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

Launched by GALDERMA R&D · Mar 22, 2006

Keywords

ClinConnect Summary

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 increas...

Gender

ALL

Eligibility 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 therap