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

NCT ID: NCT01282515

Last Updated: 2021-03-17

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-10-31

Brief Summary

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

Detailed Description

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

Conditions

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Genital Lichen Planus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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ELP active

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

Group Type EXPERIMENTAL

hexaminolevulinate

Intervention Type DRUG

one PDT treatment

topical steroids

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

Group Type ACTIVE_COMPARATOR

clobetasol propionate 0,05% ointment

Intervention Type DRUG

continuously daily treatment for 6 weeks

Interventions

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clobetasol propionate 0,05% ointment

continuously daily treatment for 6 weeks

Intervention Type DRUG

hexaminolevulinate

one PDT treatment

Intervention Type DRUG

Other Intervention Names

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Dermovate 0.05% ointment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Photocure

INDUSTRY

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anne Lise Helgesen

consultant dermatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Norway

Other Identifiers

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ALH ELP 2/10

Identifier Type: -

Identifier Source: org_study_id

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