A trial comparing Metvix® photodynamic therapy (PDT) followed by Mohs micrographic surgery with Mohs micrographic surgery alone for the treatment of basal cell carcinoma (BCC)

Phase 1

• Conditions: Basal cell carcinoma; MedDRA version: 13.1Level: LLTClassification code 10042503Term: Superficial basal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2005-004262-16-GB
• Lead Sponsor: Guy's & St Thomas' NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-10
• Last Update Posted: 26 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1) Male or female subjects older than 18 years.
2) The above should have a basal cell carcinoma at least 100 mm2 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) ubject has to be able to read the Patient Information Sheet and read and sign the Informed Consent form prior to any procedure.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1) BCCs with less than 100 mm2 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified