Phase II/III study to investigate the efficacy of 5-aminolaevulinic acid (ALA)-based photodynamic therapy in the treatment of Bowen's disease, actinic keratoses and study the effect of dose fractionation for superficial basal cell carcinomas
| ISRCTN | ISRCTN93864182 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93864182 |
| Protocol serial number | N0436118001 |
| Sponsor | Department of Health (UK) |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 07/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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 F Roberts
Scientific
Scientific
Clinical Oncology
Cookridge Hospital
Hospital Lane
Leeds
LS16 6QB
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised active-controlled parallel-group trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Phase II/III study to investigate the efficacy of 5-aminolaevulinic acid (ALA)-based photodynamic therapy in the treatment of Bowen's disease, actinic keratoses and study the effect of dose fractionation for superficial basal cell carcinomas |
| Study objectives | To continue to investigate the efficacy of ALA-based photodynamic therapy in the treatment of Bowen's disease and actinic keratoses. To study the effect of dose fractionation for superficial basal cell carcinomas using a randomised trial. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Bowen's disease |
| Intervention | Controlled trial without randomisation; Randomised controlled trial, Random allocation to: 1 Standard photodynamic therapy for superficial basal cell carcinoma 2 Dose fractionated photodynamic therapy |
| Intervention type | Other |
| Primary outcome measure(s) |
Complete remission of skin tumour and future recurrence. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/02/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Recruited from clinical oncology consultants to whom patients are referred at a district general hospital. Also direct from consultant dermatologists/plastic surgeons in Leeds and Airedale. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/02/2002 |
| Date of final enrolment | 01/02/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Cookridge Hospital
Leeds
LS16 6QB
United Kingdom
LS16 6QB
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
