Trial data

Effect of Bepanthen® on protection from the causes of nappy rash in premature and full-term babies.

Bepanthen®'s effect on the protection from the causes of nappy rash on full-term and premature newborns has been demonstrated in a study.

Protocol:

The study of the protective effects of Bepanthen® took place in Lyon, France using 54 newborn babies of a gestational age between 30 and 38 amenorrheic weeks and free of nappy rash. Those who received Bepanthen® and those who did not were coupled according to their gestational and post-natal ages.

Daily care of the newborn's nappy area consisted of cleansing with the same mild soap then rinsing with water followed by pat drying. According to the randomisation, this care was followed by either an application of a thin layer of Bepanthen® or nothing. The presence of nappy rash at each changing was noted by the hospital personnel and evaluated according to topographical criteria and clinical criteria by intensity. The grading, done in double-blind by a non-informed doctor on standardised photos taken at the beginning and end of the study, confirmed the observations noted by the hospital personnel. The average length of the study was two weeks.

Results:

The population of 54 newborns included fifteen sets of twins. For twelve of these sets, one of the two newborn babies had Bepanthen® applied, the other did not. On this sub-population of twelve sets of twins, there was a significant difference between the newborns who received Bepanthen® and those who did not (respectively, 17% of cases of erythema compared to 58%; p = 0.025 Wilcoxon signed ranks test).

Bepanthen® tended to protect against the causes of nappy rash in premature or full-term babies compared with no ointment, although the overall difference failed to meet statistical significance (57% of cases of erythema appearance in the control group compared to 31% in the group who received Bepanthen®; p = 0.06 2 test).

Graph depicting the frequency of diaper rash appearance (%) for treated and non treated subjects

Conclusion:

Under the conditions of this study, Bepanthen® tended to protect against the causes of nappy rash when applied to the buttocks of newborn babies. Full details of the study are noted in Realites Pediatriques, 2001; 63: 33-38.

Clinical review of nappy rash

A recent review by Atherton (2004) looked at 'nappy rash and concluded'

'Positive action should be taken to prevent nappy rash. This should comprise gentle cleansing, careful nappy selection, changing the nappy as soon as possible after defecation, and application of a barrier preparation at every change'
Curr Med Res Opin 2004; 20(5): 645-649

The barrier preparation should mimic the skin's natural function by forming a long-lasting barrier to increase protection against irritants and micro-organisms, and to maintain optimum moisture levels with the stratum corneum. Ideally, the promotion and use of such products should be supported by evaluation in appropriately controlled clinical trials.'

Did you know?

Bepanthen® is so gentle it can be used at every nappy change, it can even be used on the highly sensitive skin of premature babies, as it contains no fragrance, preservatives, colours or antiseptics.

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