Successful treatment of resistant facial lesions of atopic dermatitis with 0.1% FK506 ointment

Aoyama, Hiroaki; Tabata, Noriko; Tanaka, Mari; Uesugi, Yuuki; Tagami, Hachiro

doi:10.1111/j.1365-2133.1995.tb02691.x

Cited by 106 publications

(59 citation statements)

References 14 publications

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“…To prepare the 0.1% ointment, the content of tacrolimus capsules (total 100 mg) was mixed with 100 g of hydrophilic petrolatum (white petrolatum composed of 8% bleached beeswax, 3% stearyl alcohol and 3% cholesterol). The placebo ointment of tacrolimus was only made of 100 g of hydrophilic petrolatum without tacrolimus [17]. All treatments were administered by a person unaware who was participating in the study.…”

Section: Patientsmentioning

confidence: 99%

Comparing tacrolimus ointment and oral cyclosporine in adult patients affected by atopic dermatitis: a randomized study

Pacor

Lorenzo

Martinelli

et al. 2004

Clin Experimental Allergy

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SummaryBackground Atopic dermatitis (AD) is a chronic allergic inflammatory disease, which manifests itself with eczematous skin lesions. Objective We compared the clinical efficacy of tacrolimus ointment (0.1%) given twice a day and oral cyclosporine (3 mg/kg) given once daily. Rescue medication for itching included cetirizine 10-20 mg (equal to one or two tables). Methods Thirty patients, aged 13-45 years (mean AE SD 27.1 AE 10.9), with a history of moderateto-severe AD were randomized to treatments, 15 patients for each treatments. Assessment of efficacy was based on SCORAD, on scores of daily itching, erythema, interference with sleep, due to the skin condition and days without use of cetirizine tablets. SCORAD, measured on a scale (0-103), was evaluated before treatment (0) and at 7, 14, 21, 28, 35 and 42 days after treatment. Similarly, the means of daily symptoms, on a scale (0-3), were evaluated before the treatment (0) and at 7, 14, 21, 28, 35 and 42 days after treatment; finally, on day without use of cetirizine tablets. The safety of the study treatments was assessed through haematologic, biochemical and urinary testing and on systolic and diastolic blood pressures and heart rate measurements. Results SCORAD decreased in the two treatment groups 14 days after the beginning of the period study. However, the patients in tacrolimus ointment group reported significantly lower SCORAD than those treated with oral cyclosporine. Overall SCORAD, as assessed by the area under the curve (AUC) day 0-42 (score/day), was significantly lower in the tacrolimus ointment group when compared with oral cyclosporine (Po0.001). Similarly, AUC day 0-42 (score/day) for itching, erythema and number of nights without interference with the sleep due to skin condition were significantly lower in the group of patients treated with tacrolimus compared with those treated with cyclosporine (P 5 0.003, 0.005 and 0.01, respectively). As regards the use of rescue medication, expressed by median of number of days without use of anti-H 1 , it was significantly lower in the group treated with tacrolimus (82.5) than in the cyclosporine group (76.5) (P 5 0.03). There were no appreciable changes in haematological and biochemical indices, in both treatments groups. Conclusion The results of this comparative study demonstrate that tacrolimus ointment twice daily and cyclosporine administered orally once daily are effective on SCORAD, daily symptoms and anti-H 1 rescue. When we compared tacrolimus and cyclosporine there was a faster onset of action in the group treated with tacrolimus. The two drugs presented the same safety. However, these data support the preferential use of topical tacrolimus 0.1% in AD, because cyclosporine has potential side-effects.

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Section: Patientsmentioning

confidence: 99%

Comparing tacrolimus ointment and oral cyclosporine in adult patients affected by atopic dermatitis: a randomized study

Pacor

Lorenzo

Martinelli

et al. 2004

Clin Experimental Allergy

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“…In addition to epidermal and dermal atrophy, barrier dysfunction of the stratum corneum (SC) also occurs. Recently, topical tacrolimus ointment has been introduced as an effective treatment for the facial lesions of AD [6, 7, 8]. However, information about its short-term as well as long-term effects on normal human skin is still limited.…”

Section: Introductionmentioning

confidence: 99%

Comparison of the Effects of Daily Applications between Topical Corticosteroid and Tacrolimus Ointments on Normal Skin: Evaluation with Noninvasive Methods

