NCT04601259

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

October 21, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

October 13, 2020

Last Update Submit

September 8, 2021

Conditions

Corns

Outcome Measures

Primary Outcomes (1)

  • Percentage of improved subjects treated with Orkla Corn Plaster (with salicylic acid) at D28 compared to D0 (baseline)

    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)

    28 days

  • Percentage of improved subjects at D14, 3 and 6 months compared to baseline.

    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.

    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

    Before and immediately after plaster application

  • Resolution of corn at D14, D28, 3 and 6 months

    14 days, 28 days, 3 months and 6 months

  • +11 more secondary outcomes

Other Outcomes (1)

  • 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.

    6 months

Study Arms (2)

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

Interventions

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 plaster with Salicylic acid
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.

Orkla corn protector without salicylic acid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carlanderska Hospital

Gothenburg, 405 45, Sweden

Location

MeSH Terms

Conditions

Callosities

Interventions

Salicylic Acid

Condition Hierarchy (Ancestors)

KeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • Felix Lundin

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 23, 2020

Study Start

October 21, 2020

Primary Completion

January 14, 2021

Study Completion

June 10, 2021

Last Updated

September 9, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)