A Study of Topical Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) and a Phase III Comparative Treatment Study of HAL PDT in Female Genital Erosive Lichen Planus (GELP)
A Study of Topical Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) and a Phase III Comparative Treatment Study of HAL PDT in Female Genital Erosive Lichen Planus (GELP)
To compare the effect and side effects of photodynamic treatment and traditional topical steroid treatment in female genital erosive lichen planus
To assess the feasibility, efficacy and safety of hexyl 5-aminolevulinate-hydrocloride (HAL)-PDT in GELP in women.
Inclusion Criteria:
Women with symptomatically genital ELP, clinically verified by at least one doctor attended to the Vulva clinic.
Untreated for ELP for at least 4 weeks. Written Informed Consent signed Age 18 or above
Exclusion Criteria:
Current pelvic inflammatory disease, genital malignancy, or gynecological infection.
Known or suspected porphyria
Known allergy to hexaminolevulinate or similar compounds (e.g. hexaminolevulinate or aminolevulinic acid) Pregnancy and lactation Participation in other clinical study either concurrently or within the last 30 days