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

NCT ID: NCT00304239

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-13
• Study Completion Date: 2007-01-23

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.

Conditions

Actinic Keratosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Metvix-PDT

Participants received Metvix-PDT (methyl aminolevulinate hydrochloride-Photodynamic therapy) 160 milligrams per gram (mg/g) cream on face and/or scalp for 3 hours on Day 0 and Day 7.

Group Type: EXPERIMENTAL

Metvix-PDT

Intervention Type: COMBINATION_PRODUCT

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-PDT

Participants received Vehicle cream (Vehicle-PDT) on face and/or scalp for 3 hours on Day 0 and Day 7.

Group Type: PLACEBO_COMPARATOR

Vehicle-PDT

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

Metvix-PDT

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.

Intervention Type: COMBINATION_PRODUCT

Vehicle-PDT

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 Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rolf M Szeimies, Professor

Role: PRINCIPAL_INVESTIGATOR

Klinik und Poliklinik für Dermatologie, Klinikum der Universität Regensburg

Locations

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

Countries

United States; Germany

References

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.

Reference Type: BACKGROUND

PMID: 12582393 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12775317 (View on PubMed)

Other Identifiers

2005-005015-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PC T405/05

Identifier Type: -

Identifier Source: org_study_id