Status:
COMPLETED
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
Lead Sponsor:
Galderma R&D
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00306800
Start Date
September 1 2007
End Date
October 1 2007
Last Update
February 18 2021
Active Locations (7)
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1
Spencer Dermatology and Skin Surgery
St. Petersburg, Florida, United States, 33716-1115
2
Laser and Skin Surgery Center
New York, New York, United States, 10016
3
Dermatology Associates of Rochester
Rochester, New York, United States, 14623
4
The Cleveland Clinic
Cleveland, Ohio, United States, 44195