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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Oslo University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
PhotoCure
Information provided by (Responsible Party):
Anne Lise Helgesen, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01282515
First received: January 24, 2011
Last updated: August 23, 2012
Last verified: August 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282515

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

No publications provided

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
Study First Received: January 24, 2011
Last Updated: August 23, 2012
Health Authority: Norway: Norwegian Medicines Agency
Norway: Regional Ethics Commitee

Additional relevant MeSH terms:
Lichen Planus
Lichenoid Eruptions
Skin Diseases
Skin Diseases, Papulosquamous
Aminolevulinic Acid
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014