Clinical trial NCT00304239: Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
Official title: A Multicenter, Double Blind, Vehicle-controlled, Randomized Study of Photodynamic Therapy (PDT) With Metvix 160 mg/g Cream and Aktilite CL128 LED Light in Patients With Multiple Actinic Keratosis on the Face and/or Scalp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Keywords: Methyl aminolevulinate
Photodynamic therapy
Aktilite CL128 LED light source
Multiple Actinic Keratosis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2006-03-17
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Actinic keratoses are pre-malignant skin lesions, which may develop to squamous cell carcinomas (SCC). They are usually small, thin, erythematous, de-squamating lesions on light exposed atrophic skin and the lesions are often multiple.

Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulate more photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon illumination.

For skin diseases, such as actinic keratosis (AK), there has been an increasing interest in using topically applied precursors of the photoactive porphyrins (PAP). The most commonly used precursors have been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug contains methyl aminolevulinate, which penetrates the lesions well and shows high lesion selectivity.

Different light sources (i.e. CureLight, Aktilite CL16 and Aktilite CL128) had been used for the activation of PAP, which absorbs light in the range of 400-700 nanometer (nm). The present study used the Aktilite CL 128 lamp. Aktilite 128 was based on LED technology and emits a narrow red light spectrum with an average wavelength of 630 (+/-5) nm. This study was similar to two other studies performed, on which the U.S. approval of Metvixia cream was based except for the light source used. This study was one of two studies performed to document the safety and efficacy of the Aktilite CL 128 lamp when used in combination with Metvixia cream.

Previous studies have shown that the risks attributed to Metvixia PDT are few and related mainly to transient pain and local erythema during and shortly after treatment. These reactions are part of the expected local phototoxicity reaction. PDT offers an advantage to other treatment modalities for actinic keratosis, being a non-invasive treatment available on an outpatient basis. Several separate lesions can be treated simultaneously and the same lesion(s) can be treated repeatedly with success. There are no known systemic toxicity or interaction with other medication. The treatment is also lesion selective, leaving the surrounding tissue intact and functional, also allowing excellent cosmetic results after treatment.

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.

Primary outcomes:
measure: Participant Complete Response Rate (CRR)
timeFrame: At Week 13
Secondary outcomes:
measure: Lesion Complete Response Rate
timeFrame: At Week 13
measure: Number of Participants With at Least One Treatment Site Adverse Events
timeFrame: From start of study drug administration up to Week 13
Other outcomes:
Locations:
city: Naperville
country: United States
facility: Ashish C. Bhatia
state: Illinois
city: Louisville
country: United States
facility: Joseph Fowler
state: Kentucky
city: Portland
country: United States
facility: Robert T. Matheson
state: Oregon
city: San Antonio
country: United States
facility: Steven A. Davis
state: Texas
city: Dusseldorf
country: Germany
facility: Hautklinik Heinrich Heine Universität
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
city: Gilching
country: Germany
facility: Praxis Dr. Winfried Klövekorn
city: Lubeck
country: Germany
facility: Klinik für Dermatologie und Venerologie Universitätsklinikum Schleswig-Holstein, Campus Lübeck
city: Munchen
country: Germany
facility: Klinikum der Universität München, Klinikum und Poliklinik für Dermatologie und Allergologie
city: Regensburg
country: Germany
facility: Klinik und Poliklinik für Dermatologie, Klinikum der Universität Regensburg
city: Tutzing
country: Germany
facility: Praxis Dr. Klemm
Study officials:
affiliation: Klinik und Poliklinik für Dermatologie, Klinikum der Universität Regensburg
name: Rolf M Szeimies, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pariser DM, Lowe NJ, Stewart DM, Jarratt MT, Lucky AW, Pariser RJ, Yamauchi PS. Photodynamic therapy with topical methyl aminolevulinate for actinic keratosis: results of a prospective randomized multicenter trial. J Am Acad Dermatol. 2003 Feb;48(2):227-32. doi: 10.1067/mjd.2003.49.
citation: Freeman M, Vinciullo C, Francis D, Spelman L, Nguyen R, Fergin P, Thai KE, Murrell D, Weightman W, Anderson C, Reid C, Watson A, Foley P. A comparison of photodynamic therapy using topical methyl aminolevulinate (Metvix) with single cycle cryotherapy in patients with actinic keratosis: a prospective, randomized study. J Dermatolog Treat. 2003 Jun;14(2):99-106. doi: 10.1080/09546630310012118.