Title
A Clinical Investigation to Evaluate The Orkla Corn Plaster
A Prospective, Randomized, Controlled, Open-labelled Investigation to Assess Performance and Safety of Orkla Corn Plaster
Phase
N/ALead Sponsor
Orkla HealthStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
CornsIntervention/Treatment
Orkla Corn Plaster with salicylic acid ...Study Participants
55This 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.
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.
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.
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
