Photodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma

Launched by GALDERMA R&D · May 10, 2007

Keywords

ClinConnect Summary

A participants were randomised to PDT with Metvix cream or PDT with placebo cream. All eligible basal cell carcinoma (BCC) lesions within a participant received same treatment. All participants received two consecutive treatments one week apart. At the 3-months follow-up visit, lesions with no clinical response or progression were surgically excised. Lesions with partial response 50 percent (%) or greater reduction on lesion area) were re-treated; if they do not show complete response three months later, they were surgically excised. Lesions with complete response were surgically excised 6 ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• A participant that is ineligible for inclusion is a participant fulfilling any of the following criteria:
• • Participants with porphyria.
• • Participants with Gorlin's syndrome.
• • Participants with Xeroderma pigmentosum.
• • Participants concurrently receiving immunosuppressive medication.
• • Participants with a history of arsenic exposure.
• • Participants with BCC arising in a previous radiated area.
• • 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 Exclusion Criteria:
• • A nodular BCC lesion in periorbital area, ears and nasolabial fold.
• • A nodular BCC lesion with the longest diameter less than 6 millimeter (mm) or larger than 15 mm in face/scalp, larger than 20 mm on extremities and neck and larger than 30 mm on truncus.
• • Pigmented nodular BCC lesion(s)
• • Morpheaform nodular BCC lesion(s).
• • Infiltrating nodular BCC lesion(s).
• • Prior treatment of the BCC lesion(s).

Trial Officials