Tags

Type your tag names separated by a space and hit enter

Superiority of tacrolimus 0.1% ointment compared with fluticasone 0.005% in adults with moderate to severe atopic dermatitis of the face: results from a randomized, double-blind trial.
Br J Dermatol. 2009 Aug; 161(2):427-34.BJ

Abstract

BACKGROUND

No specific data are available on tacrolimus ointment as a second-line treatment in adults with facial eczema.

OBJECTIVES

To compare tacrolimus 0.1% and fluticasone 0.005% ointments in adults with moderate to severe atopic dermatitis (AD) of the face in whom conventional treatment was ineffective or poorly tolerated.

METHODS

Patients were randomized to double-blind treatment of facial AD with twice-daily tacrolimus ointment (n = 288) or fluticasone ointment (n = 280) for 3 weeks or until clearance. After day 21, patients could continue without the study treatment, apply the same ointment once daily, or switch to the other medication twice daily, depending on lesion clearance and patient/physician satisfaction. The primary endpoint was the day-21 response [> or = 60% reduction in the modified Local Eczema and Severity Index (mLEASI) score]. Secondary endpoints included facial erythema and pruritus, global clinical response, treatment switching at day 21 and safety. RESULTS Response with tacrolimus ointment (93%) was superior to that with fluticasone (88%; P = 0.026). Improvements in mLEASI components were also greater with tacrolimus ointment. Facial erythema and pruritus improved in both groups. Global clinical response was rated 'marked improvement' or better in 88% and 79% of patients in the tacrolimus ointment and fluticasone groups, respectively. At day 21, 9% of patients switched from fluticasone to tacrolimus ointment, while 4.5% switched from tacrolimus ointment to fluticasone. Adverse events were more frequent with tacrolimus ointment as a result of the higher incidence of application-site skin burning sensation. Safety of both drugs was in line with their respective summary of product characteristics.

CONCLUSIONS

Tacrolimus 0.1% ointment has superior efficacy to fluticasone 0.005% ointment for twice-daily treatment of adults with moderate to severe facial AD in whom conventional therapy was inadequately effective or not tolerated. Tacrolimus 0.1% ointment is a safe and effective second-line treatment for the control of moderate to severe AD of the face.

Authors+Show Affiliations

Department of Dermatology, Military Hospital of Tunis, 1006 Tunis, Tunisia. nejib.doss@voila.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

19416227

Citation

Doss, N, et al. "Superiority of Tacrolimus 0.1% Ointment Compared With Fluticasone 0.005% in Adults With Moderate to Severe Atopic Dermatitis of the Face: Results From a Randomized, Double-blind Trial." The British Journal of Dermatology, vol. 161, no. 2, 2009, pp. 427-34.
Doss N, Reitamo S, Dubertret L, et al. Superiority of tacrolimus 0.1% ointment compared with fluticasone 0.005% in adults with moderate to severe atopic dermatitis of the face: results from a randomized, double-blind trial. Br J Dermatol. 2009;161(2):427-34.
Doss, N., Reitamo, S., Dubertret, L., Fekete, G. L., Kamoun, M. R., Lahfa, M., & Ortonne, J. P. (2009). Superiority of tacrolimus 0.1% ointment compared with fluticasone 0.005% in adults with moderate to severe atopic dermatitis of the face: results from a randomized, double-blind trial. The British Journal of Dermatology, 161(2), 427-34. https://doi.org/10.1111/j.1365-2133.2009.09143.x
Doss N, et al. Superiority of Tacrolimus 0.1% Ointment Compared With Fluticasone 0.005% in Adults With Moderate to Severe Atopic Dermatitis of the Face: Results From a Randomized, Double-blind Trial. Br J Dermatol. 2009;161(2):427-34. PubMed PMID: 19416227.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Superiority of tacrolimus 0.1% ointment compared with fluticasone 0.005% in adults with moderate to severe atopic dermatitis of the face: results from a randomized, double-blind trial. AU - Doss,N, AU - Reitamo,S, AU - Dubertret,L, AU - Fekete,G L, AU - Kamoun,M-R, AU - Lahfa,M, AU - Ortonne,J-P, Y1 - 2009/04/16/ PY - 2009/5/7/entrez PY - 2009/5/7/pubmed PY - 2009/12/25/medline SP - 427 EP - 34 JF - The British journal of dermatology JO - Br. J. Dermatol. VL - 161 IS - 2 N2 - BACKGROUND: No specific data are available on tacrolimus ointment as a second-line treatment in adults with facial eczema. OBJECTIVES: To compare tacrolimus 0.1% and fluticasone 0.005% ointments in adults with moderate to severe atopic dermatitis (AD) of the face in whom conventional treatment was ineffective or poorly tolerated. METHODS: Patients were randomized to double-blind treatment of facial AD with twice-daily tacrolimus ointment (n = 288) or fluticasone ointment (n = 280) for 3 weeks or until clearance. After day 21, patients could continue without the study treatment, apply the same ointment once daily, or switch to the other medication twice daily, depending on lesion clearance and patient/physician satisfaction. The primary endpoint was the day-21 response [> or = 60% reduction in the modified Local Eczema and Severity Index (mLEASI) score]. Secondary endpoints included facial erythema and pruritus, global clinical response, treatment switching at day 21 and safety. RESULTS Response with tacrolimus ointment (93%) was superior to that with fluticasone (88%; P = 0.026). Improvements in mLEASI components were also greater with tacrolimus ointment. Facial erythema and pruritus improved in both groups. Global clinical response was rated 'marked improvement' or better in 88% and 79% of patients in the tacrolimus ointment and fluticasone groups, respectively. At day 21, 9% of patients switched from fluticasone to tacrolimus ointment, while 4.5% switched from tacrolimus ointment to fluticasone. Adverse events were more frequent with tacrolimus ointment as a result of the higher incidence of application-site skin burning sensation. Safety of both drugs was in line with their respective summary of product characteristics. CONCLUSIONS: Tacrolimus 0.1% ointment has superior efficacy to fluticasone 0.005% ointment for twice-daily treatment of adults with moderate to severe facial AD in whom conventional therapy was inadequately effective or not tolerated. Tacrolimus 0.1% ointment is a safe and effective second-line treatment for the control of moderate to severe AD of the face. SN - 1365-2133 UR - https://www.unboundmedicine.com/medline/citation/19416227/Superiority_of_tacrolimus_0_1_ointment_compared_with_fluticasone_0_005_in_adults_with_moderate_to_severe_atopic_dermatitis_of_the_face:_results_from_a_randomized_double_blind_trial_ L2 - https://doi.org/10.1111/j.1365-2133.2009.09143.x DB - PRIME DP - Unbound Medicine ER -