Back to resultsTreatment of Female Genital Erosive Lichen Planus(GELP) With Hexaminolevulinate PDT
Primary Purpose
Genital Lichen Planus
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
clobetasol propionate 0,05% ointment
hexaminolevulinate
Sponsored by
About this trial
This is an interventional treatment trial for Genital Lichen Planus
Eligibility 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
Sites / Locations
- Rikshospitalet, OsloUniversity hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ELP active
topical steroids
Arm Description
one PDT treatment with 2 ml hexaminolevulinate 6 mg/ml gel
treatment with clobetasol propionate 0.05% ointment used daily for 6 weeks
Outcomes
Primary Outcome Measures
Percentage change of GELP score and/or VAS score 6 weeks after start of treatment.
Secondary Outcome Measures
Percentage change of GELP score and/or VAS score 6 months after start of treatment.
Full Information
NCT ID
NCT01282515
First Posted
January 24, 2011
Last Updated
March 14, 2021
Sponsor
Oslo University Hospital
Collaborators
Photocure
1. Study Identification
Unique Protocol Identification Number
NCT01282515
Brief Title
Treatment of Female Genital Erosive Lichen Planus(GELP) With Hexaminolevulinate PDT
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 Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Photocure
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the effect and side effects of photodynamic treatment and traditional topical steroid treatment in female genital erosive lichen planus
Detailed Description
To assess the feasibility, efficacy and safety of hexyl 5-aminolevulinate-hydrocloride (HAL)-PDT in GELP in women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Lichen Planus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ELP active
Arm Type
Experimental
Arm Description
one PDT treatment with 2 ml hexaminolevulinate 6 mg/ml gel
Arm Title
topical steroids
Arm Type
Active Comparator
Arm Description
treatment with clobetasol propionate 0.05% ointment used daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
clobetasol propionate 0,05% ointment
Other Intervention Name(s)
Dermovate 0.05% ointment
Intervention Description
continuously daily treatment for 6 weeks
Intervention Type
Drug
Intervention Name(s)
hexaminolevulinate
Intervention Description
one PDT treatment
Primary Outcome Measure Information:
Title
Percentage change of GELP score and/or VAS score 6 weeks after start of treatment.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Percentage change of GELP score and/or VAS score 6 months after start of treatment.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
anne lise helgesen, md
Organizational Affiliation
research fellow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rikshospitalet, OsloUniversity hospital
City
Oslo
ZIP/Postal Code
0027
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Treatment of Female Genital Erosive Lichen Planus(GELP) With Hexaminolevulinate PDT
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