Evaluation of the Safety and Performance of LiNiDERM® in the Prevention of Infant Diaper Rash
1 other identifier
interventional
133
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2018
CompletedStudy Start
First participant enrolled
August 2, 2018
CompletedFirst Posted
Study publicly available on registry
August 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2019
CompletedApril 4, 2019
April 1, 2019
8 months
July 16, 2018
April 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
28 days
Secondary Outcomes (7)
Severity of diaper rash episodes: rating
Continuously for 28 days
Severity of diaper rash episodes: extent
Continuously for 28 days
Safety of the cleaning method
Continuously for 28 days
Skin evaluation on the genital area
0, 14 and 28 days
Paediatrician satisfaction
14 and 28 days
- +2 more secondary outcomes
Study Arms (3)
Liniderm
EXPERIMENTALOleocalcareous liniment Liniderm: The product will be applied on the diaper area by parents/ caregivers at each diaper change.
Wipes
ACTIVE COMPARATORFree-fragrance baby wipes The product will be used on the diaper area by parents/ caregivers at each diaper change.
Water
ACTIVE COMPARATORWater and cotton pads The product will be used on the diaper area by parents/ caregivers at each diaper change.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laboratoires Gilbertlead
- Slb Pharmacollaborator
Study Sites (1)
Dermscan
Gdansk, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2018
First Posted
August 21, 2018
Study Start
August 2, 2018
Primary Completion
March 18, 2019
Study Completion
March 18, 2019
Last Updated
April 4, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share