Status:
COMPLETED
PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Call Carcinoma
Lead Sponsor:
Galderma R&D
Conditions:
Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Photodynamic therapy (PDT) was the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulated more photosensitiser than no...
Detailed Description
A participant was randomised to PDT with Metvix® cream or PDT with placebo cream. All eligible Basal cell carcinoma (BCC) lesions within a participant had got the same treatment. All participants got ...
Eligibility Criteria
Inclusion
- A participant with primary, nodular BCC lesion(s) suitable for entry is defined as a participant with
- Clinically diagnosed primary nodular BCC lesion(s).
- Histologically confirmed diagnosis of BCC.
- BCC lesions suitable for simple excision surgery.
- Males or females above 18 years of age.
- Written informed consent.
Exclusion
- A participant that is ineligible for inclusion is a participant fulfilling any of the following criteria:
- Participants with porphyria.
- Participant with Gorlin's syndrome.
- Participant with Xeroderma pigmentosum.
- Participants concurrently receiving immunosuppressive medication.
- Participants with a history of arsenic exposure.
- Known allergy to Metvix®, a similar PDT compound or excipients of the cream.
- Participation in other clinical studies either concurrently or within the last 30 days.
- Pregnant or breast-feeding: All women of child-bearing potential must use adequate contraception (e.g. barrier methods, oral contraceptives or intrauterine device) during the treatment period and one month thereafter. In addition, they must have a negative pregnancy test prior to treatment.
- Conditions associated with a risk of poor protocol compliance.
- Lesion
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2002
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00472043
Start Date
October 1 2000
End Date
September 30 2002
Last Update
August 6 2024
Active Locations (7)
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1
Dept. of Dermatology, Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
2
Dermatology Dept., St. George Hospital
Kogarah, New South Wales, Australia, 2217
3
Dermatology Centre
Liverpool, New South Wales, Australia, 2170
4
Dr. Michael Freeman
Benowa, Queensland, Australia, 4217