ErythemaNCT05742347
Skin Protectant Textile Efficacy Study for Managing Skin Fold Conditions
A study testing DriGo Skin Protectant Textile in people with Erythema and Maceration, run by Medline Industries at 1 site in United States.
Trial summary
This study will evaluate the efficacy of the DriGo skin protectant textile (SPT) to manage erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor associated with skin folds (henceforth together referred to as "skin fold conditions"). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Erythema, Maceration, Lesion Skin
- What is being tested?
- DriGo Skin Protectant Textile
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 26 Sep 2024
- 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.
- Individuals who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor.
- Individuals whose treatment plan permits assessment of the skin fold condition(s) for up to six days.
Who cannot join
- Individuals whose target area(s) are being managed with topical treatments such as antibiotics, antifungals, ointments including skin protectants, anti-itch products, anoperineal dressings or absorbent pads (eg, ARD®).
- Individuals with a known allergy or sensitivity to the ingredients in the SPT, such as the fabric or H2O2, as well as the tape that may be used to secure the SPT.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Skin Protectant Textile for the Management of Skin Fold Conditions
This study will evaluate the efficacy of the DriGo skin protectant textile (SPT) to manage erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor associated with skin folds (henceforth together referred to as "skin fold conditions"). Participants will be patients with skin fold conditions, which will be treated with the SPT. Healthcare providers will apply the SPT to the participants' target areas. A given participant can have up to two target areas enrolled in the study. An independent licensed clinician with experience in identifying and treating skin fold conditions, will use photographs of the skin folds and other skin-on-skin contact areas (henceforth referred to as "target area[s]") to assess the status of erythema, maceration, denudation, and satellite lesions in the target areas when the SPT is first applied (Day 0), and on Days 1, 3, and 5, during SPT changes. The Principal Investigator (PI) or qualified designee will take photographs of the target areas and assess moisture and odor in these areas. Participants will provide their impressions of pain, itching and burning in the target area(s) on the same days as the skin fold condition photography. In addition, the study will include feedback from the Health Care Providers (HCPs) about the SPT and overall experience of the participants with the SPT.
- Conditions
- Erythema, Maceration, Lesion Skin, Skin Folds
- Being tested
- DriGo Skin Protectant Textile
- Medical subject headings
- Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DriGo Skin Protectant TextileDevice
All participants in this study will have the DriGo skin protectant textile applied to their skin fold condition. Erythema, denudation, maceration, odor, and moisture will be assessed following application of the SPT.
| Study group | Role | What they receive |
|---|---|---|
| DriGo SPT | Experimental | All participants will have the DriGo skin protectant textile applied to their skin fold condition. Receives: Device: DriGo Skin Protectant Textile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema
The efficacy of the SPT to improve skinfold condition of erythema over three days of treatment were assessed by third party clinicians using a 5-point Likert scales, with "0" being least severe and "4" being most severe. Data is reported as the mean and standard deviation on the scale for each timepoint.
Measured: day 0, day 1, day 3
Maceration
The efficacy of the SPT to improve skinfold conditions of maceration over three days of treatment were assessed by third party clinician using a 5-point Likert scales, with "0" being least severe and "4" being most severe. Data is reported as the mean and standard deviation values from the scale for each timepoint measured.
Measured: day 0, day 1, day 3.
Denudation
The efficacy of the SPT to improve skinfold conditions denudation were assessed over 3 days by a third party clinician using a 5-point Likert scales, with "0" being least severe and "4" being most severe. Data is reported as the mean and standard deviation value on the scale for each timepoint measured.
Measured: day 0, day 1, and day 3.
Satellite Lesions
The efficacy of the SPT to improve skinfold conditions of satellite lesions were assessed by a third party clinician as absent or present each day over 5 days. Results for present lesions detected presented below. Data is reported as the percentage of participants identified with any satellite lesions.
