A study to assess the effect and safety/tolerability of a locally applied gel in patients with usual type vulvar intraepithelial neoplasia

Phase 1

• Conditions: Patients with usual type vulvar intraepithelial neoplasia; MedDRA version: 18.0Level: PTClassification code 10054932Term: Vulvar dysplasiaSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-002724-16-NL
• Lead Sponsor: Cutanea Life Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-28
• Last Update Posted: 4 September 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1.Women = 18 years
2.Biopsy proven uVIN, biopsies to have been taken within the last three months
3.Written informed consent to participate in the trial
4.At least one lesion that can be accurately measured (using RECIST criteria)
-in at least one dimension with longest diameter = 20mm
-OR in two perpendicular dimensions that when multiplied together give a surface area of greater than 120mm2 (e.g. 15mm x 8mm or 12mm x 10mm)
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 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Has any concomitant disease or significant medical conditions that would, in the opinion of the Investigator, potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical trial.
2.Clinically significant abnormalities, as judged by the Investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis) or ECG. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
3.Indication of a current active infectious disease of the vulva, other than HPV
4.Pregnant, breast feeding or trying to conceive
5.Active treatment for uVIN within the previous eight weeks
6.Patients receiving immunosuppressive therapy
7.HIV positive or transplant patients
8.Any condition that in the opinion of the investigator could interfere with the conduct of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified