A Clinical Investigation to Evaluate The Orkla Corn Plaster

NCT ID: NCT04601259

Last Updated: 2021-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-21

Study Completion Date

2021-06-10

Brief Summary

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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.

Detailed Description

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Conditions

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Corns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Orkla corn plaster with Salicylic acid

Group Type EXPERIMENTAL

Orkla Corn Plaster with salicylic acid

Intervention Type COMBINATION_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 protector without salicylic acid

Group Type ACTIVE_COMPARATOR

Orkla Corn Protector

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orkla Care AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Felix Lundin

Role: PRINCIPAL_INVESTIGATOR

Carlanderska Hospital, Carlandersparken 1, 405 45 Göteborg, Sweden.

Locations

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Carlanderska Hospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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OCI-001

Identifier Type: -

Identifier Source: org_study_id

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