Diaper RashNCT03640897
Evaluation of the Safety and Performance of LiNiDERM® in the Prevention of Infant Diaper Rash
A study testing Liniderm, Wipes and Water in people with Diaper Rash, run by Laboratoires Gilbert at 1 site in Poland.
Trial summary
Result of immaturity of the skin and factors promoting maceration and mechanical interactions, Irritant diaper dermatitis (IDD) can manifest as early as the third week of life. IDD is a form of contact dermatitis and is the most common inflammatory dermatitis of the diaper area infants. Read more about this study
- Who is it for?
- Ages 3 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Diaper Rash
- What is being tested?
- Liniderm, Wipes and Water
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 sitePoland
- Study dates
- 2 Aug 2018to 18 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 3 - 36 months, in good health, born at term or up to 1 month before term,
- A skin phototype I- III according to Fitzpatrick scale,
- Wearing diapers daily with at least 2 changes per day and a night port,
- For whom parents have given their written informed consent regarding its participation in this clinical investigation.
Who cannot join
- Wearing washable or pull-on diapers,
- Presenting a diaper rash (in progress),
- Presenting a cutaneous pathology known,
- Treated actually by phototherapy,
- Presenting a cow's milk protein allergy,
- Under medical treatment which may interfere with studied products and/ or skin in the 4-weeks prior to enrolment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Performance of LiNiDERM® in the Prevention of Infant Diaper Rash: a Randomized Clinical Trial
Result of immaturity of the skin and factors promoting maceration and mechanical interactions, Irritant diaper dermatitis (IDD) can manifest as early as the third week of life. IDD is a form of contact dermatitis and is the most common inflammatory dermatitis of the diaper area infants. This dermatitis is very common amongst first year of life.
The IDD is characterized by erythema on the convex surfaces with the skin folds spared (W-shaped erythema) and it can cause considerable pain and stress for infants and can be troublesome for their caregivers.
Read more
The development of IDD is multifactorial. The critical step in the development of IDD is the occlusion of the skin under the diaper. The skin in the diaper area is predisposed to irritation by the presence of urine, stool, friction on the skin and presence of a high skin pH (potential Hydrogen).
At the cellular level, there is a gradual disorganization of the lipid layers and later an attack of keratinocytes. Clinically, maceration is followed by an inflammatory reaction.
Hence, infrequent diaper changes create overhydration and maceration of the stratum corneum, which makes the skin more sensitive to friction; this may interfere with the protective barrier function, allowing for the exposure of the lower layers to irritants (mechanical, chemical and infectious).
The removal of maceration and the reduction of friction are the key to prevention. But it is recommended to respect preventive measures, in order to preserve the normal skin condition over the long term. Special care procedures are required to ensure healthy development and to protect the skin from irritation and inflammation, as well as a sense of well-being. Although use of appropriately formulated cleansers and emollients can help maintain the epidermal skin barrier in the diaper region, good hygiene and adequate protection are necessary to prevent skin barrier breakdown, rash and infection. The prevention of IDD includes frequent diaper changing, parent education and cleaning.
LiNiRASH is a monocentric, prospective, randomized, comparator controlled study conducted under paediatric control. 132 infants will be followed in this study for 4 weeks during which their parents will use a specific cleaning method: water and cotton pads or wipes or liniment. The objective of this study is to compare the performance and safety of this 3 cleaning methods on the prevention of infant diaper rash.
- Conditions
- Diaper Rash
- Being tested
- Liniderm, Wipes, Water
- Keywords
- Infant diaper rash, Baby wipes, Oleocalcareous liniment
- Medical subject headings
- Diaper Rash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinidermDevice
Cleaning of the diaper area with Liniderm at each diaper change during 28 days
WipesOther
Cleaning of the diaper area with wipes at each diaper change during 28 days
WaterOther
Cleaning of the diaper area with water and cotton pads at each diaper change during 28 days
| Study group | Role | What they receive |
|---|---|---|
| Liniderm | Experimental | Oleocalcareous liniment Liniderm:
The product will be applied on the diaper area by parents/ caregivers at each diaper change. Receives: Device: Liniderm |
| Wipes | Active comparator | Free-fragrance baby wipes The product will be used on the diaper area by parents/ caregivers at each diaper change. Receives: Other: Wipes |
| Water | Active comparator | Water and cotton pads The product will be used on the diaper area by parents/ caregivers at each diaper change. Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infants who had at least one episode of diaper rash
Every day, in a daily log, parents/ caregivers will report the presence or not of a diaper rash.
