Treatment of Female Genital Erosive Lichen Planus(GELP) With Hexaminolevulinate PDT
NCT ID: NCT01282515
Last Updated: 2021-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2011-08-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ELP active
one PDT treatment with 2 ml hexaminolevulinate 6 mg/ml gel
hexaminolevulinate
one PDT treatment
topical steroids
treatment with clobetasol propionate 0.05% ointment used daily for 6 weeks
clobetasol propionate 0,05% ointment
continuously daily treatment for 6 weeks
Interventions
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clobetasol propionate 0,05% ointment
continuously daily treatment for 6 weeks
hexaminolevulinate
one PDT treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Untreated for ELP for at least 4 weeks. Written Informed Consent signed Age 18 or above
Exclusion Criteria
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
18 Years
FEMALE
No
Sponsors
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Photocure
INDUSTRY
Oslo University Hospital
OTHER
Responsible Party
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Anne Lise Helgesen
consultant dermatologist
Principal Investigators
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anne lise helgesen, md
Role: PRINCIPAL_INVESTIGATOR
research fellow
Locations
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Rikshospitalet, OsloUniversity hospital
Oslo, , Norway
Countries
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Other Identifiers
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ALH ELP 2/10
Identifier Type: -
Identifier Source: org_study_id
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