actinic keratosis
Conditions
Interventions
Trade Name: Metvix 160 mg / g Creme
Product Name: Metvix 160 mg/g Creme
Pharmaceutical Form: Cream
CAS Number: 79416-27-6
Current Sponsor code: P-1202
Other descriptive name: Methyl aminolevulinate hy
Sponsors
PhotoCure ASA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Clinical diagnosis of 4-10 previously untreated, not pigmented, non-hyperkeratotic AK lesions of 3 mm or more diameter of Grade 1 and/or 2 (see Section 6.1) of the face and/or scalp where other therapies are unacceptable or considered medically less appropriate. - Males or females above 18 years of age. - Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients with porphyria. - Patients immunosuppressed for idiopathic, disease specific or therapeutic reasons. - Known allergy to methyl aminolevulinate, a similar PDT compound or excipients of the cream. - Patients with history of hypersensitivity to nut products or other known protein antigens. - Participation in other clinical studies either currently or within the last 30 days. - Patients receiving local treatment (including cryotherapy and curretage) in face / scalp area within the last 30 days. - Patients receiving topical treatment (including imiquimod, 5-FU and diclofenac) in face / scalp area within the last 3 months. - Pregnant or breast-feeding: All women of child-bearing potential must use adequate contraception (oral contraceptives, intrauterine device, contraceptive skin patch, etc) during the treatment period and one month thereafter. In addition, they must have a negative pregnancy test prior to treatment. - Any conditions that may be associated with a risk of poor protocol compliance. - Patients currently receiving regular ultraviolet radiation therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the patient complete response rate of Metvix® PDT to that of vehicle PDT 3 months after last treatment in patients with multiple AK lesions on the face and/or scalp. ;Secondary Objective: - To compare local AEs (treatment site AEs) between Metvix® PDT and vehicle PDT. - To compare lesion complete response rate between Metvix® PDT and vehicle PDT 3 months after last treatment ;Primary end point(s): The primary efficacy end-point will be patient complete response rate, determined by clinical assessment (visual inspection and palpation) 3 months after last treatment. A patient will be considered a complete responder if all treated lesions show complete clinical response, as assessed by visual inspection and palpation. | — |
Countries
Germany
Outcome results
None listed