Clinical trial NCT04601259: A Clinical Investigation to Evaluate The Orkla Corn Plaster
Official title: A Prospective, Randomized, Controlled, Open-labelled Investigation to Assess Performance and Safety of Orkla Corn Plaster
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corns
Lead sponsor: Orkla Care AB
Sponsor class: INDUSTRY
First posted: 2020-10-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of improved subjects treated with Orkla Corn Plaster (with salicylic acid) at D28 compared to D0 (baseline)
timeFrame: 28 days
Secondary outcomes:
measure: 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)
timeFrame: 28 days
measure: Percentage of improved subjects at D14, 3 and 6 months compared to baseline.
timeFrame: 14 days, 3 months and 6 months
measure: 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.
timeFrame: 14 days, 28 days, 3 months and 6 months
measure: 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
timeFrame: Before and immediately after plaster application
measure: Resolution of corn at D14, D28, 3 and 6 months
timeFrame: 14 days, 28 days, 3 months and 6 months
measure: Subject reported resolution point of time (diary)
timeFrame: Up to 6 months
measure: Percentage of subjects with recurrence at D14, D28, 3 and 6 months
timeFrame: 14 days, 28 days, 3 months and 6 months
measure: Corn size reduction (mm) at D14, D28, 3 and 6 months
timeFrame: 14 days, 28 days, 3 months and 6 months
measure: Usability questionnaire: Ease of application assessed via subject-reported question with a 5-point qualitative scale.
timeFrame: 14 days, 28 days
measure: Usability questionnaire: Adherence to the application site assessed via subject-reported question with a 5-point qualitative scale.
timeFrame: 14 days, 28 days
measure: Subject treatment satisfaction questionnaire: Overall treatment satisfaction assessed via subject-reported question with a 5-point qualitative scale
timeFrame: 28 days
measure: Subject treatment satisfaction questionnaire: Corn appearance improvement assessed via subject-reported question with a 5-point qualitative scale
timeFrame: 28 days
measure: Subject treatment satisfaction questionnaire: Product recommendation assessed via subject-reported question with answer alternatives Yes/No/Don't know
timeFrame: 28 days
measure: Investigator treatment satisfaction questionnaire: Overall treatment satisfaction assessed via investigator-reported question with a 5-point qualitative scale
timeFrame: 28 days
measure: Investigator treatment satisfaction questionnaire: Corn appearance improvement assessed via investigator-reported questionnaire with a 5-point qualitative scale
timeFrame: 28 days
measure: Investigator treatment satisfaction questionnaire: Product recommendation assessed via investigator-reported questionnaire with answer alternatives Yes/No/Don't know
timeFrame: 28 days
Other outcomes:
measure: 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.
timeFrame: 6 months
Locations:
city: Gothenburg
country: Sweden
facility: Carlanderska Hospital
Study officials:
affiliation: Carlanderska Hospital, Carlandersparken 1, 405 45 Göteborg, Sweden.
name: Felix Lundin
role: PRINCIPAL_INVESTIGATOR
References: