Tacrolimus ointment 0.03% is safe and effective for the treatment of mild to moderate atopic dermatitis in pediatric patients

Results from a randomized, double-blind, vehicle-controlled study

Lawrence A Schachner, Cindy Lamerson, Mary P. Sheehan, Mark Boguniewicz, Joy Mosser, Sharon Raimer, Toni Shull, Eileen Jaracz

Research output: Contribution to journalArticle

60 Citations (Scopus)

Abstract

Objective. This study was designed to compare the safety and efficacy of tacrolimus ointment 0.03% with vehicle ointment for the treatment of mild to moderate atopic dermatitis (AD) in pediatric patients. Methods. A total of 317 patients (2-15 years of age) with mild to moderate AD were randomized to receive tacrolimus ointment or vehicle ointment twice daily in a 6-week, multicenter, double-blind study. Efficacy evaluations, including the Investigators' Global Atopic Dermatitis Assessment, eczema area and severity index, percentage of total body surface area affected, and patient assessment of itch occurred at baseline, day 4, and weeks 2, 4, and 6. Cutaneous adverse events were recorded to evaluate safety. Results. At the end of study, 50.6% (80 of 158) of the patients were treated successfully with tacrolimus ointment based on Investigators' Global Atopic Dermatitis Assessment scores, a significant improvement compared with patients treated with vehicle ointment (25.8% [41 of 159]). The percent improvement from baseline in eczema area and severity index scores was also significantly greater in tacrolimus-treated patients (54.8%) compared with vehicle-treated patients (20.8%). There was also a significant improvement in the percentage of total body surface area affected of tacrolimus-treated patients (50.5% reduction from baseline) compared with vehicle-treated patients (16.4%). Patient itch scores were significantly lower in tacrolimus-treated patients (2.1) versus vehicle-treated patients (3.7). Overall, the incidence of cutaneous adverse events reported was similar for both treatment groups. There was no significant difference in the incidence of burning or stinging between treatment groups. Significantly fewer tacrolimus-treated patients prematurely discontinued from the study because of a cutaneous adverse event in the treatment area or experienced increased itching and erythema at the application site. Conclusion. Monotherapy with tacrolimus ointment 0.03% is a safe and effective treatment alternative for pediatric patients with mild to moderate AD.

Original languageEnglish
JournalPediatrics
Volume116
Issue number3
DOIs
StatePublished - Sep 1 2005

Fingerprint

Tacrolimus
Atopic Dermatitis
Ointments
Pediatrics
Therapeutics
Body Surface Area
Eczema
Skin
Research Personnel
Safety
Incidence
Erythema
Pruritus
Double-Blind Method

Keywords

  • Atopic dermatitis
  • Pediatrics
  • Tacrolimus ointment
  • Topical immunomodulatory agents

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Tacrolimus ointment 0.03% is safe and effective for the treatment of mild to moderate atopic dermatitis in pediatric patients : Results from a randomized, double-blind, vehicle-controlled study. / Schachner, Lawrence A; Lamerson, Cindy; Sheehan, Mary P.; Boguniewicz, Mark; Mosser, Joy; Raimer, Sharon; Shull, Toni; Jaracz, Eileen.

In: Pediatrics, Vol. 116, No. 3, 01.09.2005.

Research output: Contribution to journalArticle

Schachner, Lawrence A ; Lamerson, Cindy ; Sheehan, Mary P. ; Boguniewicz, Mark ; Mosser, Joy ; Raimer, Sharon ; Shull, Toni ; Jaracz, Eileen. / Tacrolimus ointment 0.03% is safe and effective for the treatment of mild to moderate atopic dermatitis in pediatric patients : Results from a randomized, double-blind, vehicle-controlled study. In: Pediatrics. 2005 ; Vol. 116, No. 3.
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abstract = "Objective. This study was designed to compare the safety and efficacy of tacrolimus ointment 0.03{\%} with vehicle ointment for the treatment of mild to moderate atopic dermatitis (AD) in pediatric patients. Methods. A total of 317 patients (2-15 years of age) with mild to moderate AD were randomized to receive tacrolimus ointment or vehicle ointment twice daily in a 6-week, multicenter, double-blind study. Efficacy evaluations, including the Investigators' Global Atopic Dermatitis Assessment, eczema area and severity index, percentage of total body surface area affected, and patient assessment of itch occurred at baseline, day 4, and weeks 2, 4, and 6. Cutaneous adverse events were recorded to evaluate safety. Results. At the end of study, 50.6{\%} (80 of 158) of the patients were treated successfully with tacrolimus ointment based on Investigators' Global Atopic Dermatitis Assessment scores, a significant improvement compared with patients treated with vehicle ointment (25.8{\%} [41 of 159]). The percent improvement from baseline in eczema area and severity index scores was also significantly greater in tacrolimus-treated patients (54.8{\%}) compared with vehicle-treated patients (20.8{\%}). There was also a significant improvement in the percentage of total body surface area affected of tacrolimus-treated patients (50.5{\%} reduction from baseline) compared with vehicle-treated patients (16.4{\%}). Patient itch scores were significantly lower in tacrolimus-treated patients (2.1) versus vehicle-treated patients (3.7). Overall, the incidence of cutaneous adverse events reported was similar for both treatment groups. There was no significant difference in the incidence of burning or stinging between treatment groups. Significantly fewer tacrolimus-treated patients prematurely discontinued from the study because of a cutaneous adverse event in the treatment area or experienced increased itching and erythema at the application site. Conclusion. Monotherapy with tacrolimus ointment 0.03{\%} is a safe and effective treatment alternative for pediatric patients with mild to moderate AD.",
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AU - Sheehan, Mary P.

AU - Boguniewicz, Mark

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AB - Objective. This study was designed to compare the safety and efficacy of tacrolimus ointment 0.03% with vehicle ointment for the treatment of mild to moderate atopic dermatitis (AD) in pediatric patients. Methods. A total of 317 patients (2-15 years of age) with mild to moderate AD were randomized to receive tacrolimus ointment or vehicle ointment twice daily in a 6-week, multicenter, double-blind study. Efficacy evaluations, including the Investigators' Global Atopic Dermatitis Assessment, eczema area and severity index, percentage of total body surface area affected, and patient assessment of itch occurred at baseline, day 4, and weeks 2, 4, and 6. Cutaneous adverse events were recorded to evaluate safety. Results. At the end of study, 50.6% (80 of 158) of the patients were treated successfully with tacrolimus ointment based on Investigators' Global Atopic Dermatitis Assessment scores, a significant improvement compared with patients treated with vehicle ointment (25.8% [41 of 159]). The percent improvement from baseline in eczema area and severity index scores was also significantly greater in tacrolimus-treated patients (54.8%) compared with vehicle-treated patients (20.8%). There was also a significant improvement in the percentage of total body surface area affected of tacrolimus-treated patients (50.5% reduction from baseline) compared with vehicle-treated patients (16.4%). Patient itch scores were significantly lower in tacrolimus-treated patients (2.1) versus vehicle-treated patients (3.7). Overall, the incidence of cutaneous adverse events reported was similar for both treatment groups. There was no significant difference in the incidence of burning or stinging between treatment groups. Significantly fewer tacrolimus-treated patients prematurely discontinued from the study because of a cutaneous adverse event in the treatment area or experienced increased itching and erythema at the application site. Conclusion. Monotherapy with tacrolimus ointment 0.03% is a safe and effective treatment alternative for pediatric patients with mild to moderate AD.

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