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SAFETY AND EFFICACY STUDIES OF ASEAN DIAPER COMPARED TO

STANDARD DIAPER FOR MILD TO MODERATE DIAPER RASH IN


CHILDREN
InneArline Diana, Srie Prihianti Gondokaryono, Titi Lestari Sugito, Maya DevitaLokanata,
Triana Agustin, GithaRachmayunita, Indah Maharani, Nanny Soraya,
DanangAgungYunaidi*, Haruko Toyoshima**.
Indonesian Study Group of Pediatric Dermatology
Indonesian Society of Dermatology and Venereology, Jakarta, Indonesia
*PT Equilab International, Jakarta, Indonesia
**Kao Corporation, Tochigi, Japan
email: prihianti@gmail.com
Background:Diaper rash is one of the most common dermatologic condition in infants and
children. With the advent of superabsorbent disposable diapers, severe form of diaper rash
have diminished in incidence.1 A new improvement in technology of disposable diaper has
recently being developed and aim of these studies are to evaluate its safety and efficacy in
comparison with standard diapers.2
Methods: single blinded, randomized, controlled, crossover study. Subjects: babies age 3-24
months. Safety study: 113 healthy subjects, divided into 2 groups (A and B). Efficacy study:
59 subjects with mild to moderate diaper rash, divided into 2 groups (C and D). Each group
was given either Asean diaper or standard diaper for 2 weeks, and switched the diaper over
to use for another 2 weeks. Skin assessment score were made in 6 areas at baseline, week 2
and 4.
Results:
Safety study: Group A (Asean Standard) showed a non significant change from total score
from baseline to week 2 (p = 0.09), and from week 2 to weak 4 (p = 0.35).
Group B (Standard Asean) showed a significant increase of total score from baseline: 1.9
to week 2: 4.1 (p <0.001). However, from week 2 4 after using Asean diaper showed a
significant decrease of total score: 4.1 to 2.2 (p <0.001).
Efficacy study: Group C (Asean Standard) and Group D (Standard Asean) both showed
at tendency to decrease total score from baseline to week 2 (p = 0.07 and p = 0.05).
However, from week 2 to week 4, Group C showed a tendency of increasing total score: 6.4
to 8.3 (p = 0.2), while Group D showed a continuous decreasing of total score: 8.6 to 6.1 (p =
0.13). Asean diaper showed significant decrease of score at waist back and pubic areas (p
<0.05).
Conclusion:
Safety study: new Asean diaper is safe to use, and safer than standard. In addition, the
Asean diaper can contribute to the improvement of skin condition.
Efficacy study: Both diaper showed a tendency of improving of diaper rash. Asean diaper can
further improve diaper rash, especially at waist back, and pubic areas.
References:
1.Chang MW. Neonatal, pediatric, and adolescent dermatology. In Goldsmith LA, et al. eds.
Fitzpatricks Dermatology in General Medicine. 8thed, McGraw Hill, New York, 2012: 1197-8.
2. KAO, Japan. Global Merries actual skin condition research from 2006.
Keywords: Asean diaper, diaper rash