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Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia (PITVIN)

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ClinicalTrials.gov Identifier: NCT01861535
Recruitment Status : Active, not recruiting
First Posted : May 23, 2013
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
Austrian Science Fund (FWF)
Information provided by (Responsible Party):
Medical University of Graz

Tracking Information
First Submitted Date  ICMJE May 6, 2013
First Posted Date  ICMJE May 23, 2013
Last Update Posted Date January 13, 2020
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2013)
Complete clinical response [ Time Frame: 6 months ]
No clinical evidence of vulvar lesion, i.e. 100% reduction of primary lesion size
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01861535 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2013)
  • Clinical response/ lesion size [ Time Frame: 6 months ]
    Vulvar lesions will be described, measured with calipers, mapped and photographed. The digital photos will be analyzed with a computer program (ImageJ) to calculate the total lesion size in cm². Results will be classified as: no response (NR, reduction in lesion size of 25% or less), weak partial response (wPR, 26-75% reduction), strong partial response (stPR, 76%-99% reduction) and Complete response (CR, 100% reduction).
  • Histologic response [ Time Frame: 6 months ]
    At baseline punch biopsies will be taken from the affected areas. The site of the initial biopsy will be photodocumented to ensure that the follow-up biopsy at 6 months is taken from the same site. Histologic results will be classified as response (R): complete disappearance of usual type VIN or reduction to VIN1,or no response (NR). All biopsy samples will be analysed independently by two experienced gynecologic pathologists unaware of the treatment allocation
  • Extent of surgery [ Time Frame: 6 months ]
    The number, types and extent of surgical procedures will be recorded. The extent of surgery will be recorded as total operated lesion size (in cm², as measured on pre-operative photograph) and relative operated lesion size (percentage of operated lesion size compared with the original pretreatment lesion size)
  • HPV status [ Time Frame: 6 months ]
    HPV status will be measured with the qualitative cobas® HPV Test, Roche, and the the APTIMA ® HPV assay, Gen-Probe.
  • Clinical response/lesion size [ Time Frame: 12 months ]
    Vulvar lesions will be described, measured with calipers, mapped and photographed. The digital photos will be analyzed with a computer program (ImageJ) to calculate the total lesion size in cm². Results will be classified as: no response (NR, reduction in lesion size of 25% or less), weak partial response (wPR, 26-75% reduction), strong partial response (stPR, 76%-99% reduction) and Complete response (CR, 100% reduction).
  • Extent of surgery [ Time Frame: 12 months ]
    The number, types and extent of surgical procedures will be recorded. The extent of surgery will be recorded as total operated lesion size (in cm², as measured on pre-operative photograph) and relative operated lesion size (percentage of operated lesion size compared with the original pretreatment lesion size)
  • HPV status [ Time Frame: 12 months ]
    HPV status will be measured with the qualitative cobas® HPV Test, Roche, and the the APTIMA ® HPV assay, Gen-Probe.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 21, 2013)
  • "Cervical Dysplasia Distress" Questionnaire [ Time Frame: 6 months ]
    Change from baseline in "Cervical Dysplasia Distress" score at 6 months
  • "Cervical Dysplasia Distress" questionnaire [ Time Frame: 12 months ]
    Change from Baseline in "Cervical Dysplasia Distress" score at 12 months
  • "Fear of Progression" Questionnaire [ Time Frame: 6 months ]
    Change from Baseline "Fear of Progression" score at 6 months.
  • "Fear of Progression" questionnaire [ Time Frame: 12 months ]
    Change from Baseline "Fear of Progression" score at 12 months.
  • "Sexual activity" Questionnaire [ Time Frame: 6 months ]
    Change from baseline "Sexual activity" score at 6 months
  • "Sexual activity" questionnaire [ Time Frame: 12 months ]
    Change from baseline "Sexual activity" score at 12 months
  • Immune cells in the epidermis [ Time Frame: 6 months ]
    Histochemical analysis of immune cells from vulvar biopsy samples will be performed at baseline and at 6 months. Frozen sections will be prepared and stained with corresponding cell markers. Immune cell populations will be quantified as number of cells per square millimetre and will be compared between the two treatment groups. The following markers and their primary antibodies will be analysed: CD1a, marker for Langerhans cells, CD94, marker for natural killer cells, CD4, marker for T-helper cells, CD8, marker for cytotoxic T-cells and CD207, marker for immature dendritic cells expressing Langerin.
  • Aesthetic results [ Time Frame: 6 months ]
    Detailed photos of the overall vulva will be taken. Photos will be compared to photos taken at baseline and judged by 4 independent, blinded observers for aesthetic results.
  • Aesthetic results [ Time Frame: 12 months ]
    Detailed photos of the overall vulva will be taken. Photos will be compared to photos at baseline and judged by 4 independent, blinded observers for aesthetic results.
  • Visual analogue scale (VAS) for assessment of pain and pruritus [ Time Frame: 6 months ]
    Change of VAS score for pain and pruritus from baseline to 6 months. VAS will be assessed at baseline, 1,2 ,3,4,5 and 6 months.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
Official Title  ICMJE Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
Brief Summary To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs. standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vulvar Intraepithelial Neoplasia
Intervention  ICMJE
  • Drug: Imiquimod
    Other Name: Aldara
  • Procedure: Surgery
    Other Names:
    • Excision
    • Ablation
Study Arms  ICMJE
  • Experimental: Primary Imiquimod
    Treatment with imiquimod will be patient self-administered for a period of 4 months with possible extension to 6 months. A thin layer of imiquimod cream should be applied to the lesion and remain overnight without a cover. Application will be once a week for 2 weeks, then twice a week the following 2 weeks and, if tolerated, 3 times a week for the last weeks. In case of severe side-effects the number of applications can be reduced; a treatment-free period of no more than 1 week is permitted
    Intervention: Drug: Imiquimod
  • Active Comparator: Primary surgery
    The type of surgery (excision or ablation) will be based on clinical findings and surgeon`s judgement. After excision the specimen will be histologically analyzed to assess resection margins and rule out invasion.
    Intervention: Procedure: Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 21, 2013)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed VIN (only usual type, formerly VIN 2-3)
  • Visible, measurable lesion(s)
  • Contraception (for premenopausal women)

Exclusion Criteria:

  • Evidence of invasion
  • History of cancer or severe inflammatory dermatosis of the vulva
  • Pregnancy, lactation
  • Immunodeficiency
  • Any treatment for VIN within the previous three months
  • Known hypersensitivity to imiquimod
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01861535
Other Study ID Numbers  ICMJE KLI293
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of Graz
Study Sponsor  ICMJE Medical University of Graz
Collaborators  ICMJE Austrian Science Fund (FWF)
Investigators  ICMJE
Principal Investigator: Gerda Trutnovsky, MD Medical University of Graz
Study Director: Karl Tamussino, MD Medical University of Graz
PRS Account Medical University of Graz
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP