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The treatment of facial atopic dermatitis in children who are intolerant of, or dependent on, topical corticosteroids: a randomized, controlled clinical trial.
Br J Dermatol. 2009 Feb; 160(2):415-22.BJ

Abstract

BACKGROUND

Atopic dermatitis (AD) is most prevalent in areas of reduced skin barrier reserve, like face and neck, especially in children. Treatment with topical corticosteroids (TCS) is limited due to heightened risk of treatment-associated side-effects, thus necessitating alternative AD therapies.

OBJECTIVES

The primary study objective was to determine the efficacy of pimecrolimus cream 1% in children with mild-moderate facial AD dependent on/intolerant of TCS. Secondary objectives included effects on overall Eczema Area and Severity Index (EASI), head/neck EASI, pruritus severity and time to clearance of facial AD.

METHODS

A multicentre, double-blind (DB) study of < or = 6 weeks, followed by a 6-week, open-label (OL) phase was conducted. Two hundred patients (aged 2-11 years) were randomized 1:1 to pimecrolimus cream 1% (n = 99) or vehicle (n = 101) twice daily until clearance of facial AD or for a maximum of 6 weeks (DB phase). Sixteen patients receiving vehicle were allowed to switch to the OL phase at day 22.

RESULTS

Significantly more pimecrolimus-treated vs. vehicle-treated patients were cleared/almost cleared of facial AD (Investigators' Global Assessment 0/1): 74.5% vs. 51.0%, P < 0.001 (day 43) [57.1% vs. 36.0%, P = 0.004 (day 22)]. Median time to clearance was 22.0 vs. 43.0 days (pimecrolimus vs. vehicle, respectively). Statistically significant differences for pimecrolimus vs. vehicle were also seen on head/neck EASI, overall EASI, and head/neck pruritus scores. Adverse events were mainly mild-moderate, occurring with similar frequency in both treatment groups.

CONCLUSIONS

In children with facial dermatitis intolerant of/dependent on TCS, pimecrolimus cream 1% effectively controls eczema and pruritus and is well tolerated.

Authors+Show Affiliations

Department of Paediatric Dermatology, Catholic Children's Hospital, Wilhelmstift, Liliencronstr. 130, 22149 Hamburg, Germany. p.hoeger@kkh-wilhelmstift.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19067708

Citation

Hoeger, P H., et al. "The Treatment of Facial Atopic Dermatitis in Children Who Are Intolerant Of, or Dependent On, Topical Corticosteroids: a Randomized, Controlled Clinical Trial." The British Journal of Dermatology, vol. 160, no. 2, 2009, pp. 415-22.
Hoeger PH, Lee KH, Jautova J, et al. The treatment of facial atopic dermatitis in children who are intolerant of, or dependent on, topical corticosteroids: a randomized, controlled clinical trial. Br J Dermatol. 2009;160(2):415-22.
Hoeger, P. H., Lee, K. H., Jautova, J., Wohlrab, J., Guettner, A., Mizutani, G., & Hultsch, T. (2009). The treatment of facial atopic dermatitis in children who are intolerant of, or dependent on, topical corticosteroids: a randomized, controlled clinical trial. The British Journal of Dermatology, 160(2), 415-22. https://doi.org/10.1111/j.1365-2133.2008.08928.x
Hoeger PH, et al. The Treatment of Facial Atopic Dermatitis in Children Who Are Intolerant Of, or Dependent On, Topical Corticosteroids: a Randomized, Controlled Clinical Trial. Br J Dermatol. 2009;160(2):415-22. PubMed PMID: 19067708.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The treatment of facial atopic dermatitis in children who are intolerant of, or dependent on, topical corticosteroids: a randomized, controlled clinical trial. AU - Hoeger,P H, AU - Lee,K-H, AU - Jautova,J, AU - Wohlrab,J, AU - Guettner,A, AU - Mizutani,G, AU - Hultsch,T, Y1 - 2008/11/25/ PY - 2008/12/11/pubmed PY - 2009/4/14/medline PY - 2008/12/11/entrez SP - 415 EP - 22 JF - The British journal of dermatology JO - Br J Dermatol VL - 160 IS - 2 N2 - BACKGROUND: Atopic dermatitis (AD) is most prevalent in areas of reduced skin barrier reserve, like face and neck, especially in children. Treatment with topical corticosteroids (TCS) is limited due to heightened risk of treatment-associated side-effects, thus necessitating alternative AD therapies. OBJECTIVES: The primary study objective was to determine the efficacy of pimecrolimus cream 1% in children with mild-moderate facial AD dependent on/intolerant of TCS. Secondary objectives included effects on overall Eczema Area and Severity Index (EASI), head/neck EASI, pruritus severity and time to clearance of facial AD. METHODS: A multicentre, double-blind (DB) study of < or = 6 weeks, followed by a 6-week, open-label (OL) phase was conducted. Two hundred patients (aged 2-11 years) were randomized 1:1 to pimecrolimus cream 1% (n = 99) or vehicle (n = 101) twice daily until clearance of facial AD or for a maximum of 6 weeks (DB phase). Sixteen patients receiving vehicle were allowed to switch to the OL phase at day 22. RESULTS: Significantly more pimecrolimus-treated vs. vehicle-treated patients were cleared/almost cleared of facial AD (Investigators' Global Assessment 0/1): 74.5% vs. 51.0%, P < 0.001 (day 43) [57.1% vs. 36.0%, P = 0.004 (day 22)]. Median time to clearance was 22.0 vs. 43.0 days (pimecrolimus vs. vehicle, respectively). Statistically significant differences for pimecrolimus vs. vehicle were also seen on head/neck EASI, overall EASI, and head/neck pruritus scores. Adverse events were mainly mild-moderate, occurring with similar frequency in both treatment groups. CONCLUSIONS: In children with facial dermatitis intolerant of/dependent on TCS, pimecrolimus cream 1% effectively controls eczema and pruritus and is well tolerated. SN - 1365-2133 UR - https://www.unboundmedicine.com/medline/citation/19067708/The_treatment_of_facial_atopic_dermatitis_in_children_who_are_intolerant_of_or_dependent_on_topical_corticosteroids:_a_randomized_controlled_clinical_trial_ L2 - https://doi.org/10.1111/j.1365-2133.2008.08928.x DB - PRIME DP - Unbound Medicine ER -