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 | September 2010 |
Source | Galderma R&D |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 80 |
Est. completion date | October 2007 |
Est. primary completion date | |
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: - 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 therap |
Country | Name | City | State |
---|---|---|---|
United States | Dermresearch Inc | Austin | Texas |
United States | The Cleveland Clinic | Cleveland | Ohio |
United States | Texas Dermatology Research Institute | Dallas | Texas |
United States | Suzanne Bruce and Associates, PA | Houston | Texas |
United States | Laser and Skin Surgery Center | New York | New York |
United States | Dermatology Associates of Rochester | Rochester | New York |
United States | Spencer Dermatology and Skin Surgery | Saint Petersburg | Florida |
Lead Sponsor | Collaborator |
---|---|
Galderma R&D |
United States,
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. — 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary: 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 | Secondary: 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 |
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