Kikuchi

Tagami

2002

Dermatology

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Objective: To evaluate the skin changes of the neck of normal individuals after repeated applications of moderate-strength corticosteroid or tracrolimus ointment for 3 weeks by use of noninvasive biophysical measurements. Methods: A 0.12% betamethasone-17-valerate ointment or a 0.1% tacrolimus ointment was applied to the right side of the neck of 8 adult volunteers twice daily for 3 weeks together with control petrolatum applied to the left side of the neck for comparison. Biophysical skin measurements were performed on the neck skin before, 1 and 3 weeks after the start of the treatment and 1 week after the cessation of the treatment. Results: A decrease in hygroscopicity and water-holding capacity of the stratum corneum (SC) when evaluated with the in vivo water sorption-desorption test was found on the corticosteroid-ointment-treated side after 3 weeks of the treatment as compared with the petrolatum-treated side. The erythematous reaction to a topically applied 0.1% aqueous solution of methyl nicotinate, a vasodilator, appeared more slowly on the corticosteroid-ointment-treated skin than on the control skin. No such changes were observed on the skin treated with 0.1% tacrolimus ointment. Conclusion: Tacrolimus appears to cause few if any functional changes in the SC of healthy human skin because of its poor permeability into skin with an intact barrier function.

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“…A Japanese clinical open study demonstrated a similar potency of tacrolimus ointment to that of highly concentrated corticosteroid ointment [18]. Moreover, topical tacrolimus treatment of face and neck lesions is not associated with skin atrophy or telangiectasias [19, 20, 21]. These results suggest that tacrolimus presents an attractive therapeutic option in the treatment of face and neck AD, which can otherwise be difficult to manage [22].…”

Section: Introductionmentioning

confidence: 92%

Safe and Effective Treatment of Refractory Facial Lesions in Atopic Dermatitis Using Topical Tacrolimus following Corticosteroid Discontinuation

et al. 2001

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Background: Topical corticosteroids are commonly applied in atopic dermatitis (AD) treatment. However, their chronic use may be associated with significant side effects at the application site. Skin atrophy and other undesirable effects are frequently seen after long-term corticosteroid treatment. In addition, when application of corticosteroids is discontinued, a rebound phenomenon in the facial lesions can occur within several days. Topical tacrolimus, an immunosuppressant currently used to prevent rejection after solid-organ transplantation, presents a potential alternative therapeutic agent for AD. Objective: The present study is the first trial designed to evaluate the efficacy and safety of topically applied tacrolimus ointment after corticosteroid discontinuation without a washout phase in severe, long-term facial AD. Patients/Methods: Forty-seven patients with facial refractory AD were recruited, of whom 38 had undergone topical corticosteroid treatment for at least 4 weeks before enrollment (group 1) and the other 9 had not received steroid treatment (group 2). All 47 patients received 0.1% tacrolimus ointment, and the severity index and pruritus score were assessed as an AD clinical activity index every week and compared with baseline data. Results: Both the severity index and pruritus score improved significantly in group 1 after 1 and 2 weeks of application (p < 0.01, respectively). Group 2 showed the greatest improvement at 4 weeks (p < 0.05). In this trial, none of the patients experienced a rebound phenomenon associated with tacrolimus treatment. A transient sensation of burning at the application site was the only adverse event in 31 of the 47 (66%) enrolled patients, but this condition improved after several days. Spectrophotometric assessment of the facial lesion following treatment revealed significant improvement in group 1 (p < 0.05). Conclusion: The present results indicate that topical tacrolimus treatment following corticosteroid discontinuation is safe and effective in refractory facial AD.

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Successful treatment of resistant facial lesions of atopic dermatitis with 0.1% FK506 ointment

Cited by 106 publications

References 14 publications

Comparing tacrolimus ointment and oral cyclosporine in adult patients affected by atopic dermatitis: a randomized study

Comparing tacrolimus ointment and oral cyclosporine in adult patients affected by atopic dermatitis: a randomized study

Comparison of the Effects of Daily Applications between Topical Corticosteroid and Tacrolimus Ointments on Normal Skin: Evaluation with Noninvasive Methods

Safe and Effective Treatment of Refractory Facial Lesions in Atopic Dermatitis Using Topical Tacrolimus following Corticosteroid Discontinuation

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