Status:
COMPLETED
A 3 Day In-use Assessment of the Scholl Corn Foam Cushions on Pain Levels Associated With Heloma Durum.
Lead Sponsor:
Reckitt Benckiser Healthcare (UK) Limited
Collaborating Sponsors:
O4 Research
Conditions:
Heloma Durum
Eligibility:
All Genders
18-69 years
Phase:
NA
Brief Summary
This is an open-label, single-centre, parallel-group clinical investigation to evaluate the symptomatic pain relief, consumer acceptability and in-use tolerability of the Scholl Corn Foam Cushion in p...
Detailed Description
The investigation design will include an enrolment and randomisation visit followed by an at home in-use period and a final follow up phone call. The enrolment visit will include confirmation of eligi...
Eligibility Criteria
Inclusion
- Participant has provided written informed consent.
- Male or female participants aged: ≥ 18 and \<70 years.
- Otherwise healthy individual suffering from a single painful Heloma Durum on the dorsal digital or the plantar weight bearing area of the foot (or feet) as assessed by the Investigator or suitable delegate.
- A baseline VAS score of ≥20 units and ≤75 units when measured on a VAS of 0-100.
- Able to attend the investigation centre on the predefined day(s).
- Owns or has access to a device with internet connectivity and is willing to download an investigation application and participate in the collection of patient-reported data (criterion only applicable for the use of electronic patient reported outcomes (ePRO) diary).
- Is willing and capable of adhering to the investigational requirements.
Exclusion
- Individuals who have known allergies or sensitivities to latex, or any other ingredients of the product, which in the opinion of the Investigator is considered clinically relevant.
- Individuals who have received any of the following treatment of their Heloma Durum:
- Conservative treatments (e.g. cushioning) within the last 2 days
- Chemical treatments (e.g. Salicylic Acid plaster) within the last 2 weeks
- Physical treatments (e.g. Heloma Durum debridement, including home debridement) within the last 6 weeks
- Participants who, in the opinion of the Principal Investigator, have any unhealed skin at or surrounding the Heloma Durum as a result of any treatments used by the individual.
- Significant foot deformities or inflammation (e.g. bunions, heel spurs, gout etc.).
- Concurrent participation in another interventional clinical study/investigation, or participation within 30 days before Day 1 of this investigation.
- Active infections of the foot or skin of the foot.
- Those who are pregnant, attempting to become pregnant, or believe they may be pregnant or have given birth within the last 6 months (self-reported).
- Participants who regularly use painkillers for ongoing conditions.
- Participants who have taken over-the-counter painkillers within the last 2 days prior to screening.
- Participants who are taking/or have taken prescription painkillers in the last 2 weeks prior to screening.
- Participants who are unwilling to wear the same footwear throughout the investigation (footwear is defined as structured and enclosed shoes or trainers with a method of closure e.g. laces and a heel of less than 3 cm. Consistent wearing of socks/tights should be maintained throughout the investigation) for the duration of the investigation.
- Any individuals with diabetes or poor blood circulation.
- Any other callosity that is not identified as a Heloma Durum by a healthcare professional (i.e. soft corn, neurovascular corn, seed corn, fibrous corns).
- Any Heloma Durum where the surrounding skin is inflamed or broken.
- Any other features identified within the screening process that in the opinion of the Investigator will impact the safety or wellbeing of the participant or affect the outcome of the investigation.
- Participants who are employees at the site or are a partner or first-degree relative of the Investigator.
- Participants who fail to satisfy the Investigator of fitness to participate for any other reason
Key Trial Info
Start Date :
June 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2021
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04695873
Start Date
June 16 2021
End Date
October 11 2021
Last Update
December 27 2021
Active Locations (1)
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1
Podiatry Services, West Community Services
Galway, Ireland, H91N973