Treatment of Female Genital Erosive Lichen Planus(GELP) With Hexaminolevulinate PDT
- Sponsor
- Oslo University Hospital
- Study ID
- NCT01282515
- Phase
- PHASE2/PHASE3
- Status
- Completed
Conditions
- Genital Lichen Planus
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- clobetasol propionate 0,05% ointment — DRUGcontinuously daily treatment for 6 weeks
- hexaminolevulinate — DRUGone PDT treatment
Study Details
To compare the effect and side effects of photodynamic treatment and traditional topical steroid treatment in female genital erosive lichen planus
Key Dates
- Start date
- Aug 31, 2011
- Status verified
- Mar 2021
- Primary completion
- Oct 31, 2014
- Completion
- Oct 31, 2014
Study Design
- Enrollment
- 40 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: ELP activeone PDT treatment with 2 ml hexaminolevulinate 6 mg/ml gel
- Active Comparator: topical steroidstreatment with clobetasol propionate 0.05% ointment used daily for 6 weeks
Primary Outcome Measure
Percentage change of GELP score and/or VAS score 6 weeks after start of treatment. [ Time Frame: 6 weeks ]