5-AMINOLEVULINIC ACID PHOTODYNAMIC THERAPY FOR THE TREATMENT OF PREMALIGNANT DISORDERS OF THE VULVA

Phase 2

Completed

Conditions: high grade squamous intraepithelial lesion (HSIL) and vulvar lichen sclerosus (VLS): premalignant vulvar disorders
10040900
10047789

Registration Number: NL-OMON47821

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

- Histologically proven HSIL, without invasion or clinically proven VLS
- The patient is willing to use a medically acceptable method of contraception throughout the study.
- Age 18 and above

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 ointment formulations
- History of psoriasis or other inflammatory dermatosis of the vulva
- Insufficient understanding of the Dutch language

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>VLS:<br /><br>- Clinical response to the treatment by performing physical examination,<br /><br>monitoring relieve of symptoms like itching and disorder-related pain, taking<br /><br>high resolution photographs.<br /><br>- Histological regression to normal vulvar tissue using a histologic scoring<br /><br>system.<br /><br>- Improvement of quality of life 4 and 24 weeks after treatment<br /><br><br /><br>HSIL:<br /><br>- Clinical response to the treatment by monitoring reduction of laesion size,<br /><br>relieve of symptoms like itching and disorder-related pain, taking high<br /><br>resolution photographs.<br /><br>- Histological regression to normal vulvar tissue using a histologic scoring<br /><br>system.<br /><br>- Improvement of quality of life 4 and 24 weeks after treatment<br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>VLS:<br /><br>- Treatment induced pain (ALA PDT group)<br /><br><br /><br>HSIL<br /><br>- Treatment induced pain (ALA-PDT group)<br /><br>- Normalization of immunocompetent cells numbers in the region of the disorder<br /><br>at 4 weeks after the end of treatment<br /><br>- Clearance of HPV DNA in HSIL lesions at 4 weeks after treatment<br /><br>- Normalization of expression levels of Ki67, p16, CD31, CD34 and p53 and<br /><br>mir-155 at at 4 weeks after treatment</p><br>