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A multicenter trial of the efficacy and safety of 0.03% tacrolimus ointment for atopic dermatitis in Korea.
J Dermatolog Treat. 2004 Jan; 15(1):30-4.JD

Abstract

BACKGROUND

Atopic dermatitis is a chronically relapsing, common inflammatory skin disease, which significantly affects quality of life negatively in many respects. Topical steroids are the mainstay of atopic dermatitis treatment but they carry the risk of local side effects. A topical formulation of tacrolimus, a macrolide calcineurin inhibitor, has recently been developed.

OBJECTIVE

To evaluate the efficacy and safety of 0.03% tacrolimus ointment for the treatment of moderate to severe atopic dermatitis in Korea.

METHODS

An open, non-comparative, multi-center study with 4 weeks' follow-up was performed. A total of 180 patients (aged 2-57 years old) were enrolled. Tacrolimus ointment (0.03%) was applied to all involved areas twice daily. Efficacy was evaluated by an investigator's global assessment, the eczema area and severity index score, and by the patient's assessment of pruritus and clinical response at baseline, and after weeks 1, 2 and 4. Dermatology life quality index (DLQI), children's DLQI (CDLQI) and toddler's DLQI were assessed at baseline and at week 4. The safety assessment included monitoring all adverse events and clinical laboratory values.

RESULTS

All efficacy parameters were improved. The mean EASI (eczema area and severity index) score was 19.7 at baseline and reduced to 8.0 at the end of the study. Moderate improvement was observed by the investigator's global assessment after 4 weeks' treatment. A marked decrease of pruritus was observed, and mild or moderate improvement was observed by patients' global assessments after the treatment period. Significant benefits in terms of quality of life in adults and children with atopic dermatitis were obtained. The most common adverse events associated with tacrolimus treatment were transient skin burning sensation (45.3%) and pruritus (41.6%) at the site of application.

CONCLUSION

0.03% tacrolimus ointment should be considered effective and safe in both Korean children and adults with moderate to severe atopic dermatitis.

Authors+Show Affiliations

Department of Dermatology, Seoul National University Hospital, Korea.No affiliation info availableNo affiliation info availableNo affiliation info availableNo 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
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14754647

Citation

Won, C H., et al. "A Multicenter Trial of the Efficacy and Safety of 0.03% Tacrolimus Ointment for Atopic Dermatitis in Korea." The Journal of Dermatological Treatment, vol. 15, no. 1, 2004, pp. 30-4.
Won CH, Seo PG, Park YM, et al. A multicenter trial of the efficacy and safety of 0.03% tacrolimus ointment for atopic dermatitis in Korea. J Dermatolog Treat. 2004;15(1):30-4.
Won, C. H., Seo, P. G., Park, Y. M., Yang, J. M., Lee, K. H., Sung, K. J., Park, C. W., Kim, D. W., Chang, H. S., Won, Y. H., & Kim, K. H. (2004). A multicenter trial of the efficacy and safety of 0.03% tacrolimus ointment for atopic dermatitis in Korea. The Journal of Dermatological Treatment, 15(1), 30-4.
Won CH, et al. A Multicenter Trial of the Efficacy and Safety of 0.03% Tacrolimus Ointment for Atopic Dermatitis in Korea. J Dermatolog Treat. 2004;15(1):30-4. PubMed PMID: 14754647.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multicenter trial of the efficacy and safety of 0.03% tacrolimus ointment for atopic dermatitis in Korea. AU - Won,C H, AU - Seo,P G, AU - Park,Y M, AU - Yang,J M, AU - Lee,K H, AU - Sung,K J, AU - Park,C W, AU - Kim,D W, AU - Chang,H S, AU - Won,Y H, AU - Kim,K H, PY - 2004/2/3/pubmed PY - 2004/4/28/medline PY - 2004/2/3/entrez SP - 30 EP - 4 JF - The Journal of dermatological treatment JO - J Dermatolog Treat VL - 15 IS - 1 N2 - BACKGROUND: Atopic dermatitis is a chronically relapsing, common inflammatory skin disease, which significantly affects quality of life negatively in many respects. Topical steroids are the mainstay of atopic dermatitis treatment but they carry the risk of local side effects. A topical formulation of tacrolimus, a macrolide calcineurin inhibitor, has recently been developed. OBJECTIVE: To evaluate the efficacy and safety of 0.03% tacrolimus ointment for the treatment of moderate to severe atopic dermatitis in Korea. METHODS: An open, non-comparative, multi-center study with 4 weeks' follow-up was performed. A total of 180 patients (aged 2-57 years old) were enrolled. Tacrolimus ointment (0.03%) was applied to all involved areas twice daily. Efficacy was evaluated by an investigator's global assessment, the eczema area and severity index score, and by the patient's assessment of pruritus and clinical response at baseline, and after weeks 1, 2 and 4. Dermatology life quality index (DLQI), children's DLQI (CDLQI) and toddler's DLQI were assessed at baseline and at week 4. The safety assessment included monitoring all adverse events and clinical laboratory values. RESULTS: All efficacy parameters were improved. The mean EASI (eczema area and severity index) score was 19.7 at baseline and reduced to 8.0 at the end of the study. Moderate improvement was observed by the investigator's global assessment after 4 weeks' treatment. A marked decrease of pruritus was observed, and mild or moderate improvement was observed by patients' global assessments after the treatment period. Significant benefits in terms of quality of life in adults and children with atopic dermatitis were obtained. The most common adverse events associated with tacrolimus treatment were transient skin burning sensation (45.3%) and pruritus (41.6%) at the site of application. CONCLUSION: 0.03% tacrolimus ointment should be considered effective and safe in both Korean children and adults with moderate to severe atopic dermatitis. SN - 0954-6634 UR - https://www.unboundmedicine.com/medline/citation/14754647/A_multicenter_trial_of_the_efficacy_and_safety_of_0_03_tacrolimus_ointment_for_atopic_dermatitis_in_Korea_ L2 - http://www.tandfonline.com/doi/full/10.1080/09546630310020812 DB - PRIME DP - Unbound Medicine ER -