Phase
Condition
Carcinoma
Basal Cell Carcinoma
Warts
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Clinical diagnosis of BCC lesions verified by histology (2-3 mm punch biopsy)
- Males or females above 18 years of age.
- Written informed consent. AND Participants with high risk of surgical complications due to:
- Anticoagulant medication or bleeding disorders
- Cardiac risk factors
- Anaesthetic contraindications
- Poor surgical compliance because of participant refusal, dementia, or inability toperform wound care. OR
• Participants with "high-risk BCC lesion(s). A "high-risk" BCC lesion is defined as: A large BCC lesion with the largest diameter:
- Equal to or greater than 15 mm on extremities, except below the knees, where largestdiameter should be equal to or greater than 10 mm
- Equal to or greater than 20 mm on the trunk
- Equal to or greater than 15 mm in the face, or A lesion in the mid-face region (H-zoneaccording to Swanson) or on the ear In participants with more then 6 eligible lesions,the 6 lesions to be treated was randomly chosen.
Exclusion
Exclusion Criteria:
- Prior treatment of the lesion within 4 weeks.
- A pure morpheaform and/or highly infiltrated lesion assessed clinically and/or byhistology. A mixed nodular/morpheaform lesion which is not highly infiltrated (clinically) may be included.
- Participant with porphyria.
- Pigmented lesions.
- Known allergy to Metvix® or a similar compound.
- Participation in another clinical study either concurrently or within the last 30 days
- Participant with Gorlin's syndrome.
- Participant with Xeroderma pigmentosum
- Pregnant or breast-feeding (all women of child-bearing potential must document anegative pregnancy test and use contraception during the treatments and for at leastone month thereafter).
- Conditions associated with a risk of poor protocol compliance.
Study Design
Study Description
Connect with a study center
Department of Dermatology, St. George Hospital
Kogarah, New South Wales NSW 2217
AustraliaSite Not Available
South East Dermatology, The Belmont Specialist Clinic
Carnia, Queensland 4152
AustraliaSite Not Available
Department of Dermatology, Royal Adelaide Hospital
Adelaide, South Australia SA 5000
AustraliaSite Not Available
Dermatology Department, The Queen Elisabeth Hospital
Adelaide, South Australia SA 5011
AustraliaSite Not Available
Clinic B, Repatriation Campus, Austin & Repatriation Medical Centre
Heidelberg, Victoria VIC 3081
AustraliaSite Not Available
Fremantle Dermatology
Fremantle, Western Australia WA 6106
AustraliaSite Not Available
Dermatology Surgery & Laser Centre, The Perth Surgicentre
Perth, Western Australia WA 6151
AustraliaSite Not Available
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