Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia

Vulvar Intraepithelial Neoplasia Clinical Trial

— PITVIN  

Official title:

Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861535
• Other study ID #: KLI293
• Status: Completed
• Phase: Phase 3
• Start date: June 2013
• Est. completion date: February 2021

Study information

• Verified date: April 2021
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs. standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma in Situ
• Neoplasms
• Vulvar Intraepithelial Neoplasia

Intervention

Drug:
• Imiquimod

Procedure:
• Surgery

Locations

Country	Name	City	State
Austria	Dep. of Gynecology, Krankenhaus Barmherzige Brüder Graz	Graz	Styria
Austria	Department of Obstetrics and Gynecology/ Medical University of Graz	Graz
Austria	Department of Gynecology and Obstetrics, Medical University of Innsbruck	Innsbruck
Austria	Dep. of Gynecology and Obstetrics, Klinikum Klagenfurt	Klagenfurt
Austria	Dep. of Gynecology and Obstetrics	Leoben
Austria	Dep. of Gynecology and Obstetrics, Landes Frauen- und Kinderklinik Linz	Linz	Oberösterreich
Austria	Dep. of Gynecology, Krankenhaus Barmherzige Schwestern Linz	Linz
Austria	Dep. of Gynecology and Obstetrics, Landeskrankenhaus Salzburg	Salzburg
Austria	Department of General Gynecology and Gynecology Oncology, Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	Austrian Science Fund (FWF)

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	"Cervical Dysplasia Distress" Questionnaire	Change from baseline in "Cervical Dysplasia Distress" score at 6 months	6 months
Other	"Cervical Dysplasia Distress" questionnaire	Change from Baseline in "Cervical Dysplasia Distress" score at 12 months	12 months
Other	"Fear of Progression" Questionnaire	Change from Baseline "Fear of Progression" score at 6 months.	6 months
Other	"Fear of Progression" questionnaire	Change from Baseline "Fear of Progression" score at 12 months.	12 months
Other	"Sexual activity" Questionnaire	Change from baseline "Sexual activity" score at 6 months	6 months
Other	"Sexual activity" questionnaire	Change from baseline "Sexual activity" score at 12 months	12 months
Other	Immune cells in the epidermis	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.	6 months
Other	Aesthetic results	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.	6 months
Other	Aesthetic results	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.	12 months
Other	Visual analogue scale (VAS) for assessment of pain and pruritus	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.	6 months
Primary	Complete clinical response	No clinical evidence of vulvar lesion, i.e. 100% reduction of primary lesion size	6 months
Secondary	Clinical response/ lesion size	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).	6 months
Secondary	Histologic response	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	6 months
Secondary	Extent of surgery	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)	6 months
Secondary	HPV status	HPV status will be measured with the qualitative cobas® HPV Test, Roche, and the the APTIMA ® HPV assay, Gen-Probe.	6 months
Secondary	Clinical response/lesion size	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).	12 months
Secondary	Extent of surgery	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)	12 months
Secondary	HPV status	HPV status will be measured with the qualitative cobas® HPV Test, Roche, and the the APTIMA ® HPV assay, Gen-Probe.	12 months