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

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. Identifier: NCT01282515
Recruitment Status : Unknown
Verified August 2012 by Anne Lise Helgesen, Oslo University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 25, 2011
Last Update Posted : August 24, 2012
Information provided by (Responsible Party):
Anne Lise Helgesen, Oslo University Hospital

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

Condition or disease Intervention/treatment Phase
Genital Erosive Lichen Planus Drug: clobetasolpropionate Drug: hexaminolevulinate Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
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)
Study Start Date : August 2011
Estimated Primary Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ELP active
one PDT treatment
Drug: hexaminolevulinate
one PDT treatment
Active Comparator: topical steroids Drug: clobetasolpropionate
continuously treatment

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

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

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

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

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 identifier (NCT number): NCT01282515

Rikshospitalet, OsloUniversity hospital
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital

Responsible Party: Anne Lise Helgesen, consultant dermatologist, Oslo University Hospital Identifier: NCT01282515     History of Changes
Other Study ID Numbers: ALH ELP 2/10
First Posted: January 25, 2011    Key Record Dates
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