Treatment of Female Genital Erosive Lichen Planus(GELP) NCT01282515

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Completed

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.

Recruitment information / eligibility
Status	Completed
Enrollment	40
Est. completion date	October 2014
Est. primary completion date	October 2014
Accepts healthy volunteers	No
Gender	Female
Age group	18 Years and older
Eligibility	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

Drug:
• clobetasol propionate 0,05% ointment
continuously daily treatment for 6 weeks
• hexaminolevulinate
one PDT treatment

Locations
Country	Name	City	State
Norway	Rikshospitalet, OsloUniversity hospital	Oslo

Sponsors *(2)*
Lead Sponsor	Collaborator
Oslo University Hospital	Photocure

Norway,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change of GELP score and/or VAS score 6 weeks after start of treatment.		6 weeks
Secondary	Percentage change of GELP score and/or VAS score 6 months after start of treatment.		6 months