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

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)

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01282515

Enrollment

Registered

2011-01-25

Start date

2011-08-31

Completion date

2014-10-31

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genital Lichen Planus

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.

Interventions

DRUGclobetasol propionate 0,05% ointment

continuously daily treatment for 6 weeks

DRUGhexaminolevulinate

one PDT treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026