Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Metvix-PDT; Vehicle-PDT
Intervention description: Metvix 160 mg/g Cream was applied for 3 hours with occlusive dressing, and illumination with non-coherent red light using the Aktilite CL128 lamp, with a total light dose 37 Joule/square centimeter (J/cm²). All eligible lesions on the participant were treated twice with an interval of 1 week between treatments.; Vehicle Cream was applied for 3 hours with occlusive dressing, and illumination with non-coherent red light using the Aktilite CL128 lamp, with a total light dose 37 J/cm². All eligible lesions on the participant were treated twice with an interval of 1 week between treatments.
Intervention MeSH terms: Methyl 5-aminolevulinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double blinded
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Methyl aminolevulinate; Photodynamic therapy; Aktilite CL128 LED light source; Multiple Actinic Keratosis

Summary:

      The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) with
      methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the Light-emitting diode
      (LED) light source Aktilite CL128, in treatment of participants with multiple actinic
      keratosis (sun-damaged skin) on the face and/or scalp.
    

Eligibility 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 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.

        Exclusion Criteria:

          -  Participants with porphyria.

          -  Participants immunosuppressed for idiopathic, disease specific or therapeutic reasons.

          -  Known allergy to MAL, a similar PDT compound or excipients of the cream.

          -  Participants 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.

          -  Participants receiving local treatment (including cryotherapy and curretage) in face /
             scalp area within the last 30 days.

          -  Participants 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.

          -  Participants currently receiving regular ultraviolet radiation therapy.