Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
04/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ian Pearson

ORCID ID

Contact details

Epsom and St Helier NHS Trust
Department of Dermatology
St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
+44 (0)20 8296 2000

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes