CornsNCT04601259
A Clinical Investigation to Evaluate The Orkla Corn Plaster
A study testing Orkla Corn Plaster with salicylic acid and Orkla Corn Protector in people with Corns, run by Orkla Care AB at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corns
- What is being tested?
- Orkla Corn Plaster with salicylic acid and Orkla Corn Protector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSweden
- Study dates
- 21 Oct 2020to 10 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Corns
- Being tested
- Orkla Corn Plaster with salicylic acid, Orkla Corn Protector
- Medical subject headings
- Callosities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orkla Corn Plaster with salicylic acidCombination product
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.
Orkla Corn ProtectorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Orkla corn plaster with Salicylic acid | Experimental | Not described Receives: Combination Product: Orkla Corn Plaster with salicylic acid |
| Orkla corn protector without salicylic acid | Active comparator | Not described Receives: Device: Orkla Corn Protector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of improved subjects treated with Orkla Corn Plaster (with salicylic acid) at D28 compared to D0 (baseline)
Measured: 28 days
Secondary outcomes (16)
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)
Measured: 28 days
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.
Measured: 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.
Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.
Measured: 14 days, 28 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
Comparisons within the Orkla Corn Plaster group, and comparison between the two treatment groups Orkla Corn Plaster vs. Orkla Corn Protector.
Measured: Before and immediately after plaster application
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.
Measured: 14 days, 28 days, 3 months and 6 months
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.
Measured: Up to 6 months
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.
Measured: 14 days, 28 days, 3 months and 6 months
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.
Measured: 14 days, 28 days, 3 months and 6 months
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.
Measured: 14 days, 28 days
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.
Measured: 14 days, 28 days
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.
Measured: 28 days
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.
Measured: 28 days
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.
Measured: 28 days
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.
Measured: 28 days
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.
Measured: 28 days
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start21 Oct 2020
- Primary completion14 Jan 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CornsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orkla Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felix Lundin, Principal investigator, Carlanderska Hospital, Carlandersparken 1, 405 45 Göteborg, Sweden.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601259
- Sponsor's protocol ID
- OCI-001
- Status last verified
- Sep 2021
- First submitted
- 13 Oct 2020
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Open-labelled Investigation to Assess Performance and Safety of Orkla Corn Plaster
- ClinicalTrials.gov ID
- NCT04601259
- Acronym / sponsor ID
- OCI-001
- Conditions
- Corns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Orkla Care ABIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orkla corn plaster with Salicylic acid | Experimental | Combination Product: Orkla Corn Plaster with salicylic acid |
| Orkla corn protector without salicylic acid | Active comparator | Device: Orkla Corn Protector |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orkla Corn Plaster with salicylic acidEach 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. | Combination product | Orkla corn plaster with Salicylic acid |
| Orkla Corn ProtectorEach 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. | Device | Orkla corn protector without salicylic acid |
Primary outcome
Percentage of improved subjects treated with Orkla Corn Plaster (with salicylic acid) at D28 compared to D0 (baseline)
Time frame: 28 days
16 secondary outcomes
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
Percentage of improved subjects at D14, 3 and 6 months compared to baseline.
Time frame: 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
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
Resolution of corn at D14, D28, 3 and 6 months
Time frame: 14 days, 28 days, 3 months and 6 months
Subject reported resolution point of time (diary)
Time frame: Up to 6 months
Percentage of subjects with recurrence at D14, D28, 3 and 6 months
Time frame: 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
Usability questionnaire: Ease of application assessed via subject-reported question with a 5-point qualitative scale.
Time frame: 14 days, 28 days
Usability questionnaire: Adherence to the application site assessed via subject-reported question with a 5-point qualitative scale.
Time frame: 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
Subject treatment satisfaction questionnaire: Corn appearance improvement assessed via subject-reported question with a 5-point qualitative scale
Time frame: 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
Investigator treatment satisfaction questionnaire: Overall treatment satisfaction assessed via investigator-reported question with a 5-point qualitative scale
Time frame: 28 days
Investigator treatment satisfaction questionnaire: Corn appearance improvement assessed via investigator-reported questionnaire with a 5-point qualitative scale
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Corns
Active, not recruiting
Nutrient Profile and Muscle Protein Synthesis in Response to Corn Bread Made From Refined Versus Whole Grain Maize Flour
Effect of Food
Recruiting
Dietary Fibres on Gut Fermentation
Healthy Adult
Active, not recruiting
Glycemic Index of Sweet Corn
Glycemic Index
Recruiting
Pharmacokinetic (PK) Study of Phytochemicals in Whole Grains (WGs)- Corn
Healthy Adult Females, Healthy Adult Males
Active, not recruiting
Sweet Corn and Carotenoids
Carotenoids
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Lundin principal investigator
Carlanderska Hospital, Carlandersparken 1, 405 45 Göteborg, Sweden.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orkla Corn Plaster with salicylic acid and Orkla Corn Protector in people with Corns, run by Orkla Care AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of improved subjects treated with Orkla Corn Plaster (with salicylic acid) at D28 compared to D0 (baseline) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.