Skin Hydration in Healthy VolunteersNCT05756348
Durability of Two Skin Barrier Protectants (SBP)
A study testing Marathon® XL No Sting Cyanoacrylate Skin Protectant and 3M™ Cavilon™ Advanced Skin Protectant in people with Skin Hydration in Healthy Volunteers, run by Medline Industries at 1 site in United States.
Trial summary
The current study will evaluate the duration of wear and durability of two commercially available SBPs: Medline Marathon® XL (extra long) No Sting Cyanoacrylate Skin Protectant (henceforth referred to as "Marathon®") and 3M™ Cavilon™ Advanced Skin Protectant (henceforth referred to as "Cavilon™"). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Hydration in Healthy Volunteers
- What is being tested?
- Marathon® XL No Sting Cyanoacrylate Skin Protectant and 3M™ Cavilon™ Advanced Skin Protectant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2022to 22 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals ≥ 18 years of age
Who cannot join
- Individuals have skin conditions that might interfere with Corneometer® measurements, including rash, irritation, sunburn, tattoo, birthmark, any other dermal irregularities on the left or right volar forearm or inner elbow.
- Individuals have excessive hair on the left or right volar forearm or inner elbow as determined by study personnel.
- Individuals have a self-reported allergy/sensitivity to ingredients present in either of the SBPs, components of the soap used for bathing, or the exam gloves and non-toxic marker used in the study.
- Individuals are pregnant.
- Individuals whose self-reported activities may affect friction on one arm more than the other (eg, sports like tennis or holding a baby where one arm is used more routinely than the other).
- Individuals who are able to identify the manufacturer of the SBPs included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Skin Protection Characteristics of Two Commercially Available Skin Barrier Protectants
The current study will evaluate the duration of wear and durability of two commercially available SBPs: Medline Marathon® XL (extra long) No Sting Cyanoacrylate Skin Protectant (henceforth referred to as "Marathon®") and 3M™ Cavilon™ Advanced Skin Protectant (henceforth referred to as "Cavilon™").
Read the detailed description
Completion of informed consent and participant screening will be followed by a washout period of minimum 18 hours (wherein participants will be asked to avoid application of cleansers, lotions, or perfumes to both forearms and inner elbows) prior to the first visit (Visit 1) of the study. During Visit 1, study personnel will confirm that the washout period has been successfully completed. Participants will wash their forearms and inner elbows with a standardized soap and dry them using paper towels for each arm. After the participants' forearms and inner elbows have fully dried, study personnel will use a Corneometer® (which measures skin hydration) to record baseline measurements of the skin within 2-inch x 2-inch squares (starting about two inches above the wrist) marked with a non-toxic marker on the volar forearms and inner elbows of the participants. Thereafter, participants will be randomized to the two SBPs, Marathon® or Cavilon™ (designated SBP). The designated SBP will be applied to the volar forearm and inner elbow "test areas" on the participant's dominant arm (as determined by the participant). The other SBP will be applied to the volar forearm and inner elbow "test areas" on the participant's non-dominant arm. A distinct area of each volar forearm will be used as an "untreated control area". Corneometer® measurements will be taken again on the same day after the SBPs have been left to dry for at least one minute or have fully dried. Thereafter, subsequent measurements will be taken daily over a seven-day period with a two-day break over the weekend. Each participant will commence the study on Monday or Tuesday. This will permit daily readings for the first 72 hours, which is the more important window to evaluate SBP wear time. There will be a two-day break in measurements over the weekend, after which Corneometer® measurements will be taken either on Monday, or Monday and Tuesday, depending on the participants' start date. Participants will be allowed to bathe their arms using a standardized soap provided by the study personnel but will be asked to minimize scrubbing and any other abrasion of the volar forearms and inner elbows. In addition, participants will be instructed not to engage in activities, for eg, sports (eg, tennis) or holding a baby that may cause significant abrasion on one arm and not the other. On the last visit of the study (Visit 6), study personnel will take the last set of Corneometer® measurements. In addition, participants will also complete surveys regarding their experience with the SBPs on specific days during study participation.
