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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00034578

Enrollment

Registered

2024-07-30

Start date

2024-09-16

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B07

Interventions

Group 1: heat it verum device (temp.: 47-52 °C) + topical Salicylic Acid/5-FU - application of the intervention in both groups twice daily - visits/checks every four weeks for a total of three months

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - patients aged 18 and over - presence of plantar warts - presence of a compatible smartphone - signed consent

Exclusion criteria

Exclusion criteria: - patients under 18 years of age - patients unable to consent - Diabetes mellitus - Polyneuropathy - Pregnancy/breastfeeding - intolerance to salicylic acid or 5-FU

Design outcomes

Primary

Measure	Time frame
Home use with hyperthermia (heat-it®) results in a significantly higher clinical clearance of plantar warts than in the placebo group. 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.	—

Measure

Time frame

Home use with hyperthermia (heat-it®) results in a significantly higher clinical clearance of plantar warts than in the placebo group. 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

Measure	Time frame
- tolerability of therapy - increasing the quality of life during therapy 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).	—

Measure

Time frame

- tolerability of therapy - increasing the quality of life during therapy 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).

—

Countries

Germany

Contacts

Public ContactSven Krengel

Hautpartner Lübeck

krengel@hautpartner.de045187929480

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026