Measured: 5 days
Odor
The efficacy of the SPT to improve skinfold conditions of odor over five days of treatment was assessed by a third party clinician as absent or present with values for present noted below. Data is presented as the percentage of participants identified with any odor at the target area for each timepoint measured.
Measured: Day 0, day 1, day 3 and day 5
Secondary outcomes (6)
Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control.
survey responses for moisture in the target area(s) on Day 0, and on Days 1, 3, and 5, during SPT changes, third party clinicians assessed the moisture as either abscent/scant or small/moderate. All other patients were coded as not able to detect. Data is presented as the percentage of participants with abscent/scant moisture at each timepoint and the percentage of participants with small/moderate moisture at each timepoint.
Measured: Day 0, day 1, day 3, and day 5
Assessing Patient Reported Outcomes of Discomfort (Pain, Itching, Burning) Before Dressing Change
Assessing Patient reported outcomes before the dressing change - VAS score 0-100 mm with 0 being the least amount of pain and 100 being the most painful.
Measured: day 0, day 1, day 3
Patient Report of Pain Itching or Burning After Dressing Change Day 0, Day 1, and Day 3
Assessing patient reported outcomes of discomfort (Pain, Itching, or Burning) experienced after the dressing change Patient Reported Outcomes: VAS score 0-100 mm with 0 being the least painful and 100 being the most painful
Measured: day 0, day 1, day3
Did the Product Reduce Your Discomfort Assessed at Discharge Day 5
Summary Statistics of: The dressing significantly reduced discomfort (Pain, Itching, and Burning) in the skin-on-skin contact area (target area) at Day 5 with 0 being not at all and 100 being absolutely yes it helped reduce my discomfort.
Measured: Day 5
The Product Dressing Was Comfortable to Wear
Summary Statistics of: The dressing was comfortable to wear at at Day 5. VAS score 0-100 mm with 0 being not at all comfortable and 100 being the most comfortable.
Measured: Day 5
Summary Statistics of HCP - HCP Reported Ease of Use: VAS Score 0-100 mm
Summary Statistics of HCP: Instructions for application of the skin protectant textile (SPT) were easy to understand. Health care practioniers (HCPs) answered a series of questions regarding the instructions for the product. Each question answered on a scale of 0-100 with 0 being negative/difficult/not likely to reccomend and 100 being positive/easy to use/likely to reccomend to others. Data is reported as the mean value for the question asked based on the scale value of 0-100. These questions were only asked of the HCP at the end of the study on day 5.
Measured: End of the study on day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Jul 2022
- Primary completion12 Aug 2024
- Study completion26 Sep 2024
Why it stopped: The site sent a formal notification letter of their decision to terminate the study.
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 ErythemaStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A total of 46 participants were enrolled in the study -- many contributed more than one target area for a total of 82 total target areas for the study.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medline Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742347
- Sponsor's protocol ID
- MED-2021-DIV80-006
- Status last verified
- May 2025
- First submitted
- 10 Feb 2023
- Last updated
- 21 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Skin Protectant Textile for the Management of Skin Fold Conditions
- ClinicalTrials.gov ID
- NCT05742347
- Acronym / sponsor ID
- MED-2021-DIV80-006
- Conditions
- Erythema, Maceration, Lesion Skin, Skin Folds
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The site sent a formal notification letter of their decision to terminate the study.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Medline IndustriesIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 24 Feb 2023 (actual)
- Results
- Posted 21 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy of the DriGo skin protectant textile (SPT) to manage erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor associated with skin folds (henceforth together referred to as "skin fold conditions"). Participants will be patients with skin fold conditions, which will be treated with the SPT. Healthcare providers will apply the SPT to the participants' target areas. A given participant can have up to two target areas enrolled in the study. An independent licensed clinician with experience in identifying and treating skin fold conditions, will use photographs of the skin folds and other skin-on-skin contact areas (henceforth referred to as "target area[s]") to assess the status of erythema, maceration, denudation, and satellite lesions in the target areas when the SPT is first applied (Day 0), and on Days 1, 3, and 5, during SPT changes. The Principal Investigator (PI) or qualified designee will take photographs of the target areas and assess moisture and odor in these areas. Participants will provide their impressions of pain, itching and burning in the target area(s) on the same days as the skin fold condition photography. In addition, the study will include feedback from the Health Care Providers (HCPs) about the SPT and overall experience of the participants with the SPT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A total of 46 participants were enrolled in the study -- many contributed more than one target area for a total of 82 total target areas for the study.
