A Clinical Investigation to Evaluate The Orkla Corn Plaster

Orkla Care

Status: Completed

Conditions: Corns

Treatments: Combination Product: Orkla Corn Plaster with salicylic acid; Device: Orkla Corn Protector

Study type: Interventional

Funder types: Industry

Identifiers

NCT04601259

OCI-001

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Orkla corn plaster with Salicylic acid

Experimental group

Treatment:

Combination Product: Orkla Corn Plaster with salicylic acid

Orkla corn protector without salicylic acid

Active Comparator group

Treatment:

Device: Orkla Corn Protector