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Completed

NCT Number: NCT04601259

A Clinical Investigation to Evaluate The Orkla Corn Plaster

This is a prospective, randomized, controlled, open-labelled investigation to assess performance and safety of Orkla Corn Plaster in subject with corns. The hypothesis is that there is an improvement in the size of corns at day 28 compared to baseline.

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Key information

Conditions

Corns Callosities Keratosis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carlanderska Hospital

Gothenburg, 405 45, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed Informed Consent Form
  • >18 years of age
  • Presence of corn(s) confirmed by Investigator
  • Corn included into investigation shall not have been subject to any other treatment 1 month prior to study enrolment.

Exclusion criteria

  • Pregnant or lactating women at time of enrolment
  • Subjects with hypersensitivity to salicylic acid/salicylates, polyethylene foil, acrylic adhesive, viscose/polyethylene fibers and azorubine
  • Subjects diagnosed with diabetes
  • Subjects with poor peripheral blood circulation
  • Subjects with renal dysfunction (eGFR <60 mL/min/1.73 m2)
  • Subjects with ongoing skin disease in the area where the index corn is located.
  • Subjects with any other condition that as judged by the investigator may make follow-up or investigations procedures inappropriate
  • Any subject that according to the Declaration of Helsinki is unsuitable for enrollment

Treatment and study plan

Orkla Corn Plaster with salicylic acid

Combination Product

Each participating subject will receive Orkla Corn Plasters for usage up to 28 days, or until corn resolution whichever comes first. Subjects will be instructed to change plasters daily.

Orkla Corn Protector

Device

Each participating subject will receive Orkla Corn Protector for usage up to 28 days, or until corn resolution whichever comes first. Subjects will be instructed to change plasters daily.

Primary outcomes

  1. Percentage of improved subjects treated with Orkla Corn Plaster (with salicylic acid) at D28 compared to D0 (baseline)

    Time frame: 28 days

Secondary outcomes

  1. Difference in percentage of improved subjects from D0 (baseline) to D28 between Orkla Corn Plaster (with salicylic acid) and Orkla Corn Protector (without salicylic acid)

    Time frame: 28 days

  2. Percentage of improved subjects at D14, 3 and 6 months compared to baseline.

    Time frame: 14 days, 3 months and 6 months

    Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.

  3. Pain experienced from index corn recorded on Visual Analog Scale (VAS; scale: 0-100 mm where a higher score corresponds to worse pain) at D14, D28, 3 and 6 months compared to baseline.

    Time frame: 14 days, 28 days, 3 months and 6 months

    Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.

  4. Pain assessment recorded on Visual Analog Scale (VAS; scale: 0-100 mm where a higher score corresponds to worse pain) before and immediately after plaster application

    Time frame: Before and immediately after plaster application

    Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.

  5. Resolution of corn at D14, D28, 3 and 6 months

    Time frame: 14 days, 28 days, 3 months and 6 months

    Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.

  6. Subject reported resolution point of time (diary)

    Time frame: Up to 6 months

    Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.

  7. Percentage of subjects with recurrence at D14, D28, 3 and 6 months

    Time frame: 14 days, 28 days, 3 months and 6 months

    Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.

  8. Corn size reduction (mm) at D14, D28, 3 and 6 months

    Time frame: 14 days, 28 days, 3 months and 6 months

    Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.

  9. Usability questionnaire: Ease of application assessed via subject-reported question with a 5-point qualitative scale.

    Time frame: 14 days, 28 days

    Percentage of subjects selecting a given answer is presented with comparisons within the Orkla Corn Plaster group, and comparisons between the two treatment groups, Orkla Corn Plaster vs. Orkla Corn Protector.

  10. Usability questionnaire: Adherence to the application site assessed via subject-reported question with a 5-point qualitative scale.

    Time frame: 14 days, 28 days

    Percentage of subjects selecting a given answer is presented with comparisons within the Orkla Corn Plaster group, and comparisons between the two treatment groups, Orkla Corn Plaster vs. Orkla Corn Protector.

  11. Subject treatment satisfaction questionnaire: Overall treatment satisfaction assessed via subject-reported question with a 5-point qualitative scale

    Time frame: 28 days

    Percentage of subjects selecting a given answer is presented with comparisons within the Orkla Corn Plaster group, and comparisons between the two treatment groups, Orkla Corn Plaster vs. Orkla Corn Protector.

  12. Subject treatment satisfaction questionnaire: Corn appearance improvement assessed via subject-reported question with a 5-point qualitative scale

    Time frame: 28 days

    Percentage of subjects selecting a given answer is presented with comparisons within the Orkla Corn Plaster group, and comparisons between the two treatment groups, Orkla Corn Plaster vs. Orkla Corn Protector.

  13. Subject treatment satisfaction questionnaire: Product recommendation assessed via subject-reported question with answer alternatives Yes/No/Don't know

    Time frame: 28 days

    Percentage of subjects selecting a given answer is presented with comparisons within the Orkla Corn Plaster group, and comparisons between the two treatment groups, Orkla Corn Plaster vs. Orkla Corn Protector.

  14. Investigator treatment satisfaction questionnaire: Overall treatment satisfaction assessed via investigator-reported question with a 5-point qualitative scale

    Time frame: 28 days

    Percentage of subjects for each answer alternative (judged by investigator) is presented with comparisons within the Orkla Corn Plaster group, and comparisons between the two treatment groups, Orkla Corn Plaster vs. Orkla Corn Protector.

  15. Investigator treatment satisfaction questionnaire: Corn appearance improvement assessed via investigator-reported questionnaire with a 5-point qualitative scale

    Time frame: 28 days

    Percentage of subjects for each answer alternative (judged by investigator) is presented with comparisons within the Orkla Corn Plaster group, and comparisons between the two treatment groups, Orkla Corn Plaster vs. Orkla Corn Protector.

  16. Investigator treatment satisfaction questionnaire: Product recommendation assessed via investigator-reported questionnaire with answer alternatives Yes/No/Don't know

    Time frame: 28 days

    Percentage of subjects for each answer alternative (judged by investigator) is presented with comparisons within the Orkla Corn Plaster group, and comparisons between the two treatment groups, Orkla Corn Plaster vs. Orkla Corn Protector.

Other outcomes

  1. Incidence of adverse events (AE), adverse device effects (ADE), serious adverse events (SAE), and serious adverse device effects (SADE), and device deficiency (DD) throughout the clinical investigation.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Orkla Care AB

Industry

Registry information

Official study title

A Prospective, Randomized, Controlled, Open-labelled Investigation to Assess Performance and Safety of Orkla Corn Plaster

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 23, 2020
Registry last updated
Sep 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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