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

University of Oslo (UIO)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Genital Lichen Planus

Treatments: Drug: hexaminolevulinate; Drug: clobetasol propionate 0,05% ointment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01282515

ALH ELP 2/10

Details and patient eligibility

About

To compare the effect and side effects of photodynamic treatment and traditional topical steroid treatment in female genital erosive lichen planus

Full description

To assess the feasibility, efficacy and safety of hexyl 5-aminolevulinate-hydrocloride (HAL)-PDT in GELP in women.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

ELP active

Experimental group

Description:

one PDT treatment with 2 ml hexaminolevulinate 6 mg/ml gel

Treatment:

Drug: hexaminolevulinate

topical steroids

Active Comparator group

Description:

treatment with clobetasol propionate 0.05% ointment used daily for 6 weeks

Treatment:

Drug: clobetasol propionate 0,05% ointment