FLUORESCENT DETECTION WITH METHYL AMINOLEVULINATE OF BASAL CELL CARCINOMA: TO ASSESS THE ACCURACY OF THIS TECHNIQUE BY COMPARISON WITH RESECTION MARGIN LEFT BY MOH’S MICROGRAPHIC SURGERY AFTER DIFFERENT APPLICATION TIMES OF THE METHYL AMINOLEVULINATE - Evaluation of the efficacy of Fluorescence diagnosis with Metvix cream

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005769-12-GB

Enrollment

Registered

2006-04-13

Start date

2006-06-12

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal Cell Carcinoma MedDRA version: 8.1 Level: LLT Classification code 10004146

Interventions

Trade Name: Metvix 160mg/g cream Product Name: Metvix 160mg/g cream Product Code: P-1202 Pharmaceutical Form: Cream INN or Proposed INN:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female subject older than 18 years. - Biopsy-confirmed Basal Cell Carcinoma (primary nodular, primary morphoeic, primary infiltrative, primary multifocal or recurrent lesions only) suitable for Moh’s micrographic surgery. - Female subject of childbearing potential, using an effective birth control method and having a negative pregnancy test at the beginning of the study, or female subject of non childbearing potential . Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Hyperkeratotic BCC. - Pigmented BCC lesion. - Subject in whom Moh’s micrographic surgery in inadvisable. - BCC lesions located on eyelid and/or in the canthal area. - Subject with known porphyria and/or other photosensitive disorder. - Female subject who is pregnant, nursing or planning a pregnancy during the study. - Subject who has been treated in the study area with any following topical treatment within the specified washout period: 5-FU 3 months Cryotherapy 3 months PDT 3 months Diclofenac sodium 3 months Retinoids 2 weeks Corticosteroids 2 weeks Imiquimod 3 months

Design outcomes

Primary

Measure	Time frame
Secondary Objective: ;Primary end point(s): The surface area of the fluorescing selected lesion and the surface area of the final Moh's micrographic wound resection will be compared.; Main Objective: To show that Fluorescent Detection (FD) using Methyl aminolevulinate (Metvix®) is a useful adjunctive diagnostic tool in the management of basal cell carcinoma’s treatment. 3 application times of Metvix® cream will be studied: 1 hour 30 minutes, 2 hours and 2 hours and 30 minutes.	—

Measure

Time frame

Secondary Objective: ;Primary end point(s): The surface area of the fluorescing selected lesion and the surface area of the final Moh's micrographic wound resection will be compared.; Main Objective: To show that Fluorescent Detection (FD) using Methyl aminolevulinate (Metvix®) is a useful adjunctive diagnostic tool in the management of basal cell carcinoma’s treatment. 3 application times of Metvix® cream will be studied: 1 hour 30 minutes, 2 hours and 2 hours and 30 minutes.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026