Rikshospitalet, OsloUniversity hospital
Oslo, 0027, Norway
Completed
NCT Number: NCT01282515
Treatment of Female Genital Erosive Lichen Planus(GELP) With Hexaminolevulinate PDT
To compare the effect and side effects of photodynamic treatment and traditional topical steroid treatment in female genital erosive lichen planus
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
About this study
To assess the feasibility, efficacy and safety of hexyl 5-aminolevulinate-hydrocloride (HAL)-PDT in GELP in women.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
clobetasol propionate 0,05% ointment
Drugcontinuously daily treatment for 6 weeks
Other names: Dermovate 0.05% ointment
hexaminolevulinate
Drugone PDT treatment
Primary outcomes
-
Percentage change of GELP score and/or VAS score 6 weeks after start of treatment.
Time frame: 6 weeks
Secondary outcomes
-
Percentage change of GELP score and/or VAS score 6 months after start of treatment.
Time frame: 6 months
Sponsors and collaborators
Lead sponsor
Oslo University Hospital
Other
Collaborators
- Photocure
Registry information
Official study 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)
Important dates
- Study start
- 2011
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Jan 25, 2011
- Registry last updated
- Mar 17, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.