ALA-PDT for premalignant vulvar disorders.

• Conditions: Premalignant vulvar disorders (usual type Vulvar Intraepithelial Neoplasia); MedDRA version: 14.0Level: PTClassification code 10062135Term: Vulval neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-003134-13-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

- Histologically proven usual type VIN, without invasion or histologically proven LS.
- The patient is willing to use a medically acceptable method of contraception throughout the study.
- Age 18 and above.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

- (Micro-)invasive carcinoma.
- Pregnancy and/or breastfeeding.
- Past history of vulvar cancer.
- Differentiated (non HPV-related) VIN.
- Other treatment of VIN, anogenital warts or LS within 1 month of start treatment.
- Hypersensitivity to any components of the cream formulations.
- History of psoriasis or other inflammatory dermatosis of the vulva.
- Insufficient understanding of the Dutch language.

Study & Design

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