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

March 14, 2021 updated by: Anne Lise Helgesen, Oslo University Hospital

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0027
        • Rikshospitalet, OsloUniversity hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ELP active
one PDT treatment with 2 ml hexaminolevulinate 6 mg/ml gel
Drug: hexaminolevulinate
one PDT treatment
Active Comparator: topical steroids
treatment with clobetasol propionate 0.05% ointment used daily for 6 weeks
Drug: clobetasol propionate 0,05% ointment
continuously daily treatment for 6 weeks
Other Names:
  • Dermovate 0.05% ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage change of GELP score and/or VAS score 6 weeks after start of treatment.
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage change of GELP score and/or VAS score 6 months after start of treatment.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Photocure

Investigators

  • Principal Investigator: anne lise helgesen, md, Research Fellow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 24, 2011

First Submitted That Met QC Criteria

January 24, 2011

First Posted (Estimate)

January 25, 2011

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 14, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALH ELP 2/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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