Diaper DermatitisPhase 4NCT04101890
The Healthy Baby Bottoms Study
A Phase 4 study testing Diaper care with Theraworx in people with Diaper Dermatitis, run by Linda Fu at 1 site in United States.
Trial summary
Diaper dermatitis is one of the most common dermatologic diseases affecting infants and children. The incidence is highest among those 9-12 months old and it has been reported to affect 7-50% of infants in the US. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diaper Dermatitis
- What is being tested?
- Diaper care with Theraworx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2020to 2 Jan 2021
- Phase
- Phase 4
- 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
- Read English at the 8th grade level
- Have reliable access to email for 7 weeks
- Complete the first online survey within 24 hours of the request
- Custodial guardian of an infant between the ages of 1-12 months old living with him/her, wearing diapers, and has had ≥1 diaper rash in the 2 months preceding recruitment
Who cannot join
- Does not have a stable address at which to receive a package of Theraworx and is unable/unwilling to pick it up at Children's National Health System
- Infant is immunocompromised, has a congenital disorder, or on the day of recruitment, has a diaper rash, has a moderate to severe illness requiring hospitalization or transfer to the emergency room, or was circumcised <10 days prior.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chidlren's National Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: The Healthy Baby Bottoms Study: A Trial of Theraworx Foam Formulation for the Prevention and Treatment of Diaper Dermatitis
Diaper dermatitis is one of the most common dermatologic diseases affecting infants and children. The incidence is highest among those 9-12 months old and it has been reported to affect 7-50% of infants in the US. It is caused by skin exposure to a combination of several factors including: excessive moisture, topical irritants, reduced pH, friction, maceration and bacterial infection. When infants soil their diaper, diaper contents saturate the area raising the pH of the skin above the normal level of 5 or less, and leaving the area highly vulnerable to maceration from friction. Irritants in urine and feces are then able to penetrate the macerated skin, causing inflammation and greater skin friability. An elevation in the skin pH allows pathogenic bacteria to overgrow, and combined with the breakdown in the skin's outer epithelial barrier, can lead to bacterial infection. Theraworx Foam Formulation-Allantoin Liquid by Avadim Technologies, Inc. is a skin protectant with use for temporary protection of minor cuts, scrapes, burns and chapped or cracked skin. As such, Theraworx Foam used in the diaper area may be beneficial for protecting skin against diaper rash wounds, as well as for assisting with wound healing and reducing any associated pain. The purpose of this study is to determine caregivers' perceptions of the benefits of using Theraworx Foam on their infant's diaper area as part of their hygienic routine, including whether they feel the product is pleasant and easy to use, and whether they feel it helps prevent and reduce the severity of diaper dermatitis in their infants 1-14 months old.
- Conditions
- Diaper Dermatitis
- Being tested
- Diaper care with Theraworx
- Medical subject headings
- Diaper Rash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaper care with TheraworxDrug
Theraworx foam formulation to be used as a preventive and treatment agent for diaper rashes
| Study group | Role | What they receive |
|---|---|---|
| Diaper care with Theraworx | Experimental | Participants will be given a 4 week supply of Theraworx Spray Foam, an FDA-registered OTC drug (NDC 61594-000), to apply a thin layer to their infant's entire diaper area with every diaper change (2-4 foam pumps or 4-6 sprays depending on the infant's size) for 4 weeks. Receives: Drug: Diaper care with Theraworx |
| Routine diaper care | No intervention | Participants continue their typical diaper care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver's Self-report of Prevention of Diaper Dermatitis in Infant
Caregivers self-report on a weekly basis the total number of days during the past week that their infant had a diaper rash. Diaper rash was defined as the presence of one or more of the following in the diaper region: redness, skin breakdown, papules or pustules. The total number of days with diaper rash for the entire 4 week period was summed from the 4 weekly surveys (outcome measure range: 0-28 days with fewer days representing a better outcome).
Measured: 4 weeks
Secondary outcomes (1)
Caregiver's Self-report of Diaper Rash Severity
Caregivers used a modified Diaper Dermatitis Scale (Buckley, et al, Pediatric Dermatology 2016) to report infant diaper rash severity. The scale ranged from 0 (none) to 6 (most severe) with higher scores indicating a worse outcome. Items on the scale included assessments of rash size (0-2), redness (0-1), evidence of skin breakdown (0-1), evidence of papules (0-1) and evidence of pustules (0-1). Mean score was calculated using scores for every day over 28 days.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start12 Mar 2020
- Primary completion2 Jan 2021
- Study completion2 Jan 2021
Why it stopped: Principal Investigator left the Institution and decision was made by funders to terminate the trial.
