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. 2021 Feb 5;2021(2):CD013534. doi: 10.1002/14651858.CD013534.pub2

NCT03640897.

Methods Monocentric, prospective, randomised, comparator‐controlled, parallel‐group study 
Participants 133 participants
Interventions Experimental: Liniderm
Oleocalcareous liniment Liniderm:
The product will be applied on the diaper area by parents/caregivers at each diaper change
Active comparator: wipes
Free‐fragrance baby wipes. The product will be used on the diaper area by parents/caregivers at each diaper change
Active comparator: water
Water and cotton pads. The product will be used on the diaper area by parents/caregivers at each diaper change
Outcomes Primary outcomes: 
Number of infants who had at least 1 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 follow‐up, the investigator must identify infants who have had at least 1 episode of diaper rash
Secondary outcomes: 
  1. Severity of diaper rash episodes: rating [Time Frame: Continuously for 28 days]

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

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

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

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

  6. Well‐being [Time Frame: 0, 14, and 28 days]

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

Notes  

Supported by Johnson & Johnson Consumer Inc.