Status:
TERMINATED
ICVT in HPV-induced Genital Lesions of Immunocompromised and Immunocompetent Patients
Lead Sponsor:
Maruho Co., Ltd.
Conditions:
HPV-Induced Genital Lesions
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is intended to explore and evaluate the pharmacodynamics and clinical efficacy of the ionic contra-viral therapy CLS003 in immunocompromised and immunocompetent patients with benign and pre...
Detailed Description
This study is intended to explore clinical efficacy and safety/tolerability of ICVT as a potential treatment for benign and premalignant HPV-induced genital lesions in immunocompetent and immunosuppre...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years 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.
- In case of immunocompromised patients including but not limited to; patients receiving immunosuppressive therapy for any reason, patients with auto-immune disease, HIV patients, transplantation patients
- In case of genital warts patient group(s): have at least 3 genital warts (only applicable to Study Part 1)
- In case of vulvar HSIL: at least one lesion that can be accurately measured 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 to Study Part 1)
- 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)
- Able to participate and willing to give written informed consent and to comply with the study restrictions
- Ability to communicate well with the investigator in the Dutch language
- Willing to refrain from using other topical products in the treatment area, or prohibited medications for the duration of the study
Exclusion
- 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
- Have used or received any topical genital wart treatment, cryotherapy, electrocoagulation, surgery in the treatment area within 28 days prior to enrolment
- Have used or received any topical vulvar HSIL treatment, laser therapy or surgery in the treatment area within 28 days prior to enrolment
- Have any current relevant skin infections in the treatment area other than genital warts (inclusively, but not limited to atopic dermatitis, lichen sclerosis, lichen planus or psoriasis)
- Have a known sensitivity to any of the investigational product ingredients, including digoxin and furosemide
- Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year
- Loss or donation of blood over 500 mL within three months prior to screening.
Key Trial Info
Start Date :
October 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2018
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03334240
Start Date
October 5 2017
End Date
October 30 2018
Last Update
March 20 2019
Active Locations (1)
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1
LUMC/Centre For Human Drug Research
Leiden, Netherlands