A randomized, controlled, cross-over study of the safety and efficacy of superabsorbent diaper for babies with mild-to-moderate diaper rash

  • Inne Arline Diana Indonesian Pediatric Dermatology Study Group, Indonesian Society of Dermatology and Venereology, Jakarta, Indonesia; Department of Dermatology and Venereology, Faculty of Medicine, Universitas Padjadjaran, Hasan Sadikin Hospital, Bandung, Indonesia
  • Srie Prihianti Gondokaryono Indonesian Pediatric Dermatology Study Group, Indonesian Society of Dermatology and Venereology, Jakarta, Indonesia; Department of Dermatology and Venereology, Faculty of Medicine, Universitas Padjadjaran, Hasan Sadikin Hospital, Bandung, Indonesia
  • Titi Lestari Sugito Indonesian Pediatric Dermatology Study Group, Indonesian Society of Dermatology and Venereology, Jakarta, Indonesia https://orcid.org/0000-0001-6291-3858
  • Maya Devita Lokanata Indonesian Pediatric Dermatology Study Group, Indonesian Society of Dermatology and Venereology, Jakarta, Indonesia
  • Triana Agustin Indonesian Pediatric Dermatology Study Group, Indonesian Society of Dermatology and Venereology, Jakarta, Indonesia; Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia
  • Githa Rahmayunita Indonesian Pediatric Dermatology Study Group, Indonesian Society of Dermatology and Venereology, Jakarta, Indonesia; Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia https://orcid.org/0000-0002-3480-0511
  • Indah Maharani Indonesian Pediatric Dermatology Study Group, Indonesian Society of Dermatology and Venereology, Jakarta, Indonesia
  • Nanny Shoraya Indonesian Pediatric Dermatology Study Group, Indonesian Society of Dermatology and Venereology, Jakarta, Indonesia; Dermatovenereology Medical Unit, Harapan Kita Women and Children Hospital, Jakarta, Indonesia
  • Haruko Toyoshima KAO Corporation, Tochigi, Japan
  • Danang Agung Yunaidi PT Equilab International, Jakarta, Indonesia
Keywords: efficacy, safety, super-absorbent diaper
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Abstract

BACKGROUND Super-absorbent diaper is a disposable diaper with new technology which has a soft-airy structure, breathable sheet, and rich absorbent core. This study aimed to compare the safety and efficacy of super-absorbent diaper with standard absorbent diaper.

METHODS A single-blinded, randomized, controlled, cross-over study was performed in 324 months babies. A safety study was performed in 113 babies without diaper rash (group A: super-absorbent to standard and B: standard to super-absorbent) and efficacy study in 59 babies with mild-to-moderate diaper rash (group C: super-absorbent to standard and D: standard to super-absorbent). Each group used super-absorbent or standard diaper for 2 weeks. Skin assessment scores (SAS) were recorded at baseline, week-2, and week-4. Non-parametric tests were used to analyze the data.

RESULTS In the safety study, there was no significant increase of SAS in group A at week-2 and -4, but in group B there was a significant increase of SAS (1.9 to 4.1, p = 0.001) at week-2 with a significant reduction at week-4 (4.1 to 2.2, p<0.001). In the efficacy study, there was a reduction of SAS at week-2 in group C (p = 0.07) and D (p = 0.05). However, SAS increased in group C (6.4 to 8.3, p = 0.2) and decreased in group D (8.6 to 6.1, p = 0.13) at week-4. Super-absorbent diaper showed a significant reduction of SAS in the pubic areas (1.43 to 0.73, p<0.011).

CONCLUSIONS The new super-absorbent diaper is safe to use and may have efficacy in the improvement of skin conditions and diaper rash, especially in the pubic areas.

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Published
2020-10-05
How to Cite
1.
Diana IA, Gondokaryono SP, Sugito TL, Lokanata MD, Agustin T, Rahmayunita G, Maharani I, Shoraya N, Toyoshima H, Yunaidi DA. A randomized, controlled, cross-over study of the safety and efficacy of superabsorbent diaper for babies with mild-to-moderate diaper rash. Med J Indones [Internet]. 2020Oct.5 [cited 2020Dec.3];29(3):283-9. Available from: http://mji.ui.ac.id/journal/index.php/mji/article/view/3630
Section
Clinical Research