Completed

Clinical Trial to Demonstrate the Comparative Efficacy of a Cryogenic Treatment (Medical Device) In Common and Plantar Warts Management

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What is being tested

Cryogenic treatment of warts

Device
Who is being recruted

DNA Virus Infections+7

+ Infections

+ Skin Diseases

Over 4 Years
+36 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2015
See protocol details

Summary

Principal SponsorOystershell NV
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2015

Actual date on which the first participant was enrolled.

The use of cryotherapy has been long known to be effective against warts. The indications for Pixie® are in line with the indications presented in the collected literature data, as well as with the indications of equivalent devices. The benefits of warts treatment without the use of chemicals are clearly evidenced. The treatment period is much shorter (one treatment compared to daily application of keratinolytics or fluorouracil, over a period of a few weeks). The cryogen therapy application through a conic tip is much more precise than with chemical substances. Chemical substance application is leading to more side effects of the surrounding skin (typical for chemical treatment are pain, blistering, ulceration and contact dermatitis). The Instructions for Use were developed in line with these data and are therefore covering all hazards known up to the date of this report. Based on these data the product received its CE-mark approval

Official TitleClinical Trial to Demonstrate the Comparative Efficacy of a Cryogenic Treatment (Medical Device) In Common and Plantar Warts Management
NCT03129373
Principal SponsorOystershell NV
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

138 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 4 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DNA Virus InfectionsInfectionsSkin DiseasesSkin Diseases, InfectiousTumor Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralSkin and Connective Tissue DiseasesPapillomavirus Infections

Criteria

10 inclusion criteria required to participate
Healthy subject.
Sex: male or female.
Age: more than 4 years old.
Subject presenting at least 1 new common wart on hand or on feet or plantar wart (wart present since less than 6 months).
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26 exclusion criteria prevent from participating
Pregnant, parturient or nursing woman or planning a pregnancy during the study.
Subject who had been deprived of their freedom by administrative or legal decision.
Subject in a social or sanitary establishment.
Major subject who is under guardianship or who is not able to express his consent.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Cryogenic treatment of wart (liquified nitrous oxide) * Maximum 3 application by the technician in charge of the study. * Apply between 15 to 20 sec on hand and 40 sec on feet.

Group II

Active Comparator
Cryogenic treatment of wart (dimethylether propane-based): * Maximum 3 application by the technician in charge of the study. * Apply between 15 to 20 sec on hand and 40 sec on feet.

Group III

Active Comparator
Cryogenic treatment of wart (dimethylether-based product): * Maximum 3 application by the technician in charge of the study. * Apply between 15 to 20 sec on hand and 40 sec on feet.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers