A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Study to Evaluate Efficacy and Safety of Topical Ionic Contra-viral Therapy (ICVT) Comprised of CLS003 in Cutaneous Warts
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Maruho Co., Ltd.
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Change in the HPV viral load
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
CLS003
Topical digoxin/furosemide
Intervention: CLS003 (Drug)
Digoxin topical formulation
Intervention: Digoxin (Drug)
Furosemide topical formulation
Intervention: Furosemide (Drug)
Vehicle topical formulation
Intervention: Vehicle topical (Drug)
Outcomes
Primary Outcomes
Change in the HPV viral load
Time Frame: Days 14, 28, 42, 70, 98
Change from baseline in morphological wart assessment
Time Frame: Days 14, 28, 42, 70, 98
Change from baseline in HPV viral load assessment of target lesions by quantitative PCR
Time Frame: Days 14, 28, 42, 70, 98
Change from baseline in Wart size and morphology assessment by standardized clinical photography
Time Frame: Days 14, 28, 42, 70, 98
Reduction in wart size
Time Frame: Days 14, 28, 42, 70, 98
Change from baseline in mean HPV viral load
Time Frame: Days 14, 28, 42, 70, 98
Percent clearance of warts
Time Frame: Days 14, 28, 42, 70, 98
Secondary Outcomes
- Adverse event to evaluate safety and tolerability of CLS003(Days 0-98)