Metvix PDT in Participant With "High Risk" Basal Cell Carcinoma

Launched by GALDERMA R&D · May 14, 2007

Keywords

ClinConnect Summary

Prospective, open, multicenter study. The high risk BCC lesions were treated with Metvix cream. A biopsy confirming the diagnosis of each BCC lesion should have been taken within 6 months prior to treatment. The participants was receive one or two treatment cycles each consisting of two Metvix PDT treatments 7 days apart (Lesions that did not respond completely after three months received a second PDT treatment cycle).

The primary end-point was the histologically confirmed complete response rate within a participant (No BCC cells in the biopsy taken 3 months after the last treatment).

Gender

ALL

Eligibility criteria

• 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 to perform 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 largest diameter 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-zone according to Swanson) or on the ear In participants with more then 6 eligible lesions, the 6 lesions to be treated was randomly chosen.
• Exclusion Criteria:
• • Prior treatment of the lesion within 4 weeks.
• • A pure morpheaform and/or highly infiltrated lesion assessed clinically and/or by histology. 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 a negative pregnancy test and use contraception during the treatments and for at least one month thereafter).
• • Conditions associated with a risk of poor protocol compliance.