Cutaneous warts warts
Conditions
Interventions
o CyPep-1 topical formulation 1% (w/w)
o Vehicle topical formulation (placebo)
Sponsors
Cytovation AS
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive. (Healthy status is defined by absence of evidence of any clinical significant/uncontrolled active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs,12-lead ECG, haematology, blood chemistry, and urinalysis); 2. Body mass index (BMI) between 18 and 35 kg/m2, inclusive; 3. Free of clinically significant systemic or dermatologic disorders, which, in the opinion of the investigator, will interfere with the study results or increase the risk of Adverse Events; 4. Have at least 1 (non- peri / subungual) common wart on the, preferably, dorsal side of the hand /fingers which is 3-10 mm (inclusive) in diameter in its longest dimension on the plane of the skin; 5. If female of childbearing potential, have a negative urine pregnancy test at Screening/Day 0, and is willing to use effective contraception during the study (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 cosmetics or other topical products in the treatment area for the duration of the study; 9. Agree not to use wart-removing products (prescription or over-the-counter) in the target area or prohibited medications other than the study medication during the course of the study.
Exclusion criteria
Exclusion criteria: Eligible subjects must meet none of the following exclusion criteria: 1. Any clinically significant abnormality as determined by medical history taking and physical examinations obtained during the screening visit that in the opinion of the investigator would interfere with the study objectives or compromise subject safety; 2. Not willing to use effective (double barrier) contraception until at least 3 months after last study drug application; 3. For women: a positive pregnancy test and/or breastfeeding at screening or women who plan to become pregnant; 4. A positive test for drugs of abuse at screening; 5. History of alcohol or illicit drug abuse (alcohol abuse defined as alcohol consumption > 21 units/week); 6. Positive test results for Hepatitis B, Hepatitis C or HIV; 7. Have used salicylic acid or any other over-the-counter wart-removing product including cryo-therapy in the treatment area within 28 days prior to first study drug application; 8. Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 60 days prior to first study drug application or during the course of the study. Routine use of inhaled or intranasal corticosteroids during the study is allowed; 9. Have any current and / or recurrent clinical significant skin infection in the treatment area other than common warts; 10. Have a known sensitivity to any of the investigational product ingredients; 11. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year; 12. Donation of blood or blood loss of >500 mL within 3 months prior to screening or donation of plasma within 14 days 13. Not having a general practitioner; 14. Not willing to give permission to have the general practitioner to be notified upon participation in this study; 15. Any condition that in the opinion of the investigator would complicate or compromise the study or the well-being of the subject.;Part 2 only: 16. Have treatment resistant / persistent warts as defined as one of the following: a. More than 5 different failed treatments including topical formulations and cryotherapy b. Longer than 6 years presence of the target wart c. Having received active treatment in a clinical trial with an experimental drug for cutaneous warts.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamic / efficacy endpoints Pharmacodynamic effects of CyPep-1 will be assessed at the time points indicated in the Visit and Assessment Schedule (Table 1) by o Changes in morphology on-site; o Change in total wart count; o HPV viral load assessment of target lesions by quantitative PCR including HPV genotyping in swabs and biopsies; o Absolute reduction in wart size (diameter and volume) at Week 4 as compared to baseline, measured by calliper and 3D photography; o Absolute reduction in wart size (diameter and volume) at follow-up (week 10 and 16) as compared to baseline, measured by calliper and 3D photography; o Change in the HPV viral load (nominal, natural log transformed, and natural log of viral load per DNA copies) as determined by qPCR at Weeks 1, 2,3,4, 10 and 16 as compared to baseline o Mean HPV viral load (nominal, natural log transformed, and natural log of viral load per DNA copies) at treatment weeks and overall o Percent reduction and clearance of warts o If considered applicable, cellular and immune response in biopsies (inlcuding H&E, HPV E4, Ki67) Pharmacokinetic endpoints Following PK samples will be analyzed: Part 2: Day 28 (EOT) to determine if there is systemic exposure to CyPep-1. Tolerability / safety endpoints Adverse events (AE) will be collected throughout the study, at every study visit. Vital signs and ECGs will performed at several timepoints as represented in the Visit and Assessment schedules (table 1). | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory endpoints o Changes in morphology o Changes in morphology by optical coherence tomography | — |
Countries
Netherlands
Outcome results
None listed