A 3 Day In-use Assessment of the Scholl Corn Foam Cushions on Pain Levels Associated With Heloma … (NCT04695873) | Clinical Trial Compass
CompletedNot Applicable
A 3 Day In-use Assessment of the Scholl Corn Foam Cushions on Pain Levels Associated With Heloma Durum.
Ireland96 participantsStarted 2021-06-16
Plain-language 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 participants suffering from painful Heloma Durum over a 72-hour at home in-use period compared to a no-treatment control group.
Who can participate
Age range18 Years – 69 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
✕. Concurrent participation in another interventional clinical study/investigation, or participation within 30 days before Day 1 of this investigation.