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Vulval intraepithelial neoplasia: immune responses to human papillpmavirus. - HPV immunology in VIN

Vulval intraepithelial neoplasia: immune responses to human papillpmavirus. - HPV immunology in VIN

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-006761-32-GB
Enrollment
Unknown
Registered
2008-02-15
Start date
2008-04-15
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Vulval intraepithelial neoplasia MedDRA version: 9.1 Level: LLT Classification code 10056574 Term: Vulval intraepithelial neoplasia

Interventions

Trade Name: Aldara 5% cream Pharmaceutical Form: Cream INN or Proposed INN: imiquimod CAS Number: 99011-02-6 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration n

Sponsors

Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Pilot: Age over 18 Able to give fully informed consent Study: Female Age 18-60 Able to give fully informed consent Diagnosis of vulval intraepithelial neoplasia (VIN) Or Diagnosis of inflammatory vulval dermatosis Or Diagnosis of genital warts Or Normal vulval skin Have no known allergy to imiquimod (only patients with VIN for treatment with imiquimod) 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Study: Male Individuals unable for any reason to give fully informed consent Age below 18 or over 60 years of age Immunosuppression Pregnancy (only patients with VIN for treatment with imiquimod) Breastfeeding (only patients with VIN for treatment with imiquimod) Previous vulval carcinoma (only patients with VIN for treatment with imiquimod) Known allergy to imiquimod (only patients with VIN for treatment with imiquimod)

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the local and systemic immune responses to human papillomavirus during treatment of vulval intraepithelial neoplasia.;Secondary Objective: To investigate whether local and systemic immune responses to human papillomavirus in vulval intraepithelial neoplasia are distinct from those in inflammatory vulval disease, genital warts and normal subjects.;Primary end point(s): For control subjects - Collection and analysis of samples taken at single time point For patients with VIN - Collection and analysis of samples taken after treatment and clinical follow-up for one year.—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026