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 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...
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
- 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.
Key Trial Info
Start Date :
March 13 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2007
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00304239
Start Date
March 13 2006
End Date
January 23 2007
Last Update
July 3 2023
Active Locations (11)
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1
Ashish C. Bhatia
Naperville, Illinois, United States, 60563
2
Joseph Fowler
Louisville, Kentucky, United States, 40202
3
Robert T. Matheson
Portland, Oregon, United States, 97223
4
Steven A. Davis
San Antonio, Texas, United States, 78229