The Corneometer® measurements will help determine the presence of the SBPs and their deterioration over time. Skin treated with the SBPs will typically have lower readings than untreated skin. As the SBPs break down, the corresponding readings are expected to rise.
- Conditions
- Skin Hydration in Healthy Volunteers
- Being tested
- Marathon® XL No Sting Cyanoacrylate Skin Protectant and 3M™ Cavilon™ Advanced Skin Protectant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marathon® XL No Sting Cyanoacrylate Skin Protectant and 3M™ Cavilon™ Advanced Skin ProtectantDevice
All participants will receive both device interventions listed above.
| Study group | Role | What they receive |
|---|---|---|
| receives both product | Other | all participants receive both products under evaluation. Receives: Device: Marathon® XL No Sting Cyanoacrylate Skin Protectant and 3M™ Cavilon™ Advanced Skin Protectant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration
To evaluate the duration of wear of Marathon® and Cavilon™ using the Corneometer® CM (capacitance method) 825 taking measurements of the skin (in Arbitrary Units) with the skin protectant applied at various time points compared to the skin control site without skin protectant at the same time points.
Measured: 7 Days - Baseline + 6 visits = 7
Durability
To evaluate the durability of Marathon® and Cavilon™ using the Corneometer® CM 825 taking measurements of the skin (in Arbitrary Units) in the inner elbow location with the skin protectant applied at various time points compared to the skin control site without skin protectant at the same time points.
Measured: 7 Days - Baseline + 6 visits = 7
Secondary outcomes (3)
Participant Feedback 2
To collect information on the participant experience with the two SBPs (Skin Barrier Protectants) using survey results (5 point scale from very comfortable to very uncomfortable). This question was on assessed at visit one.
Measured: 1 day
Participant Feedback
To collect information on the participant experience with the two SBPs using survey results (yes/no questions). This measurement collected on visit thee and visit six.
Measured: 2 Days
Participant Feedback - Product Preference
Collect participant feedback on which arm is it easier to determine the skin barrier protectant is present?
Measured: 7 Days - Baseline + 6 visits = 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start6 Oct 2022
- Primary completion22 Nov 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin Hydration in Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medline Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julie Miller, Principal investigator, Medline Industries, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756348
- Sponsor's protocol ID
- MED-2022-DIV71-003
- Status last verified
- Aug 2023
- First submitted
- 19 Oct 2022
- Last updated
- 20 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Skin Protection Characteristics of Two Commercially Available Skin Barrier Protectants
- ClinicalTrials.gov ID
- NCT05756348
- Acronym / sponsor ID
- MED-2022-DIV71-003
- Conditions
- Skin Hydration in Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Medline IndustriesIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Posted 20 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study will evaluate the duration of wear and durability of two commercially available SBPs: Medline Marathon® XL (extra long) No Sting Cyanoacrylate Skin Protectant (henceforth referred to as "Marathon®") and 3M™ Cavilon™ Advanced Skin Protectant (henceforth referred to as "Cavilon™").
