A randomized placebo-controlled clinical trial of topical photodynamic therapy with a nanoemulsion formulation of 5-aminolevulinic acid for the treatment of actinic keratosis

Biofrontera Bioscience GmbH0 sites260 target enrollmentMay 4, 2006

Overview

No summary available.

Registry

who.int

Start Date

May 4, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Are willing and able to sign informed consent form.
•2\. Men and women aged between 18 and 85 years.
•3\. Accept to abstain from sunbathing and the solarium during the study.
•4\. Have at least 3 clinically confirmed AK target lesions within the face or scalp (excluding eylids, lips and mucosa). The AK lesions must be discrete and quantifiable. The total AK lesion area should not exceed 200 cm2\.
•5\. Are free of any significant physical abnormalities (eg, tattoos, dermatoses) in the potential treatment area that may cause difficulty with examination or final evaluation.
•6\. Are willing to stop using moisturizers and any other topical treatments with anti\-aging products, vitamin A, vitamin C, and/or vitamin E containing ointments and creams, and green tea preparations during the study within the treatment area. Sunscreens will be allowed, but should not be applied in the treatment area within approximately 24 hours of a clinic visit with lesion count.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range

•1\. Have known hypersensitivity to ALA.
•2\. Have received any other medication known to affect AK 3 months before or during the study.
•3\. Are patients under immunosuppression therapy.
•4\. Suffer from porphyria.
•5\. Show hypersensitivity to porphyrins.
•6\. Suffer from photodermatoses.
•7\. Have inherited or acquired coagulation defects.
•8\. Receive medication with hypericin or any photosensitizer.
•9\. Have evidence of clinically significant, unstable medical conditions such as metastatic tumor or tumor with high probability of metastatic spread, cardiovascular (NYHA class III, IV), immunosuppressive, hematologic, hepatic, renal, neurologic, endocrine, collagen\-vascular, gastrointestinal disease
•10\. Have currently other malignant or benign tumors of the skin within the treatment area (e.g., malignant melanoma, basal cell carcinoma, squamous cell carcinoma).