Clinical trial · Interventional
Clinical Trial to Evaluate Efficacy and Safety of a Cryogenic Medical Device for Treatment of Common and Plantar Warts
Prospective, Single-blinded, Randomized Trial to Evaluate the Efficacy of a Cryogenic Medical Device in Treatment of Common and Plantar Warts Versus a Comparator Product.
NCT06309420CI-TRIAL-00075009completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The present study was set-up to evaluate clinical efficacy of Pixie CO2 versus a comparator product (Wortie®) for the treatment of common and plantar warts.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Warts | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryogenic treatment of warts (Pixie CO2) | Device | — | UNRESOLVED |
| Cryogenic treatment of warts (Wortie®) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pixie CO2
- description
- Cryogenic treatment of warts (Carbonic ice tablet) Maximum 3 application by the technician in charge of the study Apply 15 seconds for a wart on hand or arm and 40 seconds for a wart on feet or toe
- interventionNames
- Device: Cryogenic treatment of warts (Pixie CO2)
- type
- ACTIVE_COMPARATOR
- label
- Wortie®
- description
- Cryogenic treatment of wart (dimethylether-based product) Maximum 3 application by the technician in charge of the study. Apply 20 seconds for a wart on hand or arm and 40 seconds for a wart on feet or toe
- interventionNames
- Device: Cryogenic treatment of warts (Wortie®)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy subject. * Sex: male or female. * Age: more than 4 years old. * Subject presenting at least 1 new common wart on hand or a plantar wart (wart present since less than 6 months) of a size less than 0.8cm. * Subject, including minors aged more than 16 years, having given freely and expressly his/her informed consent. * Minor whose legal guardians have given their free and express informed consent. * Subject who is able to comply with the study requirements, as defined in the present rotocol, at the Investigator's appreciation. * Subject or child's legal guardians being affiliated to a health social security system. * Female subject of childbearing potential should use a medically accepted contraceptive regimen (at the Investigator's discretion) since at least 12 weeks before the beginning of the study, during all the study. Exclusion Criteria: * 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. * Subject suspected to be non-compliant according to the Investigator's judgment. * Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results. * Subject with a cutaneous disease other than common and plantar warts, on the studied zone. * Subject with a known allergy to one of the component of the products or to the comparator. * Subject who has diabetes. * Subject having problems with blood circulation, or having a blood clotting condition. * Subject with immune deficiency or autoimmune disease. * Subject presenting more than 10 warts on the body. * Subject presenting bleeding warts. * Subject presenting birthmarks, moles, warts with hairs growing from them, or any other spots on the treated and surrounding area. * Subject having a sensitive skin, inflamed, infected, irritated, red, damaged, cut, grazed, diseased or itchy on the treated zone. * Subject presenting genital warts, flat warts, filiform warts, periungual warts or warts larger than 0.8cm. * Subject presenting 2 or more warts adjacent to each other. * Subject undergoing a topical treatment on the test area or a systemic treatment: * anti-inflammatory medication during the previous 2 weeks and during the study, * immunosuppressors and/or corticoids during the 4 previous weeks and during the study, * retinoids during the 6 previous months and during the study, * any medication stabilized for less than one month. * Subject who received a treatment of any type on the selected wart during the previous 6 months. * Intensive exposure to sunlight or UV-rays on the studied zone within the previous month and/or foreseen during the study. * Subject planning to change her/his life habits during the study.
References
Publications (0)
Data not yet available
No reference posted for this study.