At the end of the follow-up, the investigator must identify infant who have had at least one episode of diaper rash.
Measured: 28 days
Secondary outcomes (7)
Severity of diaper rash episodes: rating
Every day, parents/ caregivers will report the rating of erythema if applicable using an illustrated scale ( 4 points scale).
The rating scale is: 0 (Normal skin), 1 (Mild erythema/ pink skin), 2 (Severe erythema/ red skin) and 3 (Erythema with skin erosion).
Measured: Continuously for 28 days
Severity of diaper rash episodes: extent
Every day, parents/ caregivers will report the extent of erythema if applicable using an illustrated scale ( 4 points scale).
The extent scale is: 0 (Healthy skin), 1 (On the folds/ small spread), 2 (On the convexity/ moderate spread) and 3 (Wide spread).
Measured: Continuously for 28 days
Safety of the cleaning method
Every day, parents will report intolerance/ discomfort felt. Also, at each visit, the investigator will carry out a clinical examination of the diaper area; the investigator will assess the tolerance using a 4-points Likert scale.
The 4-points Likert scale is: Bad (0), Moderate (1), Good (2) or Very good (3)
Measured: Continuously for 28 days
Skin evaluation on the genital area
Assessment of the skin integrity using a numeric scale (6 points) by the paediatrician at each visit.
The numeric scale is: 0 (No rash), 1 (Mild irritation or rash), 2 (Moderate irritation or rash), 3 (Considerable irritation or rash), 4 (Extreme irritation or rash) and 5 (Extreme erythema involving entire area, oozing papules, pustules erosion).
Skin colour measurements using a Chroma Meter.
Measured: 0, 14 and 28 days
Paediatrician satisfaction
The paediatrician's satisfaction (regarding performance) will be assessed for each infant using a 4-point Likert scale.
The 4-point Likert scale is: Bad (0), Moderate (1), Good (2) or Very good (3)
Measured: 14 and 28 days
Well-being
The well-being of infant will be assessed by parents at each visit. Questions will be about crying, agitation, tension and scratching (Yes/ No).
Measured: 0, 14 and 28 days
Parents satisfaction
The parents' satisfaction (regarding performance and safety) will be assessed using a 4-point Likert scale.
The 4-point Likert scale is: Bad (0), Moderate (1), Good (2) or Very good (3)
Measured: 14 and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start2 Aug 2018
- Primary completion18 Mar 2019
- Study completion18 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaper RashStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A monocentric, prospective, randomized, comparator controlled, parallel groups study conducted under paediatric control.
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Gilbert
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640897
- Sponsor's protocol ID
- LiNiRash
- Status last verified
- Apr 2019
- First submitted
- 16 Jul 2018
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Performance of LiNiDERM® in the Prevention of Infant Diaper Rash: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03640897
- Acronym / sponsor ID
- LiNiRash
- Conditions
- Diaper Rash
- Keywords
- Infant diaper rash, Baby wipes, Oleocalcareous liniment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Laboratoires GilbertIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Result of immaturity of the skin and factors promoting maceration and mechanical interactions, Irritant diaper dermatitis (IDD) can manifest as early as the third week of life. IDD is a form of contact dermatitis and is the most common inflammatory dermatitis of the diaper area infants. This dermatitis is very common amongst first year of life.
The IDD is characterized by erythema on the convex surfaces with the skin folds spared (W-shaped erythema) and it can cause considerable pain and stress for infants and can be troublesome for their caregivers.
