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Effect of sequential applications of topical tacrolimus and topical corticosteroids in the treatment of pediatric atopic dermatitis: an open-label pilot study.
J Am Acad Dermatol. 2009 Feb; 60(2):212-7.JA

Abstract

BACKGROUND

The efficacy of combination therapy with topical corticosteroids and tacrolimus in the treatment of atopic dermatitis remains to be established.

OBJECTIVE

Our aim was to determine whether a regimen of sequential application of topical corticosteroids and topical tacrolimus is effective in the treatment of pediatric atopic dermatitis. A second goal was to assess the impact of this treatment regimen on quality of life (QOL) and the response shift on QOL changes.

METHODS

The study regimen consisted of 3 phases. In the induction phase, patients were treated for a 2-week period with application of 0.03% tacrolimus ointment in the morning and application of a strong- or weak-potency corticosteroid ointment in the evening. In the transitional phase, they were treated for an additional 2 weeks with 0.03% tacrolimus ointment twice daily on weekdays and concurrent application of tacrolimus and a topical corticosteroid ointment on weekend days. In the maintenance phase, the corticosteroid ointment was discontinued and 0.03% tacrolimus ointment was applied twice daily for an additional 2 weeks. Daily application of tacrolimus ointment was then discontinued and replaced by an emollient with application of 0.03% tacrolimus ointment only when necessary for an additional 6 weeks. The Eczema Area and Severity Index score, Investigators' Global Assessment, severity of pruritus and sleep disturbance scores, and QOL evaluation were measured. After 12 weeks, the patients completed a retrospective version of the pretreatment QOL evaluation for analysis of response shift bias.

RESULTS

Eczema Area and Severity Index scores decreased by the sixth week, and continued improvement was observed during an additional 6-week period. Both the pruritus and sleep disturbance scores decreased throughout the study. Of patients, 90% showed marked clinical improvement at week 6 and 96% at week 12. On the Children's Dermatology Life Quality Index and the Infant's Dermatology QOL Index survey, mean QOL scores improved after completion of therapy at week 12. The mean difference between the pretest and the retrospective pretest scores indicated the presence of a response shift bias.

LIMITATIONS

This was an uncontrolled, open-label study. Conclusions are limited by the small sample size.

CONCLUSIONS

A fixed sequential regimen of application of tacrolimus ointment with tapering of topical corticosteroids may limit the long-term use and adverse effects of topical corticosteroids, while maintaining clinical control of pediatric atopic dermatitis and improving the QOL. The finding of a response shift bias suggests that parents/guardians underestimate the seriousness of skin disease and its impact on QOL.

Authors+Show Affiliations

Department of Dermatology, Faculty of Medicine, Kagawa University, Kagawa, Japan. kubotay@kms.ac.jpNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

19027990

Citation

Kubota, Yasuo, et al. "Effect of Sequential Applications of Topical Tacrolimus and Topical Corticosteroids in the Treatment of Pediatric Atopic Dermatitis: an Open-label Pilot Study." Journal of the American Academy of Dermatology, vol. 60, no. 2, 2009, pp. 212-7.
Kubota Y, Yoneda K, Nakai K, et al. Effect of sequential applications of topical tacrolimus and topical corticosteroids in the treatment of pediatric atopic dermatitis: an open-label pilot study. J Am Acad Dermatol. 2009;60(2):212-7.
Kubota, Y., Yoneda, K., Nakai, K., Katsuura, J., Moriue, T., Matsuoka, Y., Miyamoto, I., & Ohya, Y. (2009). Effect of sequential applications of topical tacrolimus and topical corticosteroids in the treatment of pediatric atopic dermatitis: an open-label pilot study. Journal of the American Academy of Dermatology, 60(2), 212-7. https://doi.org/10.1016/j.jaad.2008.09.034
Kubota Y, et al. Effect of Sequential Applications of Topical Tacrolimus and Topical Corticosteroids in the Treatment of Pediatric Atopic Dermatitis: an Open-label Pilot Study. J Am Acad Dermatol. 2009;60(2):212-7. PubMed PMID: 19027990.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of sequential applications of topical tacrolimus and topical corticosteroids in the treatment of pediatric atopic dermatitis: an open-label pilot study. AU - Kubota,Yasuo, AU - Yoneda,Kozo, AU - Nakai,Kozo, AU - Katsuura,Junko, AU - Moriue,Tetsuya, AU - Matsuoka,Yoshie, AU - Miyamoto,Izumi, AU - Ohya,Yukihiro, Y1 - 2008/11/22/ PY - 2007/10/12/received PY - 2008/09/23/revised PY - 2008/09/23/accepted PY - 2008/11/26/pubmed PY - 2009/2/28/medline PY - 2008/11/26/entrez SP - 212 EP - 7 JF - Journal of the American Academy of Dermatology JO - J. Am. Acad. Dermatol. VL - 60 IS - 2 N2 - BACKGROUND: The efficacy of combination therapy with topical corticosteroids and tacrolimus in the treatment of atopic dermatitis remains to be established. OBJECTIVE: Our aim was to determine whether a regimen of sequential application of topical corticosteroids and topical tacrolimus is effective in the treatment of pediatric atopic dermatitis. A second goal was to assess the impact of this treatment regimen on quality of life (QOL) and the response shift on QOL changes. METHODS: The study regimen consisted of 3 phases. In the induction phase, patients were treated for a 2-week period with application of 0.03% tacrolimus ointment in the morning and application of a strong- or weak-potency corticosteroid ointment in the evening. In the transitional phase, they were treated for an additional 2 weeks with 0.03% tacrolimus ointment twice daily on weekdays and concurrent application of tacrolimus and a topical corticosteroid ointment on weekend days. In the maintenance phase, the corticosteroid ointment was discontinued and 0.03% tacrolimus ointment was applied twice daily for an additional 2 weeks. Daily application of tacrolimus ointment was then discontinued and replaced by an emollient with application of 0.03% tacrolimus ointment only when necessary for an additional 6 weeks. The Eczema Area and Severity Index score, Investigators' Global Assessment, severity of pruritus and sleep disturbance scores, and QOL evaluation were measured. After 12 weeks, the patients completed a retrospective version of the pretreatment QOL evaluation for analysis of response shift bias. RESULTS: Eczema Area and Severity Index scores decreased by the sixth week, and continued improvement was observed during an additional 6-week period. Both the pruritus and sleep disturbance scores decreased throughout the study. Of patients, 90% showed marked clinical improvement at week 6 and 96% at week 12. On the Children's Dermatology Life Quality Index and the Infant's Dermatology QOL Index survey, mean QOL scores improved after completion of therapy at week 12. The mean difference between the pretest and the retrospective pretest scores indicated the presence of a response shift bias. LIMITATIONS: This was an uncontrolled, open-label study. Conclusions are limited by the small sample size. CONCLUSIONS: A fixed sequential regimen of application of tacrolimus ointment with tapering of topical corticosteroids may limit the long-term use and adverse effects of topical corticosteroids, while maintaining clinical control of pediatric atopic dermatitis and improving the QOL. The finding of a response shift bias suggests that parents/guardians underestimate the seriousness of skin disease and its impact on QOL. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/19027990/Effect_of_sequential_applications_of_topical_tacrolimus_and_topical_corticosteroids_in_the_treatment_of_pediatric_atopic_dermatitis:_an_open_label_pilot_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0190-9622(08)01215-2 DB - PRIME DP - Unbound Medicine ER -