A Clinical Investigation to Evaluate The Orkla Corn Plaster

Corns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04601259
• Other study ID #: OCI-001
• Status: Completed
• Phase: N/A
• Start date: October 21, 2020
• Est. completion date: June 10, 2021

Study information

• Verified date: September 2021
• Source: Orkla Care AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 10, 2021
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corns

Intervention

Combination Product:
• Orkla Corn Plaster with salicylic acid
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.

Device:
• Orkla Corn Protector
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.

Locations

Country	Name	City	State
Sweden	Carlanderska Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Orkla Care AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Percentage of improved subjects treated with Orkla Corn Plaster (with salicylic acid) at D28 compared to D0 (baseline)		28 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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