Evaluation of the Safety and Performance of LiNiDERM® in the Prevention of Infant Diaper Rash
Condition: Diaper Rash
MeSH terms: Diaper Rash
Study type: Interventional

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.
    


Intervention name(s): Liniderm; Wipes; Water
Intervention type(s): Device; Other; Other
Intervention description(s): Cleaning of the diaper area with Liniderm at each diaper change during 28 days; Cleaning of the diaper area with wipes at each diaper change during 28 days; Cleaning of the diaper area with water and cotton pads at each diaper change during 28 days
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
Keywords: Infant diaper rash; Baby wipes; Oleocalcareous liniment