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

• Conditions: lichen sclerosusgenital dysplasia; MedDRA version: 12.0Level: LLTClassification code 10024434Term: Lichen sclerosus; MedDRA version: 12.0Level: LLTClassification code 10051999Term: Anogenital dysplasia

• Registration Number: EUCTR2009-015640-42-BE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-04
• Last Update Posted: 14 October 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>evaluation of the tolerance