A Phase 2 Efficacy Study of CLS003 ICVT in Subjects With Cutaneous Warts.
Information source: Cutanea Life Sciences, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cutaneous Warts
Intervention: CLS003 (Drug); Furosemide (Drug); Digoxin (Drug); Vehicle topical (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Cutanea Life Sciences, Inc. Official(s) and/or principal investigator(s): J. (Koos) Burggraaf, MD, PhD, Principal Investigator, Affiliation: Centre for Human Drug Research
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change from baseline in morphological wart assessmentChange from baseline in Wart size and morphology assessment by standardized clinical photography Change from baseline in HPV viral load assessment of target lesions by quantitative PCR Reduction in wart size Change in the HPV viral load Change from baseline in mean HPV viral load Percent clearance of warts
Secondary outcome: Adverse event to evaluate safety and tolerability of CLS003
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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;
Locations and Contacts
LUMC/Centre for Human Drug Research, Leiden, Netherlands
Additional Information
Starting date: January 2015
Last updated: May 28, 2015
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