Etude de l’efficacité thérapeutique de la photothérapie dynamique (PDT) dans le lichen scléreux génital et les dysplasies génitales résistantes aux traitements conventionnels.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015640-42-BE

Enrollment

Registered

2009-09-04

Start date

2009-09-29

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

lichen sclerosus genital dysplasia MedDRA version: 12.0 Level: LLT Classification code 10024434 Term: Lichen sclerosus MedDRA version: 12.0 Level: LLT Classification code 10051999 Term: Anogenital dysplasia

Interventions

Trade Name: dynamic phototherapy with methyl aminolevulinate Product Name: metvix Product Code: PL10590/0048 Pharmaceutical Form: Cream

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient > 18 years Unresponsive lichen sclerosus to topical steroids and/or unresponsive vulvar dysplasia (VIN) to Imiquimod treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy Immunocompromized patients history of contact allergy to cetostearyl alcohol or methyl- propylparahydroxybenzoate (E218, E216).

Design outcomes

Primary

Measure	Time frame
Main Objective: evaluation of the efficacy and tolerability of the photodynamic therapy on lichen sclerosus and/or the anogenital dysplasia.;Secondary Objective: none;Primary end point(s): evaluation of the efficacy evaluation of the tolerance	—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026