Cutaneous warts MedDRA version: 16.1 Level: HLT Classification code 10033724 Term: Papilloma viral infections System Organ Class: 100000004862
Conditions
Sponsors
Cutanea Life Sciences
Eligibility
Sex/Gender
All
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 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 30 kg/m2, inclusive; 3. Fitzpatrick skin type I-II-III-IV; 4. At least 4 cutaneous warts on the hands, separated by at least 1 cm of skin; 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
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. For women: a positive pregnancy test and/or nursing at screening; 3. A positive test for drugs of abuse at screening; 4. Have used salicylic acid or any other over-the-counter wart-removing product in the treatment area within 30 days prior to enrolment; 5. Have received cryotherapy in the treatment area within 60 days prior to enrolment; 6. Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 30 days prior to enrolment or during the course of the study. Routine use of inhaled or intranasal corticosteroids during the study is allowed; 7. Subjects currently using systemic digoxin or furosemide or any of the following prohibited medications (Note: exceptions will only be made if the rationale is discussed and clearly documented between the investigator and the sponsor): Potential drug interactions with furosemide: Aminoglycoside antibiotics Ethacrynic acid Salicylates Cisplatin Tubocurarine Suyccinlycholine Lithium ACE inhibitors Chloral hydrate Phenytoin Methotrexate Cephalosporins Cyclosporine Potential drug interactions with digoxin: Potassium-depleting diuretics Quinidine Verapamil Amiodarone Propafenone Indomethacin Intraconazole Alprazolam Spironolactone Beta-adrenergic blocking agents Calcium channel blockers 8. Have any current and / or recurrent pathologically relevant skin infections in the treatment area other than common warts (with the exception of herpes simplex virus labialis); 9. Have any current uncontrolled infection; 10. Atopic dermatitis or any other skin diseases involving chronic inflammation or reducing the skin barrier function; 11. Have a known sensitivity to any of the investigational product ingredients, including digoxin and furosemide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the systemic exposure of digoxin and furosemide after repeated topical CLS003 application in otherwise healthy subjects with multiple cutaneous warts; • To assess the safety/tolerability profile of CLS003. ;Secondary Objective: • To explore the pharmacodynamic effects of topically applied CLS003 on wart morphology and HPV viral load; • To apply HPV viral load quantitative PCR (qPCR) on relevant clinical material as preparation for subsequent studies. ;Primary end point(s): Tolerability / safety endpoints Adverse events (AE) will be collected throughout the study, at every study visit. Laboratory safety testing, 12-Lead ECGs and vital signs will be performed and measured multiple times during the course the study according to the Visit and Assessment Schedule. Pharmacokinetic endpoints Samples for pharmacokinetic determination of plasma digoxin and furosemide concentrations will be collected according to the Visit and Assessment Schedule (Table 1). Samples will be tested by validated HPLC/MS/MS with a lower limit of quantification (LLOQ) of 0.05 ng/mL. ;Timepoint(s) of evaluation of this end point: -Pharmacokinetics: Blood samples collected at day 1 (pre-dose, 6h, 12h), day 2, day 3, day 4, day 5, day 6, day 7 (pre-dose, 6h, 12h), day 8, day 9, day 11 and day 14. - AEs: continuous from screening until final study evaluation (day 14). - Blood samples for clinical laboratory tests will be obtained at screening, pre-dose on day 1, day 2, day 4, day 6, day 7, on day 8 and during final study evaluation (day 14). - Vital signs will be measured at screening and each visit (multiple measurements on day 1 and day 7) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy / pharmacodynamic endpoints Pharmacodynamic effects of CLS003 will be assessed at the time points indicated in the Visit and Assessment Schedule (Table 1) by • Morphological wart assessment on-site; • Wart size and morphology assessment by standardized clinical photography; • HPV viral load assessment of target lesions by quantitative PCR (exploratory biomarker).;Timepoint(s) of evaluation of this end point: PD assessments performed pre-dose on day 1, 4, 7 and during final study evaluation (day 14). Biopsy assessment will only be performed on day 14. | — |
Countries
Netherlands
Contacts
Public ContactJ. Burggraaf
Centre for Human Drug Research
Outcome results
None listed