ALA-PDT for premalignant vulvar disorders.

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2011-003134-13-NL
• Date of registration: 28/11/2011
• Prospective Registration: Yes
• Primary sponsor: Erasmus MC
• Public title: ALA-PDT for premalignant vulvar disorders.
• Scientific title: 5-Aminolevulinic Acid PhotoDynamic Therapy for the treatment of premalignant disorders of the vulva. - ALA-PDT for premalignant vulvar disorders
• Date of first enrolment: 13/02/2012
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003134-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 4

Countries of recruitment

Netherlands

Contacts

• Name: Dr. ir. L.J. Blok
• Affiliation: Erasmus MC

• Name: Dr. ir. L.J. Blok
• Affiliation: Erasmus MC

Key inclusion & exclusion 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:
- (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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

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)

Intervention(s)

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 applicable
Concentration unit: % percent
Concentration type: equal
Concentration number: 20-

Trade Name: Aldara (Imiquimod)
Product Name: Aldara 5% cream (Imiquimod)
Pharmaceutical Form: Cream
INN or Proposed INN: IMIQUIMOD
CAS Number: 99011-02-6
Current Sponsor code: not applicable
Concentration unit: % percent
Concentration type: equal
Concentration number: 5-

Trade Name: Dermovate cream 0,5 mg/g
Product Name: Dermovate
Pharmaceutical Form: Cream
INN or Proposed INN: CLOBETASOL PROPIONATE
CAS Number: 25122-46-7
Current Sponsor code: not applicable
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.05-

Primary Outcome(s)

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.

Timepoint(s) of evaluation of this end point: Leeen s.v.p. invullen!

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.

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 Outcome(s)

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.

Secondary ID(s)

A551109

Unit TRC Dept. Urology Erasmus MC

Source(s) of Monetary Support

Erasmus MC