Effect of penetration enhancers in topical photodynamic therapy

ISRCTN	ISRCTN92678315
DOI	https://doi.org/10.1186/ISRCTN92678315
Secondary identifying numbers	N0112112993

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

Dr Ian Pearson
Scientific

Epsom and St Helier NHS Trust
Department of Dermatology
St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom

Phone	+44 (0)20 8296 2000

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Comparison of 20% Aminolaevulinic acid (ALA) versus 20% ALA 2% dimethyl sulphoxide (DMSO) 2% ethylene diamine tetraacetic acid (EDTA) in topical photodynamic therapy
Study objectives	Do penetration enhancers increase the efficacy of photodynamic therapy (PDT)?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Skin and Connective Tissue Diseases: Topical photodynamic therapy (PDT)
Intervention	Two treatment arms in the study, randomised in double blind fashion to receive either topical 20% ALA or 20% ALA, 2% EDTA cream. Both groups will then receive light treatment to the areas to which the cream has been applied. Comparison of the two groups will be by change in size of skin lesion by any tolerance of procedure.
Intervention type	Other
Primary outcome measure	Response of skin lesion clinically by size change at 3 month follow ups.
Secondary outcome measures	Not provided at time of registration
Overall study start date	08/04/2002
Completion date	08/04/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Patients referred for PDT as judged appropriate by dermatologists in local area 2. Patients will have basal cell carcinomas, Bowen's disease or actinic keratoses and will be randomised depending on diagnosis
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	08/04/2002
Date of final enrolment	08/04/2003

Epsom and St Helier NHS Trust

Carshalton
SM5 1AA
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Government

Epsom and St Helier University Hospitals NHS Trust (UK)

No information available

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
IPD sharing plan