Photodynamic Therapy for Basal Cell Carcinoma of the Eyelid and Periocular Skin with methyl aminolevulinate - PDT for periocular BCC

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004085-41-GB

Enrollment

Registered

2008-04-04

Start date

2009-01-15

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Periocular basal cell carcinoma MedDRA version: 9.1 Level: LLT Classification code 10004146 Term: Basal cell carcinoma MedDRA version: 9.1 Level: LLT Classification code 10004148 Term: Basal cell carcinoma excision

Interventions

Trade Name: Metvix Pharmaceutical Form: Cream CAS Number: 79416-27-6 Other descriptive name: METHYL AMINOLEVULINATE HYDROCHLORIDE Concentration unit: mg/g milligram(s)/gram Concentration type: equal C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Primary Basal cell carcinoma in the lid or periocular region, sparing the lid margin by at least 5 mm Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Recurrent BCCs - A past medical history of skin disease or allergy ( especially to arachis oil ) which may be potentially likely to interfere with the treatment - A past medical history of porphyria - Pregnant and lactating mothers - Morpheaform BCC

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to evaluate the cure rate of topical PDT with methyl aminolevulinate for eyelid and periocular cutaneous BCCs.;Secondary Objective: The secondary objectives of this study are to report on any adverse effects observed as part of the study and to evaluate the patient response to the treatment through feedback from the patients.;Primary end point(s): No evidence of basal cell carcinoma either on the first or the second biopsy.	—

Measure

Time frame

Main Objective: The primary objective of this study is to evaluate the cure rate of topical PDT with methyl aminolevulinate for eyelid and periocular cutaneous BCCs.;Secondary Objective: The secondary objectives of this study are to report on any adverse effects observed as part of the study and to evaluate the patient response to the treatment through feedback from the patients.;Primary end point(s): No evidence of basal cell carcinoma either on the first or the second biopsy.

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Countries

United Kingdom

Outcome results

None listed

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