Skin (FLACC Scores of Test Subjects) After Tape RemovalNCT03470012
Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects
A study testing Multi-Purpose Gentle Tape in people with Skin (FLACC Scores of Test Subjects) After Tape Removal, run by Solventum US LLC at 1 site in United States.
Trial summary
The objective of this study is to determine the relative gentleness of a new medical tape. Read more about this study
- Who is it for?
- Ages 6 months to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin (FLACC Scores of Test Subjects) After Tape Removal
- What is being tested?
- Multi-Purpose Gentle Tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2018to 20 Mar 2018
- 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 6 months to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- Who are known to be developmentally delayed
- Who have any known allergy or sensitivity to tapes
- Who have sunburn, skin infection or scars, moles, or other blemishes on the back that would obscure grading of the test site
- Who have had any exposure to other topical medications, creams, powders, or ointments on the test sites 24 hours prior to the start of the study
- Who have had a strep infection within the 2 weeks prior to the start of the study
- Who have a history of uncontrolled diabetes, psoriasis, any active dermatitis, or recent history of dermatitis or skin reactions
- Has participated in any study in the last 2 weeks, or are currently participating in another study, or are scheduled to participate in another study during this study period.
- Has any other skin disorders that, in the opinion of the investigator, will interfere with the study results or will increase undue risk for the child.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to determine the relative gentleness of a new medical tape.
Read the detailed description
The objective of this study is to determine the relative gentleness of a new medical tape. A three-prong multidimensional evaluation consisting of expert grader, subject discomfort assessment, and laboratory assessments was used. One pre-study visit took place up to 7 days prior to the start of the study. The study was conducted over two days with one tape sample applied and removed. Assessments were taken on the final day. This was to mimic a normal tape application in health care practice.
- Being tested
- Multi-Purpose Gentle Tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Purpose Gentle TapeDevice
The Multi-Purpose Gentle Tape is a general purpose medical adhesive tape for medical applications used primarily to secure dressings, lightweight tubing, and devices to skin.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Investigational tape Receives: Device: Multi-Purpose Gentle Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Face, Legs, Activity, Cry, Consolability (FLACC) Score.
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is a measurement used to assess pain for children Participants between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. Lower values represent lessening pain on the scale. At the 24 hour visit , a baseline FLACC score was recorded with the tape still in place. The tape was then removed and a FLACC score was recorded after removal. The reported value is the difference between FLACC after removal and FLACC at baseline.
Measured: 24 Hours after initial tape application and after tape removal. Change in FLACC score between the time of tape removal and baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start16 Jan 2018
- Primary completion23 Jan 2018
- Study completion20 Mar 2018
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 (FLACC Scores of Test Subjects) After Tape RemovalStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Gary L Grove, PhD, Principal investigator, Study Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470012
- Sponsor's protocol ID
- 05-014050
- Status last verified
- Sep 2024
- First submitted
- 13 Mar 2018
- Last updated
- 2 Oct 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 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects
- ClinicalTrials.gov ID
- NCT03470012
- Acronym / sponsor ID
- 05-014050
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 23 Jan 2018 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Posted 20 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the relative gentleness of a new medical tape.
Detailed description
The objective of this study is to determine the relative gentleness of a new medical tape. A three-prong multidimensional evaluation consisting of expert grader, subject discomfort assessment, and laboratory assessments was used. One pre-study visit took place up to 7 days prior to the start of the study. The study was conducted over two days with one tape sample applied and removed. Assessments were taken on the final day. This was to mimic a normal tape application in health care practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Multi-Purpose Gentle TapeInvestigational tape |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Who are known to be developmentally delayed
- Who have any known allergy or sensitivity to tapes
- Who have sunburn, skin infection or scars, moles, or other blemishes on the back that would obscure grading of the test site
- Who have had any exposure to other topical medications, creams, powders, or ointments on the test sites 24 hours prior to the start of the study
- Who have had a strep infection within the 2 weeks prior to the start of the study
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 |
|---|---|---|
| Multi-Purpose Gentle TapeThe Multi-Purpose Gentle Tape is a general purpose medical adhesive tape for medical applications used primarily to secure dressings, lightweight tubing, and devices to skin. | Device | Treatment Arm |
Primary outcome
The Face, Legs, Activity, Cry, Consolability (FLACC) Score.
Time frame: 24 Hours after initial tape application and after tape removal. Change in FLACC score between the time of tape removal and baseline.
The Face, Legs, Activity, Cry, Consolability (FLACC) scale is a measurement used to assess pain for children Participants between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. Lower values represent lessening pain on the scale. At the 24 hour visit , a baseline FLACC score was recorded with the tape still in place. The tape was then removed and a FLACC score was recorded after removal. The reported value is the difference between FLACC after removal and FLACC at baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Gary L Grove, PhD principal investigator
Study Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Purpose Gentle Tape in people with Skin (FLACC Scores of Test Subjects) After Tape Removal, run by Solventum US LLC 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 0 inclusion and 8 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 2 Oct 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 Jul 2020). 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?
The Face, Legs, Activity, Cry, Consolability (FLACC) Score. (time frame: 24 Hours after initial tape application and after tape removal. Change in FLACC score between the time of tape removal and baseline.). 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 2 Oct 2024.