A Phase 2 Efficacy Study of CLS003 ICVT in Subjects With Cutaneous Warts.

Maruho

Status and phase: Completed; Phase 2

Conditions: Cutaneous Warts

Treatments: Drug: CLS003; Drug: Furosemide; Drug: Vehicle topical; Drug: Digoxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02333643

CLS003-CO-PR-002

Details and patient eligibility

About

A phase 2, randomized, vehicle-controlled, double-blind study to assess the efficacy, safety and pharmacodynamics (PD) of topically applied CLS003 in otherwise healthy patients with cutaneous warts.

Enrollment: 81 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• absence of evidence of any active or chronic disease;
• Free of clinical significant systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of Adverse Events;
• Have at least 2 (non-subungual) common warts or at least 2 plantar warts on non-genital, nonfacial skin

Exclusion criteria

• Any clinically significant abnormality that in the opinion of the investigator would interfere with the study objectives or compromise subject safety;
• For women: a positive pregnancy test and/or nursing at screening or women who plan to become pregnant or are breastfeeding;
• A positive test for drugs of abuse at screening;
• History of alcohol or illicit drug abuse (alcohol abuse defined as alcohol consumption > 28 units/week);
• Positive test results for Hepatitis B, Hepatitis C or HIV;
• Have used salicylic acid or any other over-the-counter wart-removing product in the treatment area within 30 days prior to starting the study or cryotherapy within 60 days of starting the study;
• Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 30 days prior to enrollment or during the course of the study. Routine use of inhaled or intranasal corticosteroids during the study is allowed;
• Have a known sensitivity to any of the investigational product ingredients
• Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings at screening;
• Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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81 participants in 4 patient groups, including a placebo group

CLS003

Experimental group

Description:

Topical digoxin/furosemide

Treatment:

Drug: CLS003

Digoxin topical formulation

Experimental group

Treatment:

Drug: Digoxin

Furosemide topical formulation

Experimental group

Treatment:

Drug: Furosemide

Vehicle topical formulation

Placebo Comparator group

Treatment:

Drug: Vehicle topical