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

Cutaneous Warts Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02333643
• Other study ID #: CLS003-CO-PR-002
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2014
• Last updated: July 25, 2016
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: July 2016
• Source: Cutanea Life Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous Warts
• Warts

Intervention

Drug:
• CLS003

• Furosemide

• Digoxin

• Vehicle topical

Locations

Country	Name	City	State
Netherlands	LUMC/Centre for Human Drug Research	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Cutanea Life Sciences, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in morphological wart assessment		Days 14, 28, 42, 70, 98	No
Primary	Change from baseline in Wart size and morphology assessment by standardized clinical photography		Days 14, 28, 42, 70, 98	No
Primary	Change from baseline in HPV viral load assessment of target lesions by quantitative PCR		Days 14, 28, 42, 70, 98	No
Primary	Reduction in wart size		Days 14, 28, 42, 70, 98	No
Primary	Change in the HPV viral load		Days 14, 28, 42, 70, 98	No
Primary	Change from baseline in mean HPV viral load		Days 14, 28, 42, 70, 98	No
Primary	Percent clearance of warts		Days 14, 28, 42, 70, 98	No
Secondary	Adverse event to evaluate safety and tolerability of CLS003		Days 0-98	Yes