NCT01282515

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

3.2 years

First QC Date

January 24, 2011

Last Update Submit

March 14, 2021

Conditions

Genital Lichen Planus

Outcome Measures

Primary Outcomes (1)

  • Percentage change of GELP score and/or VAS score 6 weeks after start of treatment.

    6 weeks

Secondary Outcomes (1)

  • Percentage change of GELP score and/or VAS score 6 months after start of treatment.

    6 months

Study Arms (2)

ELP active

EXPERIMENTAL

one PDT treatment with 2 ml hexaminolevulinate 6 mg/ml gel

Drug: hexaminolevulinate

topical steroids

ACTIVE COMPARATOR

treatment with clobetasol propionate 0.05% ointment used daily for 6 weeks

Drug: clobetasol propionate 0,05% ointment

Interventions

clobetasol propionate 0,05% ointmentDRUG

continuously daily treatment for 6 weeks

Also known as: Dermovate 0.05% ointment
topical steroids
hexaminolevulinateDRUG

one PDT treatment

ELP active

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet, OsloUniversity hospital

Oslo, 0027, Norway

Location

MeSH Terms

Interventions

ClobetasolOintments5-aminolevulinic acid hexyl ester

Intervention Hierarchy (Ancestors)

BetamethasoneSteroids, FluorinatedSteroidsFused-Ring CompoundsPolycyclic CompoundsDosage FormsPharmaceutical Preparations

Study Officials

  • anne lise helgesen, md

    research fellow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant dermatologist

Study Record Dates

First Submitted

January 24, 2011

First Posted

January 25, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

NO(1)