Treatment of Female Genital Erosive Lichen Planus(GELP) With Hexaminolevulinate PDT

Oslo University Hospital40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Genital Lichen Planus

Interventions

clobetasol propionate 0,05% ointmentDRUG

continuously daily treatment for 6 weeks

hexaminolevulinateDRUG

one PDT treatment

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rikshospitalet, OsloUniversity hospital

Oslo, Norway

Outcomes

Primary Outcomes

Percentage change of GELP score and/or VAS score 6 weeks after start of treatment.

Time frame: 6 weeks

Secondary Outcomes

Percentage change of GELP score and/or VAS score 6 months after start of treatment.

Time frame: 6 months

Data from ClinicalTrials.gov

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