A trial comparing Metvix® photodynamic therapy followed by Mohs micrographic surgery against Mohs micrographic surgery alone for the treatment of basal cell carcinoma

ISRCTN	ISRCTN03814856
DOI	https://doi.org/10.1186/ISRCTN03814856
Clinical Trials Information System (CTIS)	2005-004262-16
Protocol serial number	N/A
Sponsor	Guy's and St Thomas' NHS Foundation Trust (UK)
Funder	Guy's and St Thomas' NHS Foundation Trust (UK)

Submission date: 03/02/2006
Registration date: 03/04/2006
Last edited: 16/05/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Habib Kurwa
Scientific

Dermatological Surgery and Laser Unit
St John's Institute of Dermatology
St Thomas' Hospital
London
SE1 7EH
United Kingdom

Study information

Primary study design	Interventional
Study design	Single centre open randomised controlled pilot study with pre-entry concealment
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A trial comparing Metvix® photodynamic therapy followed by Mohs micrographic surgery against Mohs micrographic surgery alone for the treatment of basal cell carcinoma
Study objectives	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(s)	Approved by St Thomas' Hospital Research Ethics Committee on 06/12/2005, reference number: 05/Q0702/219
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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
Completion date	01/10/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	20
Key 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
Key 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.
Date of first enrolment	06/02/2006
Date of final enrolment	01/10/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Dermatological Surgery and Laser Unit

London
SE1 7EH
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?
Basic results			16/05/2019	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

16/05/2019: Added clinicaltrialsregister.eu link to basic results (scientific).