Treatment of Female Genital Erosive Lichen Planus(GELP) With Hexaminolevulinate PDT
- Conditions
- Genital Lichen Planus
- Interventions
- Registration Number
- NCT01282515
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
To compare the effect and side effects of photodynamic treatment and traditional topical steroid treatment in female genital erosive lichen planus
- Detailed Description
To assess the feasibility, efficacy and safety of hexyl 5-aminolevulinate-hydrocloride (HAL)-PDT in GELP in women.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ELP active hexaminolevulinate one PDT treatment with 2 ml hexaminolevulinate 6 mg/ml gel topical steroids clobetasol propionate 0,05% ointment treatment with clobetasol propionate 0.05% ointment used daily for 6 weeks
- Primary Outcome Measures
Name Time Method Percentage change of GELP score and/or VAS score 6 weeks after start of treatment. 6 weeks
- Secondary Outcome Measures
Name Time Method Percentage change of GELP score and/or VAS score 6 months after start of treatment. 6 months
Trial Locations
- Locations (1)
Rikshospitalet, OsloUniversity hospital
🇳🇴Oslo, Norway