Clinical trial NCT03640897: Evaluation of the Safety and Performance of LiNiDERM® in the Prevention of Infant Diaper Rash
Official title: Evaluation of the Safety and Performance of LiNiDERM® in the Prevention of Infant Diaper Rash: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diaper Rash
Keywords: Infant diaper rash
Baby wipes
Oleocalcareous liniment
Lead sponsor: Laboratoires Gilbert
Sponsor class: INDUSTRY
Collaborators: name: Slb Pharma
First posted: 2018-08-21
Enrollment: 133
Sex: ALL
Minimum age (years): 3
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A monocentric, prospective, randomized, comparator controlled, parallel groups study conducted under paediatric control.
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Number of infants who had at least one episode of diaper rash
timeFrame: 28 days
Secondary outcomes:
measure: Severity of diaper rash episodes: rating
timeFrame: Continuously for 28 days
measure: Severity of diaper rash episodes: extent
timeFrame: Continuously for 28 days
measure: Safety of the cleaning method
timeFrame: Continuously for 28 days
measure: Skin evaluation on the genital area
timeFrame: 0, 14 and 28 days
measure: Paediatrician satisfaction
timeFrame: 14 and 28 days
measure: Well-being
timeFrame: 0, 14 and 28 days
measure: Parents satisfaction
timeFrame: 14 and 28 days
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Dermscan
Study officials:
References: