Effect of penetration enhancers in topical photodynamic therapy
| ISRCTN | ISRCTN92678315 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92678315 |
| Protocol serial number | N0112112993 |
| Sponsor | Department of Health (UK) |
| Funder | Epsom and St Helier University Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 04/02/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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 Ian Pearson
Scientific
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 information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Response of skin lesion clinically by size change at 3 month follow ups. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 08/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Epsom and St Helier NHS Trust
Carshalton
SM5 1AA
United Kingdom
SM5 1AA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
