Treatment of Female Genital Erosive Lichen Planus(GELP) W... | NCT01282515

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

NCT01282515

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Mar 17, 2021Actual

Enrollment

40Actual

Phase

Phase 2Phase 3

Conditions

Genital Lichen Planus

Interventions

clobetasol propionate 0,05% ointment
hexaminolevulinate

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Jan 24, 2011

First Submission Date that Met QC Criteria

Jan 24, 2011

First Posted Date

Jan 25, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2021

Last Update Posted Date

Mar 17, 2021Actual

Name	Class
Photocure	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
clobetasol propionate 0,05% ointment	Drug	continuously daily treatment for 6 weeks	topical steroids

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage change of GELP score and/or VAS score 6 weeks after start of treatment.		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage change of GELP score and/or VAS score 6 months after start of treatment.		6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
anne lise helgesen, md	research fellow	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rikshospitalet, OsloUniversity hospital		Oslo		0027	Norway

Intervention Browse Module

MeSH Terms

ID	Term
D002990	Clobetasol
D009824	Ointments
C419924	5-aminolevulinic acid hexyl ester

Ancestor Terms

ID	Term
D001623	Betamethasone
D013259	Steroids, Fluorinated
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided