Efficacy of Home Use of Hyperthermia to Improve Plantar Wart Clearance Rate with Topical Salicylic Acid/5-FU Therapy - A Randomized, Placebo-controlled, Double-blind Clinical Trial
Not Applicable
- Conditions
- B07Viral warts
- Registration Number
- DRKS00034578
- Lead Sponsor
- Hautpartner Lübeck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
patients aged 18 and over
- presence of plantar warts
- presence of a compatible smartphone
- signed consent
Exclusion Criteria
- patients under 18 years of age
- patients unable to consent
- Diabetes mellitus
- Polyneuropathy
- Pregnancy/breastfeeding
- intolerance to salicylic acid or 5-F
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Home use with hyperthermia (heat-it®) results in a significantly higher clinical clearance of plantar warts than in the placebo group.<br>The endpoint is considered to be the healing of the plantar wart. After applying the intervention twice daily, the participant will have a visit every four weeks for a total of three months. During these visits, a light microscopy photodocumentation will be conducted, and excess keratin material will be curetted. Once the wart is no longer detectable via light microscopy, the therapy will be concluded. In addition to the photodocumentation, questionnaires will be completed at each visit by both the participant and the study coordinator.
- Secondary Outcome Measures
Name Time Method - tolerability of therapy<br>- increasing the quality of life during therapy<br>The endpoint is considered to be the healing of the plantar wart. After applying the intervention twice daily, the participant will have a visit every four weeks for a total of three months. During these visits, a light microscopy photodocumentation will be conducted, and excess keratin material will be curetted. Once the wart is no longer detectable via light microscopy, the therapy will be concluded. In addition to the photodocumentation, questionnaires will be completed at each visit by both the participant (regarding application, pain, side effects, DLQI questionnaire) and the study leader (inquiries about light microscopy characteristics).