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 Diaper DermatitisStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linda Fu
- Sponsor type
- University, hospital or other
- Collaborators
- Avadim Technologies, Inc.
- Responsible party
- Sponsor-investigator, Linda Fu, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101890
- Sponsor's protocol ID
- 12239
- Status last verified
- Nov 2021
- First submitted
- 16 Sep 2019
- Last updated
- 17 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Healthy Baby Bottoms Study: A Trial of Theraworx Foam Formulation for the Prevention and Treatment of Diaper Dermatitis
- ClinicalTrials.gov ID
- NCT04101890
- Acronym / sponsor ID
- 12239
- Conditions
- Diaper Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator left the Institution and decision was made by funders to terminate the trial.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Linda FuUniversity, hospital or other
- Collaborators
- Avadim Technologies, Inc.
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 2 Jan 2021 (actual)
- Study completion
- 2 Jan 2021 (actual)
- First posted
- 24 Sep 2019 (actual)
- Results
- Posted 17 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diaper dermatitis is one of the most common dermatologic diseases affecting infants and children. The incidence is highest among those 9-12 months old and it has been reported to affect 7-50% of infants in the US. It is caused by skin exposure to a combination of several factors including: excessive moisture, topical irritants, reduced pH, friction, maceration and bacterial infection. When infants soil their diaper, diaper contents saturate the area raising the pH of the skin above the normal level of 5 or less, and leaving the area highly vulnerable to maceration from friction. Irritants in urine and feces are then able to penetrate the macerated skin, causing inflammation and greater skin friability. An elevation in the skin pH allows pathogenic bacteria to overgrow, and combined with the breakdown in the skin's outer epithelial barrier, can lead to bacterial infection. Theraworx Foam Formulation-Allantoin Liquid by Avadim Technologies, Inc. is a skin protectant with use for temporary protection of minor cuts, scrapes, burns and chapped or cracked skin. As such, Theraworx Foam used in the diaper area may be beneficial for protecting skin against diaper rash wounds, as well as for assisting with wound healing and reducing any associated pain. The purpose of this study is to determine caregivers' perceptions of the benefits of using Theraworx Foam on their infant's diaper area as part of their hygienic routine, including whether they feel the product is pleasant and easy to use, and whether they feel it helps prevent and reduce the severity of diaper dermatitis in their infants 1-14 months old.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaper care with Theraworx | Experimental | Drug: Diaper care with TheraworxParticipants will be given a 4 week supply of Theraworx Spray Foam, an FDA-registered OTC drug (NDC 61594-000), to apply a thin layer to their infant's entire diaper area with every diaper change (2-4 foam pumps or 4-6 sprays depending on the infant's size) for 4 weeks. |
| Routine diaper care | No intervention | –Participants continue their typical diaper care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Read English at the 8th grade level
- Have reliable access to email for 7 weeks
- Complete the first online survey within 24 hours of the request
- Custodial guardian of an infant between the ages of 1-12 months old living with him/her, wearing diapers, and has had ≥1 diaper rash in the 2 months preceding recruitment
Key exclusion criteria (2 listed)
- Does not have a stable address at which to receive a package of Theraworx and is unable/unwilling to pick it up at Children's National Health System
- Infant is immunocompromised, has a congenital disorder, or on the day of recruitment, has a diaper rash, has a moderate to severe illness requiring hospitalization or transfer to the emergency room, or was circumcised <10 days prior.
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 |
|---|---|---|
| Diaper care with TheraworxTheraworx foam formulation to be used as a preventive and treatment agent for diaper rashes | Drug | Diaper care with Theraworx |
Primary outcome
Caregiver's Self-report of Prevention of Diaper Dermatitis in Infant
Time frame: 4 weeks
Caregivers self-report on a weekly basis the total number of days during the past week that their infant had a diaper rash. Diaper rash was defined as the presence of one or more of the following in the diaper region: redness, skin breakdown, papules or pustules. The total number of days with diaper rash for the entire 4 week period was summed from the 4 weekly surveys (outcome measure range: 0-28 days with fewer days representing a better outcome).
1 secondary outcome
Caregiver's Self-report of Diaper Rash Severity
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Diaper Dermatitis
Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
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Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
Not yet recruiting
Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months
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Probiotics for Diaper Dermatitis
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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 Phase 4 study testing Diaper care with Theraworx in people with Diaper Dermatitis, run by Linda Fu 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 4 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 17 Dec 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2021). 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?
Caregiver's Self-report of Prevention of Diaper Dermatitis in Infant (time frame: 4 weeks). 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 17 Dec 2021.