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

5-AMINOLEVULINIC ACID PHOTODYNAMIC THERAPY FOR THE TREATMENT OF PREMALIGNANT DISORDERS OF THE VULVA - ALA-PDT for premalignant vulvar disorders

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47821

Enrollment

180

Registered

2011-11-24

Start date

2013-06-07

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

VLS patients will be randomized to receive 20% ALA gel or Clobetasol Propionaat 0,05% ointment. HSIL patients will be randomized to receive 20% ALA gel or 5% imiquimod cream. Patients receiving ALA-

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Secondary

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

Primary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)