A phase 2, randomized, vehicle-controlled, double-blind study to explore the efficacy, pharmacodynamics and safety of topical ionic contra-viral therapy (ICVT) comprised of digoxin and furosemide in HPV-induced genital lesions of immunocompromised and immunocompetent patients.

Cutanea Life Sciences0 sites48 target enrollmentAugust 9, 2017

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Cutanea Life Sciences
Enrollment: 48
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 9, 2017

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Cutanea Life Sciences

Eligibility Criteria

Inclusion Criteria

•For enrollment of subjects the following criteria must be met:
•1\. Vulvar HSIL or AGW patients, \= 18 years of age, in general, stable good health (with the exception of the immunocompromised disorder) as per judgment of the investigator based upon the results of a medical history, physical examination, ECG, chemistry, hematology.
•2\. In case of the immunocompromised patient group(s): having an immunosuppressive disease or receiving immunosuppressive therapy for any reason including but not limited to; patients with auto\-immune disease, HIV patients, transplantation patients
•3\. In case of the genital warts patient group(s): have at least 3 genital warts (only applicable for study part 1\).
•4\. In case of vulvar HSIL patient group: at least one lesion that can be accurately measured (using RECIST criteria) in at least one dimension with longest diameter \=20 mm OR in 2 perpendicular dimensions that when multiplied together give a surface area \=120 mm² (only applicable for study part 1\).
•5\. If female of childbearing potential, have a negative urine pregnancy test at Screening and Day 0, and is willing to use effective contraception during the study and 3 months afterwards (i.e. oral, implanted, injectable, IUD, diaphragm, condom, tubal ligation, abstinence, or are in a monogamous relationship with a partner who has had a vasectomy)
•6\. Able to participate and willing to give written informed consent and to comply with the study restrictions
•7\. Ability to communicate well with the investigator in the Dutch language
•8\. Willing to refrain from using other topical products in the treatment area, or prohibited medications for the duration of the study
•Are the trial subjects under 18? no

Exclusion Criteria

•Eligible subjects must meet none of the following 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\.Have used or received any topical genital wart treatment, cryotherapy, electrocoagulation, surgery in the treatment area within 28 days prior to enrolment
•3\.Have used or received any topical vulvar HSIL treatment, laser therapy or surgery in the treatment area within 28 days prior to enrolment
•4\.Have any current pathologically relevant skin infections in the treatment area other than genital warts (such as atopic dermatitis, lichen sclerosis, lichen planus or psoriasis)
•5\.Have a known sensitivity to any of the investigational product ingredients, including digoxin and furosemide
•6\.Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year
•7\.Loss or donation of blood over 500 mL within three months prior to screening.