A Clinical Investigation to Evaluate The Orkla Corn Plaster

Study Overview
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Brief Summary
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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.

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

Conditions
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Corns

Intervention / Treatment
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* Combination Product: Orkla Corn Plaster with salicylic acid
* Device: Orkla Corn Protector


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orkla corn plaster with Salicylic acid<br> | Combination Product: Orkla Corn Plaster with salicylic acid<br>* 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.<br>|
| Active Comparator: Orkla corn protector without salicylic acid<br> | Device: Orkla Corn Protector<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of improved subjects treated with Orkla Corn Plaster (with salicylic acid) at D28 compared to D0 (baseline) |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | 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 |