Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00304239
First received: March 16, 2006
Last updated: September 1, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Actinic Keratosis
Procedure: Photodynamic therapy with methyl aminolevulinate cream
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • Primary outcome: To compare the patient complete response rate of MAL PDT to that of vehicle PDT 3 months after the last treatment in patients with multiple actinic keratoses on the face and/or scalp

Secondary Outcome Measures:
  • The secondary outcomes: To compare local Adverse Events (treatment site Adverse Events (AEs) between MAL PDT and vehicle PDT; To compare the lesion complete response rate between MAL PDT and vehicle PDT 3 months after last treatment

Estimated Enrollment: 80
Study Start Date: March 2006
Study Completion Date: January 2007
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) 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • 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 therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304239

Locations
United States, Illinois
Ashish C. Bhatia
Naperville, Illinois, United States, 60563
United States, Kentucky
Joseph Fowler
Louisville, Kentucky, United States, 40202
United States, Oregon
Robert T. Matheson
Portland, Oregon, United States, 97223
United States, Texas
Steven A. Davis
San Antonio, Texas, United States, 78229
Germany
Hautklinik Heinrich Heine Universität
Dusseldorf, Germany, 40223
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt, Germany, 60590
Praxis Dr. Winfried Klövekorn
Gilching, Germany, 82205
Klinik für Dermatologie und Venerologie Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lubeck, Germany, 23538
Klinikum der Universität München, Klinikum und Poliklinik für Dermatologie und Allergologie
Munchen, Germany, 80337
Klinik und Poliklinik für Dermatologie, Klinikum der Universität Regensburg
Regensburg, Germany, 93053
Praxis Dr. Klemm
Tutzing, Germany, 82327
Sponsors and Collaborators
Galderma
Investigators
Principal Investigator: Rolf M Szeimies, Professor Klinik und Poliklinik für Dermatologie, Klinikum der Universität Regensburg
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00304239     History of Changes
Other Study ID Numbers: PC T405/05
Study First Received: March 16, 2006
Last Updated: September 1, 2010
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Galderma:
Methyl aminolevulinate
Photodynamic therapy
Aktilite CL128 LED light source
Multiple Actinic Keratosis

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Neoplasms
Precancerous Conditions
Skin Diseases
Aminolevulinic Acid
Methyl 5-aminolevulinate
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014