Ann Dermatol.  2012 May;24(2):144-150.

A Randomized, Open-Label, Multicenter Trial of Topical Tacrolimus for the Treatment of Pruritis in Patients with Atopic Dermatitis

• Takeuchi S
• Saeki H
• Tokunaga S
• Sugaya M
• Ohmatsu H
• Tsunemi Y
• Torii H
• Nakamura K
• Kawakami T
• Soma Y
• Gyotoku E
• Hide M
• Sasaki R
• Ohya Y
• Kido M
• Furue M

Abstract

BACKGROUND
Pruritis caused by atopic dermatitis (AD) is not always well controlled by topical corticosteroid therapy, but use of tacrolimus often helps to soothe such intractable pruritis in clinical settings.
OBJECTIVE
To determine the anti-pruritic efficacy of topical tacrolimus in treating AD in induction and maintenance therapy.
METHODS
Prior to the study, patients were randomly allocated into two groups, induction therapy followed by tacrolimus monotherapy maintenance, and induction therapy followed by emollient-only maintenance. In the induction therapy, the patients were allowed to use topical tacrolimus and emollients in addition to a low dose (<10 g/week) of topical steroids. Patients showing relief from pruritis were allowed to proceed to maintenance therapy. Recurrence of pruritis in maintenance therapy was examined as a major endpoint.
RESULTS
Two-thirds of patients (44/68; 64.7%) showed relief from pruritis after induction therapy. Pruritis recurred in 23.8% (5/21) of the tacrolimus monotherapy group and in 100% (21/21) of the emollient group during maintenance period, a difference that was statistically significant.
CONCLUSION
Use of topical tacrolimus is effective in controlling pruritis of AD compared to emollient.

Keyword

Atopic dermatitis; Maintenance therapy; Pruritis; Randomized trial; Tacrolimus

MeSH Terms

Dermatitis, Atopic
Emollients
Humans
Pruritus
Recurrence
Steroids
Tacrolimus
Emollients
Steroids
Tacrolimus

Figure

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  Fig. 1 Flow diagram showing subjects' progress. Patients were advance-allocated after registration, received introduction therapy (add-on tacrolimus therapy), and the responders to the introduction therapy proceeded into maintenance therapy. There were several dropouts and one refusal during the study. VAS: visual analogue scale.

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  Fig. 2 Change in visual analogue scale (VAS)-itch score and disease severity after add-on tacrolimus therapy. (A) Pruritis (mean VAS-itch score - standard deviation) reduced after add-on topical tacrolimus therapy. (B) There was no statistical difference in mean VAS-itch score between responders and non-responders before the add-on therapy. (C) There was a significant decrease in VAS-itch score in responders after the add-on therapy. (D) SCORing Atopic Dermatitis (SCORAD) score reduced after the add-on topical tacrolimus therapy.

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  Fig. 3 Cumulative recurrence of pruritis in maintenance therapy. Tacrolimus monotherapy group (solid line) showed significantly much lower recurrence of pruritis compared to that of the emollient group (dotted line).

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  Fig. 4 Efficacy of tacrolimus monotherapy in maintenance therapy. The emollient group showed more pruritis than the tacrolimus monotherapy group at the end of maintenance therapy. VAS: visual analogue scale.

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  Fig. 5 Change of SCORing Atopic Dermatitis (SCORAD) in induction therapy between treatment-responding (blue circle) and non-responding patients (red circle) in induction therapy. Forty-three treatment-responding patients showed significantly reduced SCORAD compared to that of 7 non-responding patients in induction therapy as assessed by analysis of covariance (p=0.001).

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