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

Last updated: February 16, 2021
Sponsor: Galderma R&D
Overall Status: Completed

Phase

3

Condition

Sun Poisoning

Warts

Squamous Cell Carcinoma

Treatment

N/A

Clinical Study ID

NCT00306800
PC T404/05
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of 4-10 previously untreated, not pigmented, non-hyperkeratotic AKlesions of 3 mm or more diameter of Grade 1 and/or 2 of the face and/or scalp whereother therapies are unacceptable or considered medically less appropriate.
  • Males or females above 18 years of age.
  • Written informed consent

Exclusion

Exclusion Criteria:

  • 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 proteinantigens.
  • 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) inface / scalp area within the last 3 months.
  • Pregnant or breast-feeding: All women of child-bearing potential must use adequatecontraception (oral contraceptives, intrauterine device, contraceptive skin patch,etc) during the treatment period and one month thereafter. In addition, they must havea 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

Study Design

Total Participants: 80
Study Start date:
September 01, 2007
Estimated Completion Date:
October 31, 2007

Study 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) have been used for the activation of PAP, which absorbs light in the range of 400-700 nm. The present study uses the Aktilite CL 128 lamp. Aktilite 128 is based on LED technology and emits a narrow red light spectrum with an average wavelength of 630 (+/-5) nm. This study is similar to two other studies performed, on which the U.S. approval of Metvixia® cream is based except for the light source used. This study is 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.

Connect with a study center

  • Spencer Dermatology and Skin Surgery

    Saint Petersburg, Florida 33716-1115
    United States

    Site Not Available

  • Laser and Skin Surgery Center

    New York, New York 10016
    United States

    Site Not Available

  • Dermatology Associates of Rochester

    Rochester, New York 14623
    United States

    Site Not Available

  • The Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Dermresearch Inc

    Austin, Texas 78759
    United States

    Site Not Available

  • Texas Dermatology Research Institute

    Dallas, Texas 75230
    United States

    Site Not Available

  • Suzanne Bruce and Associates, PA

    Houston, Texas 77056
    United States

    Site Not Available

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