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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cutaneous Warts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CLS003

Topical digoxin/furosemide

Group Type EXPERIMENTAL

CLS003

Intervention Type DRUG

Digoxin topical formulation

Group Type EXPERIMENTAL

Digoxin

Intervention Type DRUG

Furosemide topical formulation

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

Vehicle topical formulation

Group Type PLACEBO_COMPARATOR

Vehicle topical

Intervention Type DRUG

Interventions

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CLS003

Intervention Type DRUG

Furosemide

Intervention Type DRUG

Digoxin

Intervention Type DRUG

Vehicle topical

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No