Actinic Keratosis Clinical Trial
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
Verified date | August 2022 |
Source | Galderma R&D |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 131 |
Est. completion date | January 23, 2007 |
Est. primary completion date | January 23, 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Hautklinik Heinrich Heine Universität | Dusseldorf | |
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 | Lubeck | |
Germany | Klinikum der Universität München, Klinikum und Poliklinik für Dermatologie und Allergologie | Munchen | |
Germany | Klinik und Poliklinik für Dermatologie, Klinikum der Universität Regensburg | Regensburg | |
Germany | Praxis Dr. Klemm | Tutzing | |
United States | Joseph Fowler | Louisville | Kentucky |
United States | Ashish C. Bhatia | Naperville | Illinois |
United States | Robert T. Matheson | Portland | Oregon |
United States | Steven A. Davis | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Galderma R&D |
United States, Germany,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participant Complete Response Rate (CRR) | Participant complete response rate was defined as the percentage of participants with complete response. Complete response was defined as the complete disappearance of the lesion determined by clinical assessment (visual inspection and palpation) by an investigator. | At Week 13 | |
Secondary | Lesion Complete Response Rate | Lesion complete response rate was defined as the percentage of pre-existing and treated lesions at baseline that were assessed as clear (complete disappearance of the lesion, visually and by palpation) after treatment. Percentage of lesions reported by location. | At Week 13 | |
Secondary | Number of Participants With at Least One Treatment Site Adverse Events | An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Number of participants with at least one treatment site adverse events were reported. | From start of study drug administration up to Week 13 |
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