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 is to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the the LED light source Aktilite CL128, in treatment of patients with multiple actinic keratosis (sun-damaged skin) on the face and / or scalp

Key facts

Study ID

NCT00306800

Run by

Galderma R&D

People needed

80

Starts

2007-09-01

Expected to finish

2007-10-01

Last updated by the study team

2021-02-18

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…

• Patients with porphyria.
• Patients immunosuppressed for idiopathic, disease specific or therapeutic reasons.
• Known allergy to MAL, 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 therap

Where it is running

• Spencer Dermatology and Skin Surgery — St. Petersburg, Florida, United States
• Laser and Skin Surgery Center — New York, New York, United States
• Dermatology Associates of Rochester — Rochester, New York, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• Dermresearch Inc — Austin, Texas, United States
• Texas Dermatology Research Institute — Dallas, Texas, United States
• Suzanne Bruce and Associates, PA — Houston, Texas, United States

Full record on ClinicalTrials.gov

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