| Arm | Type | Receives |
|---|---|---|
| DriGo SPT | Experimental | Device: DriGo Skin Protectant TextileAll participants will have the DriGo skin protectant textile applied to their skin fold condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals ≥ 18 years of age.
- Individuals who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor.
- Individuals whose treatment plan permits assessment of the skin fold condition(s) for up to six days.
Key exclusion criteria (2 listed)
- Individuals whose target area(s) are being managed with topical treatments such as antibiotics, antifungals, ointments including skin protectants, anti-itch products, anoperineal dressings or absorbent pads (eg, ARD®).
- Individuals with a known allergy or sensitivity to the ingredients in the SPT, such as the fabric or H2O2, as well as the tape that may be used to secure the SPT.
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 |
|---|---|---|
| DriGo Skin Protectant TextileAll participants in this study will have the DriGo skin protectant textile applied to their skin fold condition. Erythema, denudation, maceration, odor, and moisture will be assessed following application of the SPT. | Device | DriGo SPT |
Primary outcome
Erythema
Time frame: day 0, day 1, day 3
The efficacy of the SPT to improve skinfold condition of erythema over three days of treatment were assessed by third party clinicians using a 5-point Likert scales, with "0" being least severe and "4" being most severe. Data is reported as the mean and standard deviation on the scale for each timepoint.
Maceration
Time frame: day 0, day 1, day 3.
The efficacy of the SPT to improve skinfold conditions of maceration over three days of treatment were assessed by third party clinician using a 5-point Likert scales, with "0" being least severe and "4" being most severe. Data is reported as the mean and standard deviation values from the scale for each timepoint measured.
Denudation
Time frame: day 0, day 1, and day 3.
The efficacy of the SPT to improve skinfold conditions denudation were assessed over 3 days by a third party clinician using a 5-point Likert scales, with "0" being least severe and "4" being most severe. Data is reported as the mean and standard deviation value on the scale for each timepoint measured.
Satellite Lesions
Time frame: 5 days
The efficacy of the SPT to improve skinfold conditions of satellite lesions were assessed by a third party clinician as absent or present each day over 5 days. Results for present lesions detected presented below. Data is reported as the percentage of participants identified with any satellite lesions.
Odor
Time frame: Day 0, day 1, day 3 and day 5
The efficacy of the SPT to improve skinfold conditions of odor over five days of treatment was assessed by a third party clinician as absent or present with values for present noted below. Data is presented as the percentage of participants identified with any odor at the target area for each timepoint measured.
6 secondary outcomes
Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control.
Time frame: Day 0, day 1, day 3, and day 5
Assessing Patient Reported Outcomes of Discomfort (Pain, Itching, Burning) Before Dressing Change
Time frame: day 0, day 1, day 3
Patient Report of Pain Itching or Burning After Dressing Change Day 0, Day 1, and Day 3
Time frame: day 0, day 1, day3
Did the Product Reduce Your Discomfort Assessed at Discharge Day 5
Time frame: Day 5
The Product Dressing Was Comfortable to Wear
Time frame: Day 5
Summary Statistics of HCP - HCP Reported Ease of Use: VAS Score 0-100 mm
Time frame: End of the study on day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DriGo Skin Protectant Textile in people with Erythema and Maceration, 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 21 May 2025. 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 21 May 2025). 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?
Erythema (time frame: day 0, day 1, day 3). The study lists 5 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 21 May 2025.