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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Anne Lise Helgesen, Oslo University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01282515
First Posted: January 25, 2011
Last Update Posted: August 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Photocure
Information provided by (Responsible Party):
Anne Lise Helgesen, Oslo University Hospital
  Purpose
To compare the effect and side effects of photodynamic treatment and traditional topical steroid treatment in female genital erosive lichen planus

Condition Intervention Phase
Genital Erosive Lichen Planus Drug: clobetasolpropionate Drug: hexaminolevulinate Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Anne Lise Helgesen, Oslo University Hospital:

Primary Outcome Measures:
  • Percentage change of GELP score and/or VAS score 6 weeks after start of treatment. [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Percentage change of GELP score and/or VAS score 6 months after start of treatment. [ Time Frame: 6 months ]

Estimated Enrollment: 48
Study Start Date: August 2011
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ELP active
one PDT treatment
Drug: hexaminolevulinate
one PDT treatment
Active Comparator: topical steroids Drug: clobetasolpropionate
continuously treatment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282515


Locations
Norway
Rikshospitalet, OsloUniversity hospital
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Photocure
  More Information

Responsible Party: Anne Lise Helgesen, consultant dermatologist, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01282515     History of Changes
Other Study ID Numbers: ALH ELP 2/10
First Submitted: January 24, 2011
First Posted: January 25, 2011
Last Update Posted: August 24, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents