An interventional study of Orkla Corn Plaster with salicylic acid and Orkla Corn Protector in Corns, sponsored by Orkla Care AB. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-09.
Sponsored by Orkla Care AB · Not applicable, Interventional, and Treatment
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.
This is the only study on the registry with Orkla Care AB as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Combination Product: Orkla Corn Plaster with salicylic acid
Device: Orkla Corn Protector
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.
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.
Percentage of improved subjects treated with Orkla Corn Plaster (with salicylic acid) at D28 compared to D0 (baseline)
Time frame: 28 days
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
Percentage of improved subjects at D14, 3 and 6 months compared to baseline.
Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.
Time frame: 14 days, 3 months and 6 months
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.
Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.
Time frame: 14 days, 28 days, 3 months and 6 months
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
Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.
Time frame: Before and immediately after plaster application
Resolution of corn at D14, D28, 3 and 6 months
Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.
Time frame: 14 days, 28 days, 3 months and 6 months
Subject reported resolution point of time (diary)
Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.
Time frame: Up to 6 months
Percentage of subjects with recurrence at D14, D28, 3 and 6 months
Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.
Time frame: 14 days, 28 days, 3 months and 6 months
Corn size reduction (mm) at D14, D28, 3 and 6 months
Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.
Time frame: 14 days, 28 days, 3 months and 6 months
Usability questionnaire: Ease of application assessed via subject-reported question with a 5-point qualitative scale.
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.
Time frame: 14 days, 28 days
Usability questionnaire: Adherence to the application site assessed via subject-reported question with a 5-point qualitative scale.
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.
Time frame: 14 days, 28 days
Subject treatment satisfaction questionnaire: Overall treatment satisfaction assessed via subject-reported question with a 5-point qualitative scale
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.
Time frame: 28 days
Subject treatment satisfaction questionnaire: Corn appearance improvement assessed via subject-reported question with a 5-point qualitative scale
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.
Time frame: 28 days
Subject treatment satisfaction questionnaire: Product recommendation assessed via subject-reported question with answer alternatives Yes/No/Don't know
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.
Time frame: 28 days
Investigator treatment satisfaction questionnaire: Overall treatment satisfaction assessed via investigator-reported question with a 5-point qualitative scale
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.
Time frame: 28 days
Investigator treatment satisfaction questionnaire: Corn appearance improvement assessed via investigator-reported questionnaire with a 5-point qualitative scale
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.
Time frame: 28 days
Investigator treatment satisfaction questionnaire: Product recommendation assessed via investigator-reported questionnaire with answer alternatives Yes/No/Don't know
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.
Time frame: 28 days
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
Plan to share: No
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