Clinical trial · Interventional
Microwave Treatment of Common and Plantar Warts
Pivotal Study to Assess the Clinical Efficacy and Safety of Microwave Treatment in Warts
NCT05371834CI-TRIAL-00077319unknownN/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)
This is a multi-center, open, randomized, parallel-group, controlled, blind-assessed trial of approximately 124 subjects that require treatment for up to 5 common or plantar warts. Subjects will be randomized to one of two treatment groups: Microwave Treatment (Swift® system) or Cryotherapy.
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 |
|---|---|---|---|
| Cryotherapy | Device | — | UNRESOLVED |
| Microwave Treatment (Swift System) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Microwave Treatment (Swift System)
- description
- 5-10 Watts of microwave energy applied locally on each wart for a 2-3 second burst with 3-5 repetitions per lesion.
- interventionNames
- Device: Microwave Treatment (Swift System)
- type
- ACTIVE_COMPARATOR
- label
- Cryotherapy Treatment
- description
- For each wart, two cycles of cryotherapy treatment is administered.
- interventionNames
- Device: Cryotherapy
Primary outcomes (1)
- measure
- Clearance of all treated warts, each of which is defined as "resolved" or "not resolved" based on the classification by the blinded site investigator assessing the treated warts at three months post final treatment (up to 5 warts in total).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of signed and dated informed consent form; 2. Stated willingness to comply with all study procedures and availability for the duration of the study; 3. Age 18-64 years inclusive; 4. A minimum of one clinically significant common wart (usually found on hands, knees and elbows), or one plantar wart. Note: the warts for treatment cannot be a mixture of common and plantar warts; 5. Subject's common warts must measure between 3mm-10mm or for plantar warts, measure between 3mm-20mm, inclusive; 6. If currently receiving treatment for common or plantar warts, agree to stop their current medication for at least 28 days prior to the start of study treatment; 7. Agrees to refrain from using any other wart removal products or treatments during the study period; 8. Agrees to not take any non-steroidal anti-inflammatory drugs (NSAIDs) or antihistamines within a 12-hour period prior to and after randomized treatment; 9. Able to perform study assessments. Exclusion Criteria: 1. Pregnancy or breast feeding; 2. Mosaic warts for treatment; 3. Warts (common or plantar) that have been reported by the subject as present for more than 5 years (relates to any wart present and which may not necessarily be treated in this study); 4. Warts for treatment on areas of thin or sensitive skin as determined by the Investigator, e.g., face, neck, armpits, breasts, buttocks or genitals; 5. Areas for treatment where the skin is irritated, reddened or showing any sign of inflammation (e.g. itching and swelling); 6. Warts for treatment with hair growth, birthmarks, dark moles, pigmented skin or any other unusual skin condition; 7. History of infection in designated treatment area within 90 days prior to first treatment; 8. Implantable Cardioverter Defibrillator (ICD), pacemaker or other implantable electronic devices; 9. Metal implants at site of treatment (within foot or ankle); 10. Known allergy or intolerance to microwave therapy and cryotherapy; 11. Unstable co-morbidities (cardiovascular disease, active malignancy, inflammatory arthritis); 12. Participating in another interventional study or have done so within the last 30-days; 13. Anticipated relocation or extensive travel outside of the local study area preventing compliance with study procedures; 14. Circulatory conditions affecting the acral areas - peripheral vascular disease, peripheral ischemia, vasculitis, Raynaud's, or related conditions; 15. Peripheral neuropathy; 16. Subject with known immunosuppression disorders through illness or medication (for example - corticosteroids, biologic agents, methotrexate, ciclosporin); 17. Subject with autoimmune disease; 18. Diabetes (Type I or II); 19. History of vascular interventions to the legs, deemed as an unacceptable risk by the Investigator; 20. Prior dissection of axillary lymph nodes (for treated hand) or inguinal lymph nodes (for treated feet); 21. Dependent lymphedema; 22. Congestive heart failure; 23. History of repeated cellulitis (2 or more episodes); 24. History of deep venous thrombosis; 25. Subject currently receiving prescribed blood thinning medication; 26. Subject who has ever had any topical metallic treatment (e.g, aluminum chloride, silver nitrate) within the past year.
References
Publications (0)
Data not yet available
No reference posted for this study.