Additional identifiers
EudraCT number
2005-004262-16
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
That using topical photodynamic therapy (PDT) prior to Mohs micrographic surgery (as an adjunct) in the treatment of basal cell carcinoma (BCC) will overall, reduce the post-Mohs wound defect size (mm^2) when compared to Mohs micrographic surgery alone
Ethics approval
Approved by St Thomas' Hospital Research Ethics Committee on 06/12/2005, reference number: 05/Q0702/219
Study design
Single centre open randomised controlled pilot study with pre-entry concealment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Basal cell carcinoma (BCC)
Intervention
To assess whether the combination of PDT followed by Mohs micrographic surgery is superior to Mohs micrographic surgery alone in treating basal cell carcinoma in terms of reducing the post-Mohs wound defect and the mean number of stages required to achieve clearance
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. To measure and compare the post-Mohs wound defect surface area (mm^2) in the two groups
2. To compare the mean number of stages required to clear the lesion by Mohs' micrographic surgery in the two groups
3. To compare recurrence rates of BCC at 12 months post-operatively. The lesion response will be defined as one complete response (complete clearance) or zero incomplete response (incomplete clearance).
Secondary outcome measures
1. To assess whether there is any reduction in size (surface area, mm^2) of the lesion, clinically with PDT prior to Mohs (in the Metvix® PDT group) including assessment of fluorescence between the first and second sessions of PDT
2. Cosmetic outcome at months 3, 6 and 12 after the Mohs surgery
Overall trial start date
06/02/2006
Overall trial end date
01/10/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male or female subjects older than 18 years
2. The above should have a basal cell carcinoma at least 100 mm^2 in surface area and appropriate for treatment with Mohs micrographic surgery
3. Female subject of non-childbearing potential
4. Subject must be willing and capable of cooperating with the study protocol
5. Subject has to be able to read the patient information sheet as well as read and sign the informed consent form prior to any procedure
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. BCCs with less than 100 mm^2 in surface area
2. Clinically or histologically morphoeic basal cell carcinoma
3. Female of child-bearing potential
4. Subject with a history of porphyria, xeroderma pigmentosa or other photosensitive skin condition
5. Subject with known hypersensitivity to methyl 5-aminolevulinate, a similar compound or excipients of the cream
6. Subject who is at risk in terms of precautions and contraindications in the package insert for Metvix®
7. Subject who has participated in another investigational drug or device research study within 30 days of enrolment
8. Subject with a condition or who is in a situation, which in the investigators opinion may put the subject at significant risk, may confound the study results or may interfere significantly with the subjects participation in the study. This includes individuals unable to understand the implications or procedures of the trial, for example if they cannot adequately understand written or spoken English.
Recruitment start date
06/02/2006
Recruitment end date
01/10/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dermatological Surgery and Laser Unit
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Guy's and St Thomas' NHS Foundation Trust (UK)
Sponsor details
c/o Jackie Pullen
Research and Development
St Thomas' Street
London
SE1 9RT
United Kingdom
+44 (0)207 1885732
jackie.pullen@gstt.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Guy's and St Thomas' NHS Foundation 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