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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 assessment

Change 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

Page last updated: August 23, 2015

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