A Study of Topical Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) and a Phase III Comparative Treatment Study of HAL PDT in Female Genital Erosive Lichen Planus (GELP)
Information source: Oslo University Hospital
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Genital Erosive Lichen Planus
Intervention: clobetasolpropionate (Drug); hexaminolevulinate (Drug)
Phase: Phase 2/Phase 3
Status: Not yet recruiting
Sponsored by: Oslo University Hospital Overall contact:
anne lise helgesen, cand med, Phone: 0047 98634403, Email: anneliseord@yahoo.no
Summary
To compare the effect and side effects of photodynamic treatment and traditional topical
steroid treatment in female genital erosive lichen planus
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Percentage change of GELP score and/or VAS score 6 weeks after start of treatment.
Secondary outcome: Percentage change of GELP score and/or VAS score 6 months after start of treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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 and Contacts
anne lise helgesen, cand med, Phone: 0047 98634403, Email: anneliseord@yahoo.no
Rikshospitalet, OsloUniversity hospital, Oslo 0027, Norway
Additional Information
Starting date: August 2011
Last updated: January 24, 2011
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