilot study

ISRCTN	ISRCTN51633881
DOI	https://doi.org/10.1186/ISRCTN51633881
Secondary identifying numbers	N0064122126

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 14/05/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr SW Lanigan
Scientific

Department of Dermatology
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom

Phone	+44 (0)121 554 3801
Email	Sean.Lanigan@swbh.nhs.uk

Study information

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
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A prospective within-patient randomised controlled trial of the treatment of vitiligo with the 308-nm excimer laser: a pilot study
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Skin and Connective Tissue Diseases: Facial vitiligo
Intervention	Not provided at time of registration
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	22/04/2003
Completion date	01/06/2005

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Not Specified
Target number of participants	48
Key inclusion criteria	17 to 48 patient volunteers will be recruited.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	22/04/2003
Date of final enrolment	01/06/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

City Hospital

Birmingham
B18 7QH
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Sandwell and West Birmingham Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
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
IPD sharing plan

Editorial Notes

14/05/2018: Conference proceedings added.
10/05/2018: No publications found, verifying study status with principal investigator
01/03/2016: No publications found, verifying study status with principal investigator