Korean J Dermatol.
2013 Nov;51(11):851-857.
An Open-Label, Single-Arm, Multicenter Trial of Tacrolimus Ointment 0.1% for the Treatment of Atopic Dermatitis in the Head and Neck
- Affiliations
-
- 1Department of Dermatology, Seoul National University Boramae Hospital, Seoul, Korea. sycho@snu.ac.kr
- 2Department of Dermatology, College of Medicine, Soonchunhyang University, Bucheon, Korea.
- 3Department of Dermatology, College of Medicine, Hallym University, Anyang, Korea.
- 4Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
- 5Department of Dermatology, Seoul National University Bundang Hospital, Seongnam, Korea.
Abstract
- BACKGROUND
Atopic dermatitis (AD) is a chronic or chronically relapsing, inflammatory, pruritic skin disease. Because tacrolimus ointment does not induce skin atrophy, it is especially indicated in delicate areas such as the face, intertriginous areas and anogenital region.
OBJECTIVE
With the aim of investigating the differences between the established clinical guidelines and actual treatment response, an open-label, non-comparative, multicenter clinical observational study was undertaken.
METHODS
One hundred and fifty-three patients with AD in the head and neck area were treated with topical tacrolimus 0.1% twice daily. Clinical evaluations were conducted at baseline, week 4 and week 8. Efficacy was assessed through the investigator's evaluation of the patients' individual signs (erythema, edema, oozing, excoriation, scaling, lichenification and fissuring) and symptoms (burning, pruritus and telangiectasia) using a 4-point grading system. The physician's and patient's global assessments and quality of sleep were also evaluated.
RESULTS
Among 153 enrolled patients, 25 (16.3%) were lost to follow-up, and 6 (3.9%) dropped out due to adverse events, leaving 79.7% of the population who completed the trial. Head and neck dermatitis was improved or cleared in 93.6% (week 4) and 94.4% (week 8) by physicians and in 92.1% (week 4) and 90.8% (week 8) by patients. Tacrolimus treatment improved the quality of sleep in head and neck dermatitis patients. Eighty-seven percent of the subjects were compliant, applying it at least 3 days per week. Burning sensation was the most frequently reported adverse event, followed by pruritus and aggravation of the lesion.
CONCLUSION
Tacrolimus ointment 0.1% is a safe and effective treatment option for atopic dermatitis of head and neck including eyelids.
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