Detailed description
Completion of informed consent and participant screening will be followed by a washout period of minimum 18 hours (wherein participants will be asked to avoid application of cleansers, lotions, or perfumes to both forearms and inner elbows) prior to the first visit (Visit 1) of the study. During Visit 1, study personnel will confirm that the washout period has been successfully completed. Participants will wash their forearms and inner elbows with a standardized soap and dry them using paper towels for each arm. After the participants' forearms and inner elbows have fully dried, study personnel will use a Corneometer® (which measures skin hydration) to record baseline measurements of the skin within 2-inch x 2-inch squares (starting about two inches above the wrist) marked with a non-toxic marker on the volar forearms and inner elbows of the participants. Thereafter, participants will be randomized to the two SBPs, Marathon® or Cavilon™ (designated SBP). The designated SBP will be applied to the volar forearm and inner elbow "test areas" on the participant's dominant arm (as determined by the participant). The other SBP will be applied to the volar forearm and inner elbow "test areas" on the participant's non-dominant arm. A distinct area of each volar forearm will be used as an "untreated control area". Corneometer® measurements will be taken again on the same day after the SBPs have been left to dry for at least one minute or have fully dried. Thereafter, subsequent measurements will be taken daily over a seven-day period with a two-day break over the weekend. Each participant will commence the study on Monday or Tuesday. This will permit daily readings for the first 72 hours, which is the more important window to evaluate SBP wear time. There will be a two-day break in measurements over the weekend, after which Corneometer® measurements will be taken either on Monday, or Monday and Tuesday, depending on the participants' start date. Participants will be allowed to bathe their arms using a standardized soap provided by the study personnel but will be asked to minimize scrubbing and any other abrasion of the volar forearms and inner elbows. In addition, participants will be instructed not to engage in activities, for eg, sports (eg, tennis) or holding a baby that may cause significant abrasion on one arm and not the other. On the last visit of the study (Visit 6), study personnel will take the last set of Corneometer® measurements. In addition, participants will also complete surveys regarding their experience with the SBPs on specific days during study participation.
The Corneometer® measurements will help determine the presence of the SBPs and their deterioration over time. Skin treated with the SBPs will typically have lower readings than untreated skin. As the SBPs break down, the corresponding readings are expected to rise.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| receives both product | Other | Device: Marathon® XL No Sting Cyanoacrylate Skin Protectant and 3M™ Cavilon™ Advanced Skin Protectantall participants receive both products under evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals ≥ 18 years of age
Key exclusion criteria (6 listed)
- Individuals have skin conditions that might interfere with Corneometer® measurements, including rash, irritation, sunburn, tattoo, birthmark, any other dermal irregularities on the left or right volar forearm or inner elbow.
- Individuals have excessive hair on the left or right volar forearm or inner elbow as determined by study personnel.
- Individuals have a self-reported allergy/sensitivity to ingredients present in either of the SBPs, components of the soap used for bathing, or the exam gloves and non-toxic marker used in the study.
- Individuals are pregnant.
- Individuals whose self-reported activities may affect friction on one arm more than the other (eg, sports like tennis or holding a baby where one arm is used more routinely than the other).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marathon® XL No Sting Cyanoacrylate Skin Protectant and 3M™ Cavilon™ Advanced Skin ProtectantAll participants will receive both device interventions listed above. | Device | receives both product |
Primary outcome
Duration
Time frame: 7 Days - Baseline + 6 visits = 7
To evaluate the duration of wear of Marathon® and Cavilon™ using the Corneometer® CM (capacitance method) 825 taking measurements of the skin (in Arbitrary Units) with the skin protectant applied at various time points compared to the skin control site without skin protectant at the same time points.
Durability
Time frame: 7 Days - Baseline + 6 visits = 7
To evaluate the durability of Marathon® and Cavilon™ using the Corneometer® CM 825 taking measurements of the skin (in Arbitrary Units) in the inner elbow location with the skin protectant applied at various time points compared to the skin control site without skin protectant at the same time points.
3 secondary outcomes
Participant Feedback 2
Time frame: 1 day
Participant Feedback
Time frame: 2 Days
Participant Feedback - Product Preference
Time frame: 7 Days - Baseline + 6 visits = 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Skin Hydration in Healthy Volunteers
Recruiting
Clinical Investigation on a Polynucleotide-based Device Used to Improve Skin Hydration
Aesthetic Improvement of the Skin, Skin Hydration in Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Miller principal investigator
Medline Industries, LP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marathon® XL No Sting Cyanoacrylate Skin Protectant and 3M™ Cavilon™ Advanced Skin Protectant in people with Skin Hydration in Healthy Volunteers, run by Medline Industries at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration (time frame: 7 Days - Baseline + 6 visits = 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.