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

Conditions: Periocular basal cell carcinoma
MedDRA version: 9.1Level: LLTClassification code 10004146Term: Basal cell carcinoma
MedDRA version: 9.1Level: LLTClassification code 10004148Term: Basal cell carcinoma excision

Registration Number: EUCTR2007-004085-41-GB

Lead Sponsor: The Royal Wolverhampton Hospitals NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 15

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

-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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures