A two-part (observational and intervention) study to explore disease characteristics of vulvar (pre)malignancies compared to healthy volunteers.

CHDR0 sites40 target enrollmentTBD

Conditionsvulvar (pre)malignancies

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: vulvar (pre)malignancies
Sponsor: CHDR
Enrollment: 40
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

.A.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Investigators

Sponsor

CHDR

Eligibility Criteria

Inclusion Criteria

•1\. Non\-pregnant female subjects, 25\-75 years of age (inclusive); in general, stable good health as per judgment of the investigator based upon the results of a medical history, physical examination (BMI \= 30\) and vital signs.
•2\. BMI of \= 30
•3\. If female of childbearing potential, have a negative urine pregnancy test at Day 0\.
•4\. Willing to give written informed consent and willing and able to comply with the study protocol.
•5\. Ability to communicate well with the investigator in the Dutch or English language.
•6\. Subject is willing to undergo vulvar biopsies.
•7\. Subject is willing to refrain from washing (including bathing, swimming, showering and excessive sweating) the vulva counting from midnight of every study visit day.
•8\. Subject is willing to refrain from application of products (e.g. ointments, crème or wash) on the vulva 24 hours prior to every study visit day.
•9\. Subject is willing to refrain from sexual intercourse less than 24 hours prior to every study visit.
•10\. Subject is willing to refrain from shaving, waxing or other hair removing treatments in the perineal area in the

Exclusion Criteria

•1\. Significant, uncontrolled or unstable disease in any organ system as per judgment of the investigator (regardless of association with the immunosuppressing disorder/therapy), including but not limited to: psychiatric, neurologic, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, endocrine, hematologic or respiratory disease.
•2\. History of immunological abnormality (e.g., immune suppression) that may interfere with study objectives, in the opinion of the investigator.
•3\. Known infection requiring (topical or oral) antibiotic therapy within 28 days prior to Day 0;
•4\. The use of any oral/systemic medication (e.g. immunomodulatory, immunosuppressive, acetylsalicylic acid) within 28 days prior to Day 0, if the investigator judges that it may interfere with the study objectives. The use of paracetamol (up to 4 g/day) is allowed;
•5\. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;
•6\. Self\-reported: (a) immunocompromised state, (b) sexually transmitted disease, (c) AIDS and/or (d) hepatitis.
•7\. Have any current and / or recurrent clinically significant or subject reported skin condition in the vulvar area other than the (absence of) vulvar disease wherefore subject is included in the study.
•Eligible vulvar patients must meet none of the following exclusion criteria at screening:
•8\. Have any current relevant (inflammatory) skin infections in the treatment area other than the observational disease (vulvar LS, vulvar HSIL of VSCC), inclusively, but not limited to atopic dermatitis, herpes, candidiasis or psoriasis.
•9\. Have used or received any topical vulvar HSIL treatment, laser therapy or surgery in the anogenital area within 28 days prior to Day 0