A Phase 2 Efficacy Study of CLS003 ICVT in Subjects With Cutaneous Warts. (NCT02333643) | Clinical Trial Compass
CompletedPhase 2
A Phase 2 Efficacy Study of CLS003 ICVT in Subjects With Cutaneous Warts.
Netherlands81 participantsStarted 2015-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, E…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in morphological wart assessment
Timeframe: Days 14, 28, 42, 70, 98
2
Change from baseline in Wart size and morphology assessment by standardized clinical photography
Timeframe: Days 14, 28, 42, 70, 98
3
Change from baseline in HPV viral load assessment of target lesions by quantitative PCR