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
DOI: https://doi.org/10.13181/mji.oa.203630
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 2024Jul.3];29(3):283-9. Available from: http://mji.ui.ac.id/journal/index.php/mji/article/view/3630
Issue
Vol. 29 No. 3 (2020): September
Section
Clinical Research

Copyright (c) 2020 Titi Lestari Sugito, Maya Devita Lokanata, Triana Agustin, Githa Rahmayunita, Indah Maharani, Nanny Shoraya, Danang Agung Yunaidi, Haruko Toyoshima, Inne Arline Diana, Srie Prihianti Gondokaryono

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