A study in volunteers with cutaneous warts to assess safety and the effect of the body on topical ionic contra-viral therapy (ICVT) comprised of digoxin and furosemide.

• Conditions: Cutaneous warts; MedDRA version: 16.1Level: HLTClassification code 10033724Term: Papilloma viral infectionsSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-005569-38-NL
• Lead Sponsor: Cutanea Life Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-04
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified