Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0112112993
Study information
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
Acronym
Study hypothesis
Do penetration enhancers increase the efficacy of photodynamic therapy (PDT)?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
08/04/2002
Overall trial end date
08/04/2003
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
08/04/2002
Recruitment end date
08/04/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Epsom and St Helier NHS Trust
Carshalton
SM5 1AA
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
Government
Funder name
Epsom and St Helier University 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
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list