Condition category
Cancer
Date applied
03/02/2006
Date assigned
03/04/2006
Last edited
22/08/2012
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 Habib Kurwa

ORCID ID

Contact details

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

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 investigator’s opinion may put the subject at significant risk, may confound the study results or may interfere significantly with the subject’s 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

Publication citations

Additional files

Editorial Notes