5-aminolevulinic-acid-hexyl-ester and Lichen-Planus

Genital erosive lichen planus (GELP) is a chronic inflammatory disease, in women characterized by painful vulvar and vaginal erosions. To prepare for a clinical trial on photodynamic treatment (PDT), we applied hexyl 5-aminolevulinate hydrochloride (HAL) in clinically normal and affected mucosa in 12 women with GELP using two different doses (6.25 or 50mg/ml). Biopsies were taken after 30 min and 3h. The biodistribution of HAL, measured as photoactive protoporphyrin IX (PpIX), was studied using non-invasive superficial fluorescence measurements and microscopic fluorescence photometry. More PpIX was detected after application of 12.5mg HAL than after 100mg, with large inter-individual variations. PpIX levels after 3h were overall higher than after 30 min. PpIX fluorescence was not detected in skin distant to the genital area. In conclusion, 6.25mg/ml HAL applied for 3h seems adequate for HAL absorption and conversion to PpIX in submucosal inflammatory and epithelial cells and can be used in a PDT trial of GELP.

Topics: Administration, Topical; Aminolevulinic Acid; Dose-Response Relationship, Drug; Female; Genital Diseases, Female; Humans; Lichen Planus; Metabolic Clearance Rate; Photochemotherapy; Photosensitizing Agents; Protoporphyrins; Tissue Distribution; Treatment Outcome