A Clinical Investigation to Evaluate The Orkla Corn Plaster

Not Applicable

Completed

• Conditions: Corns
• Interventions: Combination Product: Orkla Corn Plaster with salicylic acid; Device: Orkla Corn Protector

• Registration Number: NCT04601259
• Lead Sponsor: Orkla Care AB

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-19
• Study Start: 2020-10-21
• Study First Posted: 2020-10-23
• Primary Completion: 2021-01-14
• Study Completion: 2021-06-10
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. Signed Informed Consent Form
2. >18 years of age
3. Presence of corn(s) confirmed by Investigator
4. Corn included into investigation shall not have been subject to any other treatment 1 month prior to study enrolment.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orkla corn plaster with Salicylic acid	Orkla Corn Plaster with salicylic acid	-
Orkla corn protector without salicylic acid	Orkla Corn Protector	-

Primary Outcome Measures

Name	Time	Method
Percentage of improved subjects treated with Orkla Corn Plaster (with salicylic acid) at D28 compared to D0 (baseline)	28 days

Secondary Outcome Measures

Name	Time	Method
Resolution of corn at D14, D28, 3 and 6 months	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.
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.	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.
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	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.
Usability questionnaire: Adherence to the application site assessed via subject-reported question with a 5-point qualitative scale.	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.
Percentage of subjects with recurrence at D14, D28, 3 and 6 months	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.
Corn size reduction (mm) at D14, D28, 3 and 6 months	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.
Subject treatment satisfaction questionnaire: Overall treatment satisfaction assessed via subject-reported question with a 5-point qualitative scale	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.
Subject treatment satisfaction questionnaire: Product recommendation assessed via subject-reported question with answer alternatives Yes/No/Don't know	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.
Investigator treatment satisfaction questionnaire: Product recommendation assessed via investigator-reported questionnaire with answer alternatives Yes/No/Don't know	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.
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.	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.
Subject treatment satisfaction questionnaire: Corn appearance improvement assessed via subject-reported question with a 5-point qualitative scale	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.
Subject reported resolution point of time (diary)	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.
Usability questionnaire: Ease of application assessed via subject-reported question with a 5-point qualitative scale.	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.
Investigator treatment satisfaction questionnaire: Overall treatment satisfaction assessed via investigator-reported question with a 5-point qualitative scale	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.
Investigator treatment satisfaction questionnaire: Corn appearance improvement assessed via investigator-reported questionnaire with a 5-point qualitative scale	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.

Trial Locations

Locations (1)

Carlanderska Hospital; 🇸🇪 Gothenburg, Sweden