Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp

Completed · Phase 3

Conditions studied: Actinic Keratosis

In brief

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.

Key facts

Study ID

NCT00304239

Run by

Galderma R&D

People needed

131

Starts

2006-03-13

Expected to finish

2007-01-23

Last updated by the study team

2023-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ashish C. Bhatia — Naperville, Illinois, United States
• Joseph Fowler — Louisville, Kentucky, United States
• Robert T. Matheson — Portland, Oregon, United States
• Steven A. Davis — San Antonio, Texas, United States
• Hautklinik Heinrich Heine Universität — Düsseldorf, Germany
• Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main — Frankfurt, Germany
• Praxis Dr. Winfried Klövekorn — Gilching, Germany
• Klinik für Dermatologie und Venerologie Universitätsklinikum Schleswig-Holstein, Campus Lübeck — Lübeck, Germany
• Klinikum der Universität München, Klinikum und Poliklinik für Dermatologie und Allergologie — München, Germany
• Klinik und Poliklinik für Dermatologie, Klinikum der Universität Regensburg — Regensburg, Germany
• Praxis Dr. Klemm — Tutzing, Germany

Full record on ClinicalTrials.gov

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