- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04601259
A Clinical Investigation to Evaluate The Orkla Corn Plaster
September 8, 2021 updated by: Orkla Care AB
A Prospective, Randomized, Controlled, Open-labelled Investigation to Assess Performance and Safety of Orkla Corn Plaster
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Gothenburg, Sweden, 405 45
- Carlanderska Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
ACTIVE_COMPARATOR: Orkla corn protector without salicylic acid
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of improved subjects treated with Orkla Corn Plaster (with salicylic acid) at D28 compared to D0 (baseline)
Time Frame: 28 days
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: 28 days
|
28 days
|
|
Percentage of improved subjects at D14, 3 and 6 months compared to baseline.
Time Frame: 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.
|
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.
Time Frame: 14 days, 28 days, 3 months and 6 months
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Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.
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14 days, 28 days, 3 months and 6 months
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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
Time Frame: Before and immediately after plaster application
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Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.
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Before and immediately after plaster application
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Resolution of corn at D14, D28, 3 and 6 months
Time Frame: 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.
|
14 days, 28 days, 3 months and 6 months
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Subject reported resolution point of time (diary)
Time Frame: Up to 6 months
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Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.
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Up to 6 months
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Percentage of subjects with recurrence at D14, D28, 3 and 6 months
Time Frame: 14 days, 28 days, 3 months and 6 months
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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
Time Frame: 14 days, 28 days, 3 months and 6 months
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Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.
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14 days, 28 days, 3 months and 6 months
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Usability questionnaire: Ease of application assessed via subject-reported question with a 5-point qualitative scale.
Time Frame: 14 days, 28 days
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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.
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14 days, 28 days
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Usability questionnaire: Adherence to the application site assessed via subject-reported question with a 5-point qualitative scale.
Time Frame: 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.
|
14 days, 28 days
|
Subject treatment satisfaction questionnaire: Overall treatment satisfaction assessed via subject-reported question with a 5-point qualitative scale
Time Frame: 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.
|
28 days
|
Subject treatment satisfaction questionnaire: Corn appearance improvement assessed via subject-reported question with a 5-point qualitative scale
Time Frame: 28 days
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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
Time Frame: 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.
|
28 days
|
Investigator treatment satisfaction questionnaire: Overall treatment satisfaction assessed via investigator-reported question with a 5-point qualitative scale
Time Frame: 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.
|
28 days
|
Investigator treatment satisfaction questionnaire: Corn appearance improvement assessed via investigator-reported questionnaire with a 5-point qualitative scale
Time Frame: 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.
|
28 days
|
Investigator treatment satisfaction questionnaire: Product recommendation assessed via investigator-reported questionnaire with answer alternatives Yes/No/Don't know
Time Frame: 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.
|
28 days
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: 6 months
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Felix Lundin, Carlanderska Hospital, Carlandersparken 1, 405 45 Göteborg, Sweden.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 21, 2020
Primary Completion (ACTUAL)
January 14, 2021
Study Completion (ACTUAL)
June 10, 2021
Study Registration Dates
First Submitted
October 13, 2020
First Submitted That Met QC Criteria
October 19, 2020
First Posted (ACTUAL)
October 23, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 9, 2021
Last Update Submitted That Met QC Criteria
September 8, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Keratosis
- Callosities
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Dermatologic Agents
- Antifungal Agents
- Keratolytic Agents
- Salicylic Acid
- Salicylates
Other Study ID Numbers
- OCI-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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