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

Orkla Care AB1 site in 1 country55 target enrollmentOctober 21, 2020

ConditionsCorns

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Corns
Sponsor: Orkla Care AB
Enrollment: 55
Locations: 1
Primary Endpoint: Percentage of improved subjects treated with Orkla Corn Plaster (with salicylic acid) at D28 compared to D0 (baseline)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 21, 2020

End Date

June 10, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Orkla Care AB

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Percentage of improved subjects treated with Orkla Corn Plaster (with salicylic acid) at D28 compared to D0 (baseline)

Time Frame: 28 days

Secondary Outcomes

Resolution of corn at D14, D28, 3 and 6 months(14 days, 28 days, 3 months and 6 months)
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)
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)
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 with recurrence at D14, D28, 3 and 6 months(14 days, 28 days, 3 months and 6 months)
Corn size reduction (mm) at D14, D28, 3 and 6 months(14 days, 28 days, 3 months and 6 months)
Subject treatment satisfaction questionnaire: Overall treatment satisfaction assessed via subject-reported question with a 5-point qualitative scale(28 days)
Subject treatment satisfaction questionnaire: Product recommendation assessed via subject-reported question with answer alternatives Yes/No/Don't know(28 days)
Investigator treatment satisfaction questionnaire: Product recommendation assessed via investigator-reported questionnaire with answer alternatives Yes/No/Don't know(28 days)
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)
Subject treatment satisfaction questionnaire: Corn appearance improvement assessed via subject-reported question with a 5-point qualitative scale(28 days)
Subject reported resolution point of time (diary)(Up to 6 months)
Usability questionnaire: Ease of application assessed via subject-reported question with a 5-point qualitative scale.(14 days, 28 days)
Investigator treatment satisfaction questionnaire: Overall treatment satisfaction assessed via investigator-reported question with a 5-point qualitative scale(28 days)
Investigator treatment satisfaction questionnaire: Corn appearance improvement assessed via investigator-reported questionnaire with a 5-point qualitative scale(28 days)