The development of IDD is multifactorial. The critical step in the development of IDD is the occlusion of the skin under the diaper. The skin in the diaper area is predisposed to irritation by the presence of urine, stool, friction on the skin and presence of a high skin pH (potential Hydrogen).
At the cellular level, there is a gradual disorganization of the lipid layers and later an attack of keratinocytes. Clinically, maceration is followed by an inflammatory reaction.
Hence, infrequent diaper changes create overhydration and maceration of the stratum corneum, which makes the skin more sensitive to friction; this may interfere with the protective barrier function, allowing for the exposure of the lower layers to irritants (mechanical, chemical and infectious).
The removal of maceration and the reduction of friction are the key to prevention. But it is recommended to respect preventive measures, in order to preserve the normal skin condition over the long term. Special care procedures are required to ensure healthy development and to protect the skin from irritation and inflammation, as well as a sense of well-being. Although use of appropriately formulated cleansers and emollients can help maintain the epidermal skin barrier in the diaper region, good hygiene and adequate protection are necessary to prevent skin barrier breakdown, rash and infection. The prevention of IDD includes frequent diaper changing, parent education and cleaning.
LiNiRASH is a monocentric, prospective, randomized, comparator controlled study conducted under paediatric control. 132 infants will be followed in this study for 4 weeks during which their parents will use a specific cleaning method: water and cotton pads or wipes or liniment. The objective of this study is to compare the performance and safety of this 3 cleaning methods on the prevention of infant diaper rash.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A monocentric, prospective, randomized, comparator controlled, parallel groups study conducted under paediatric control.
| Arm | Type | Receives |
|---|---|---|
| Liniderm | Experimental | Device: LinidermOleocalcareous liniment Liniderm: The product will be applied on the diaper area by parents/ caregivers at each diaper change. |
| Wipes | Active comparator | Other: WipesFree-fragrance baby wipes The product will be used on the diaper area by parents/ caregivers at each diaper change. |
| Water | Active comparator | Other: WaterWater and cotton pads The product will be used on the diaper area by parents/ caregivers at each diaper change. |
Who may qualify
- Ages
- 3 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 3 - 36 months, in good health, born at term or up to 1 month before term,
- A skin phototype I- III according to Fitzpatrick scale,
- Wearing diapers daily with at least 2 changes per day and a night port,
- For whom parents have given their written informed consent regarding its participation in this clinical investigation.
Key exclusion criteria (6 listed)
- Wearing washable or pull-on diapers,
- Presenting a diaper rash (in progress),
- Presenting a cutaneous pathology known,
- Treated actually by phototherapy,
- Presenting a cow's milk protein allergy,
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 |
|---|---|---|
| LinidermCleaning of the diaper area with Liniderm at each diaper change during 28 days | Device | Liniderm |
| WipesCleaning of the diaper area with wipes at each diaper change during 28 days | Other | Wipes |
| WaterCleaning of the diaper area with water and cotton pads at each diaper change during 28 days | Other | Water |
Primary outcome
Number of infants who had at least one episode of diaper rash
Time frame: 28 days
Every day, in a daily log, parents/ caregivers will report the presence or not of a diaper rash. At the end of the follow-up, the investigator must identify infant who have had at least one episode of diaper rash.
7 secondary outcomes
Severity of diaper rash episodes: rating
Time frame: Continuously for 28 days
Severity of diaper rash episodes: extent
Time frame: Continuously for 28 days
Safety of the cleaning method
Time frame: Continuously for 28 days
Skin evaluation on the genital area
Time frame: 0, 14 and 28 days
Paediatrician satisfaction
Time frame: 14 and 28 days
Well-being
Time frame: 0, 14 and 28 days
Parents satisfaction
Time frame: 14 and 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No
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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
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Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months
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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 Liniderm, Wipes and Water in people with Diaper Rash, run by Laboratoires Gilbert at 1 site in Poland.
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 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 4 Apr 2019. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of infants who had at least one episode of diaper rash (time frame: 28 days). 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 4 Apr 2019.