NCT03640897

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

Evaluation of the Safety and Performance of LiNiDERM® in the Prevention of Infant Diaper Rash: a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Laboratoires Gilbert · Industry
• Sex: All
• Age: 3 Months – 36 Months
• Healthy volunteers: Accepted

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.

Conditions

• Diaper Rash

Interventions

Type	Name	Description
DEVICE	Liniderm	Cleaning of the diaper area with Liniderm at each diaper change during 28 days
OTHER	Wipes	Cleaning of the diaper area with wipes at each diaper change during 28 days
OTHER	Water	Cleaning of the diaper area with water and cotton pads at each diaper change during 28 days

Timeline

• Start date: 2018-08-02
• Primary completion: 2019-03-18
• Completion: 2019-03-18
• First posted: 2018-08-21
• Last updated: 2019-04-04

Locations

1 site across 1 country: Poland