Premalignant vulvar disorders (usual type Vulvar Intraepithelial Neoplasia) MedDRA version: 14.0 Level: PT Classification code 10062135 Term: Vulval neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 5-Aminolevulinic Acid
Product Code: Not applicable
Pharmaceutical Form: Gel
INN or Proposed INN: 5-aminolevulinic acid hydrochloride
CAS Number: 5451-09-2
Current Sponsor code: not appli
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of low dose rate light fractionated aminolevulinic acid-Photodynamic Therapy (ALA-PDT) for treatment of usual type Vulvar Intraepithelial Neoplasia (uVIN) and lichen sclerosus (LS). ;Secondary Objective: To determine clearance of HPV after treatment of uVIN; to assess normalization immunocompetent cell counts and of expression of a number of markers (Ki67, p16, p53, mir-155) after treatment; to monitor pain during and after treatment; to monitor quality of life before and after treatment. ;Primary end point(s): Clinical response to the treatment in VIN or LS lesions after the end of ALA-PDT treatment measured by 1) reduction in lesion size after the end of treatment as visualized with high resolution photographs, 2) histological regression of uVIN or LS to ‘normal’ vulvar tissue as visualized in H/E stained sections and 3) relieve of symptoms like itching and disorder-related pain. ;Timepoint(s) of evaluation of this end point: Leeen s.v.p. invullen! | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Normalization of immunocompetent cells numbers in the region of the disorder at 4 weeks after the end of treatment; clearance of HPV DNA in uVIN lesions at 4 weeks after treatment; normalization of expression levels of Ki67, p16 and p53 at 4 weeks after treatment; normalization of expression level of mir-155 at at 4 weeks after treatment; improvement of quality of life at 4 weeks after treatment; and assessment of treatment-induced pain.;Timepoint(s) of evaluation of this end point: 4 weeks after treatment. | — |
Countries
Netherlands
Contacts
Public ContactDr. ir. L.J. Blok
Erasmus MC
Outcome results
None listed