Status:
COMPLETED
Metvix Photodynamic Therapy (PDT) Versus Cryotherapy in Participants With Primary Superficial Basal Cell Carcinoma
Lead Sponsor:
Galderma R&D
Conditions:
Superficial Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) methyl aminolevulinate (MAL) cream to cryotherapy, in treatment of participants with primary superficial basal cell ...
Detailed Description
BCC was a highly frequent skin malignancy, and accounts for approximately 75% of all non-melanoma skin cancers. It is the most common malignant tumour of any organ, mostly affecting head and neck (84%...
Eligibility Criteria
Inclusion
- A participant with superficial BCC lesion(s) suitable for entry was defined as a participant with:
- histologically confirmed diagnosis of primary superficial BCC lesion(s)
- BCC lesions suitable for cryotherapy
- males or females above 18 years of age
- written informed consent. In accordance with Amendment 2 (local amendment), only participant above 19 years of age were to be included in Austria.
Exclusion
- A participant or lesion fulfilling any of the following criteria was ineligible for inclusion:
- prior treatment of the BCC lesion(s)
- participant with more than 10 eligible BCC lesions
- a superficial BCC lesion with the largest diameter exceeding 15 mm on face/scalp, larger than 20 mm on extremities and neck and larger than 30 mm on the trunk
- a superficial BCC lesion with the largest diameter smaller than 6 mm
- participant with porphyria
- participant with Gorlin's syndrome
- pigmented superficial BCC lesion(s)
- morpheaform lesion(s)
- infiltrating lesion(s)
- 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 had to document a negative pregnancy test and use the pill or intrauterine device during the treatments and for at least one month thereafter
- conditions associated with a risk of poor protocol compliance.
- In Amendment 1 the following exclusion criteria were added:
- xeroderma pigmentosum lesion
- concurrent use of immunosuppressive medication.
Key Trial Info
Start Date :
October 18 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00469417
Start Date
October 18 1999
End Date
April 1 2005
Last Update
August 19 2024
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Graz
Graz, Austria, 8036
2
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, B3000
3
Helsinki University Central Hospital
Helsinki, Finland, 00029
4
Hôpital Sainte-Marguerite
Marseille, France, 13277