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Evaluation of the Safety and Performance of LiNiDERM® in the Prevention of Infant Diaper Rash

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03640897
Recruitment Status : Completed
First Posted : August 21, 2018
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Slb Pharma
Information provided by (Responsible Party):
Laboratoires Gilbert

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Diaper Rash Device: Liniderm Other: Wipes Other: Water Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A monocentric, prospective, randomized, comparator controlled, parallel groups study conducted under paediatric control.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Safety and Performance of LiNiDERM® in the Prevention of Infant Diaper Rash: a Randomized Clinical Trial
Actual Study Start Date : August 2, 2018
Actual Primary Completion Date : March 18, 2019
Actual Study Completion Date : March 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Experimental: Liniderm

Oleocalcareous liniment Liniderm:

The product will be applied on the diaper area by parents/ caregivers at each diaper change.

Device: Liniderm
Cleaning of the diaper area with Liniderm at each diaper change during 28 days

Active Comparator: Wipes
Free-fragrance baby wipes The product will be used on the diaper area by parents/ caregivers at each diaper change.
Other: Wipes
Cleaning of the diaper area with wipes at each diaper change during 28 days

Active Comparator: Water
Water and cotton pads The product will be used on the diaper area by parents/ caregivers at each diaper change.
Other: Water
Cleaning of the diaper area with water and cotton pads at each diaper change during 28 days




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Severity of diaper rash episodes: rating [ Time Frame: Continuously for 28 days ]

    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).


  2. Severity of diaper rash episodes: extent [ Time Frame: Continuously for 28 days ]

    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).


  3. Safety of the cleaning method [ Time Frame: Continuously for 28 days ]

    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)


  4. Skin evaluation on the genital area [ Time Frame: 0, 14 and 28 days ]

    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.


  5. Paediatrician satisfaction [ Time Frame: 14 and 28 days ]

    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)


  6. Well-being [ Time Frame: 0, 14 and 28 days ]
    The well-being of infant will be assessed by parents at each visit. Questions will be about crying, agitation, tension and scratching (Yes/ No).

  7. Parents satisfaction [ Time Frame: 14 and 28 days ]

    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)




Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640897


Locations
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Poland
Dermscan
Gdańsk, Poland
Sponsors and Collaborators
Laboratoires Gilbert
Slb Pharma
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Responsible Party: Laboratoires Gilbert
ClinicalTrials.gov Identifier: NCT03640897    
Other Study ID Numbers: LiNiRash
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laboratoires Gilbert:
Infant diaper rash
Baby wipes
Oleocalcareous liniment
Additional relevant MeSH terms:
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Diaper Rash
Skin Diseases
Dermatitis, Irritant
Dermatitis, Contact
Dermatitis
Skin Diseases, Eczematous