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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orkla corn plaster with Salicylic acid | Experimental |
| |
| Orkla corn protector without salicylic acid | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of improved subjects treated with Orkla Corn Plaster (with salicylic acid) at D28 compared to D0 (baseline) | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 28 days | |
| Percentage of improved subjects at D14, 3 and 6 months compared to baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felix Lundin | Carlanderska Hospital, Carlandersparken 1, 405 45 Göteborg, Sweden. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carlanderska Hospital | Gothenburg | 405 45 | Sweden |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 8, 2022 | |
| Reset | Oct 11, 2023 | |
| Release | Oct 16, 2023 | |
| Reset | Apr 5, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 8, 2022 | Oct 11, 2023 | |||
| Oct 16, 2023 |
| ID | Term |
|---|---|
| D002145 | Callosities |
| ID | Term |
|---|---|
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D020156 | Salicylic Acid |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| 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. |
|
Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 28 days |
| Apr 5, 2024 |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |