Metvix Photodynamic Therapy (PDT) Versus Cryotherapy in Participants With Primary Superficial Basal Cell Carcinoma

Launched by GALDERMA R&D · May 3, 2007

Keywords

ClinConnect Summary

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%) in fair-skinned people. Several non-pharmacological treatment modalities was used for BCC, including excision surgery, Moh's surgery, radiation, curettage/electrodesiccation and cryotherapy. The treatment used depends on the type, size, depth and localisation of the BCC lesion.

The use of PDT was attractive for the treatment of BCCs because of its efficiency, mild and local side effects and ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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 Criteria:
• 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.

Trial Officials