Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the … (NCT00304239) | Clinical Trial Compass
CompletedPhase 3
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
United States, Germany131 participantsStarted 2006-03-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.