First-in-Human Study of CLS003 ICVT in Subjects With Cutaneous Warts (NCT02106260) | Clinical Trial Compass
CompletedPhase 1/2
First-in-Human Study of CLS003 ICVT in Subjects With Cutaneous Warts
Netherlands12 participantsStarted 2014-03
Plain-language summary
This phase I/IIa study has an open-label, First-in-Human (FIH), single center design to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of topically applied CLS003 in healthy subjects 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:
* Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive.
* Body mass index (BMI) between 18 and 30kg/m2, inclusive
* Fitzpatrick skin type I-II-III-IV
* At least 4 cutaneous warts on the hands, separated by at least 1cm of skin
Exclusion Criteria:
* For women, a positive pregnancy test and/or nursing at screening
* A positive test for drugs of abuse at screening
* History of alcohol or illicit drug abuse
* 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 enrollment
* Have received cryotherapy in the treatment area within 60 days prior to enrollment
* Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) with 30 days prior to enrollment or during the course of the study.
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
Area under the plasma concentration versus time curve (AUC) of CLS003