Clinical trial NCT04695873: A 3 Day In-use Assessment of the Scholl Corn Foam Cushions on Pain Levels Associated With Heloma Durum.
Official title: An Open-label, Randomised, Parallel-group, No-treatment Control Investigation to Determine the Effect of the Scholl Corn Foam Cushions, on Pain Levels When Used on Heloma Durum (Hard Corns) on the Dorsal Digital (Top of the Toe) and the Plantar Weight Bearing Areas (Ball of Foot) of the Feet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heloma Durum
Keywords: VAS Pain Assessment
Symptomatic Pain Relief
Lead sponsor: Reckitt Benckiser Healthcare (UK) Limited
Sponsor class: INDUSTRY
Collaborators: name: O4 Research
First posted: 2021-01-05
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An open label, randomized parallel group, no treatment control investigation.
Primary purpose: TREATMENT

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 participants suffering from painful Heloma Durum over a 72-hour at home in-use period compared to a no-treatment control group.

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 eligibility and collection of baseline data, including baseline pain scores using the Visual Analogue Scale (VAS), medical history, demographics, and baseline Patient Reported Outcomes (PRO) assessments. Baseline data collected will be assessed to confirm eligibility before randomisation, first product application (treatment group only), initial pain (VAS) Participant Perceived Questionnaires (PPQ) and PRO assessments. During the at home in-use period, those participants randomised to the treatment group will reapply the product daily, complete pain assessments using the VAS (morning and evening), PPQs and PROs (Day 3 evening only). For participants randomised to the no-treatment group, they will complete pain assessments using the VAS (morning and evening) and PROs (Day 3 evening). All participants will continuously record Adverse Events (AE) and changes to concomitant medication throughout this period. During the follow up phone call, the participants will be contacted to establish any further AEs and/or changes to concomitant medication, additionally any queries related to diary entries will be made during this phone call. Participants will not need to return to the site unless advised to do so by the Principal Investigator (PI) or delegate.

After completion of the investigation, the Investigator will make an Assessment of Tolerance for each subject based on their pain scores (VAS), PPQ responses and AEs reported.

Eligibility criteria: Inclusion Criteria:

1. Participant has provided written informed consent.
2. Male or female participants aged: ≥ 18 and \<70 years.
3. 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.
4. A baseline VAS score of ≥20 units and ≤75 units when measured on a VAS of 0-100.
5. Able to attend the investigation centre on the predefined day(s).
6. 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).
7. Is willing and capable of adhering to the investigational requirements.

Exclusion Criteria:

1. 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.
2. Individuals who have received any of the following treatment of their Heloma Durum:

   1. Conservative treatments (e.g. cushioning) within the last 2 days
   2. Chemical treatments (e.g. Salicylic Acid plaster) within the last 2 weeks
   3. Physical treatments (e.g. Heloma Durum debridement, including home debridement) within the last 6 weeks
3. 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.
4. Significant foot deformities or inflammation (e.g. bunions, heel spurs, gout etc.).
5. Concurrent participation in another interventional clinical study/investigation, or participation within 30 days before Day 1 of this investigation.
6. Active infections of the foot or skin of the foot.
7. 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).
8. Participants who regularly use painkillers for ongoing conditions.
9. Participants who have taken over-the-counter painkillers within the last 2 days prior to screening.
10. Participants who are taking/or have taken prescription painkillers in the last 2 weeks prior to screening.
11. 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.
12. Any individuals with diabetes or poor blood circulation.
13. 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).
14. Any Heloma Durum where the surrounding skin is inflamed or broken.
15. 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.
16. Participants who are employees at the site or are a partner or first-degree relative of the Investigator.
17. Participants who fail to satisfy the Investigator of fitness to participate for any other reason

Primary outcomes:
measure: Overall pain relief
timeFrame: Days 1-3
Secondary outcomes:
measure: Immediate pain relief
timeFrame: 25 minutes
measure: Specific Timepoint pain relief
timeFrame: Days 1-3
measure: Percentage of participants experiencing a 25% pain reduction
timeFrame: Days 1-3
measure: Consumer Acceptability
timeFrame: Days 1-3
measure: Safety and Tolerability
timeFrame: Days 1-3
measure: Foot Health Improvement
timeFrame: Days 1-3
measure: Quality of Life Improvement
timeFrame: Days 1-3
Other outcomes:
measure: Impact of Heloma Durum on work productivity and activity
timeFrame: Day 1
Locations:
city: Galway
country: Ireland
facility: Podiatry Services, West Community Services
Study officials:
name: David Watterson
role: PRINCIPAL_INVESTIGATOR
name: Moneeb Saddiq
role: STUDY_DIRECTOR
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