tacrolimus and Eczema

Topics: Administration, Topical; Animals; Antigens, Dermatophagoides; Child; Child, Preschool; Cyclosporine; Dermatitis, Atopic; Desensitization, Immunologic; Eczema; Edema; Humans; Immunoglobulin E; Male; Pyroglyphidae; Tacrolimus

Swollen lower limb is a diagnostic challenge for a physician. Common conditions causing swelling of lower extremities are chronic venous insufficiency and abnormalities in lymph drainage. Stasis dermatitis and lymphedema are manifestations of these defects. The most important therapy of both stasis dermatitis and lymphedema is adequate compression therapy. Patient education is important in order to achieve good compliance with compression therapy. The mainstay therapies of skin eczema are corticosteroids and tacrolimus ointment. Patients with stasis dermatitis have a higher risk for contact sensitization, which is important to remember when prescribing topical treatments.

Topics: Adrenal Cortex Hormones; Diagnosis, Differential; Eczema; Humans; Immunosuppressive Agents; Leg Dermatoses; Lymphedema; Stockings, Compression; Tacrolimus; Venous Insufficiency

Pimecrolimus was developed as an alternative to topical corticosteroids for treating eczema (atopic dermatitis) but its efficacy and safety compared with existing treatments remains unclear.. To assess the effects of topical pimecrolimus for treating eczema.. We searched the Cochrane Skin Group Specialised Register (to October 2006), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2006), MEDLINE (from 2003 to October 2006), and EMBASE (from 2005 to October 2006). We also contacted researchers and manufacturers in the field.. Randomised controlled trials of 1.0% topical pimecrolimus used twice daily compared against other topical comparators for treating eczema.. Two authors independently examined each retrieved study for eligibility and extracted data for efficacy, tolerability and safety. A random-effects model was used to estimate the pooled risk ratios (RRs) and 95% confidence intervals (95% CIs).. We included 31 trials (8019 participants) in the analysis. In short-term (/=6 months), pimecrolimus was significantly better than vehicle in preventing flares (9 trials, 3091 participants, RR 1.47, 95% CI 1.32 to 1.64 at six months) and in improving quality of life. Pimecrolimus was significantly less effective than two topical corticosteroids, i.e. 0.1% triamcinolone acetonide for investigators' global assessment (1 trial, 658 participants, RR 0.75, 95% CI 0.67 to 0.83) and 0.1% betamethasone valerate for participants' global assessment (1 trial, 87 participants, RR 0.61, 95% CI 0.45 to 0.81) at three weeks. Pimecrolimus was also associated with significantly more overall withdrawals and skin burning. None of the trials reported on key adverse effects such as thinning of skin. Pimecrolimus was significantly less effective than 0.1% tacrolimus for investigators' global assessment at six weeks (RR 0.58, 95% CI 0.46 to 0.74) and led to more withdrawals due to lack of efficacy (RR 2.37, 95% CI 1.10 to 5.08) based on two trials involving 639 participants, but there was no significant difference in proportions of participants experiencing any adverse events.. Topical pimecrolimus is less effective than moderate and potent corticosteroids and 0.1% tacrolimus. The therapeutic role of topical pimecrolimus is uncertain due to the absence of key comparisons with mild corticosteroids.

Topics: Administration, Topical; Adolescent; Adrenal Cortex Hormones; Adult; Child; Child, Preschool; Dermatologic Agents; Eczema; Humans; Immunosuppressive Agents; Infant; Quality of Life; Randomized Controlled Trials as Topic; Tacrolimus

Topical corticosteroids (TCC) have significantly shaped dermatological therapy for five decades. A few months ago the TCC were joined by competition, the topical inhibitors of calcineurin (TIC), wrongly termed topical immunomodulators. The present paper reviews the pharmacological effects and clinical efficacy of TIC, compares the risks, benefits and costs of those two groups of topical drugs and develops a position on the use of TIC. While TIC have ushered in a new era of topical anti-inflammatory therapy, the age of TCC is far from over.

Topics: Acute Disease; Administration, Topical; Anti-Inflammatory Agents; Calcineurin Inhibitors; Cyclosporins; Dermatitis, Atopic; Eczema; Facial Dermatoses; Glucocorticoids; Humans; Immunosuppressive Agents; Neurodermatitis; Psoriasis; Pyoderma Gangrenosum; Risk Factors; Skin Diseases; Tacrolimus

Chronic inflammatory skin disorders, such as atopic eczema, can cause considerable impairment of life quality. Their treatment is mainly driven by systemic or topical glucocorticosteroids which have the risk of many side effects. Recently, immunosuppressive macrolides which act via the inhibition of cytokine expression in T-lymphocytes have been shown to exert good therapeutic potency in inflammatory skin disorders. Cyclosporin, widely used in transplantation medicine, is also effective in psoriasis and atopic eczema but is not suitable for topical treatment. Tacrolimus (FK506) has been found to be 10-100 times more potent than cyclosporin and to penetrate skin much better due to a lower molecular weight. Initial clinical investigations have shown efficacy of topical tacrolimus in patients with atopic eczema. Large multi-centre studies have proven that long-term therapy with 0.03% and 0.1% tacrolimus ointment reveals effectiveness and safety both in adults and in children with severe atopic eczema. A burning sensation at the site of application is the most frequently observed local side effect. Relevant systemic adverse events were not detected. In Japan and the US, the drug is already licensed for the treatment of atopic eczema. The European admission for the pharmaceutical market is expected in the year 2002. Tacrolimus represents a milestone in topical therapy of inflammatory skin disorders which has so far been dominated by corticosteroid formulations and gives hope for the development of further topical immunosuppressive agents of its class in the future.

Topics: Administration, Oral; Administration, Topical; Adult; Child; Chronic Disease; Clinical Trials as Topic; Contraindications; Dermatitis; Drug Interactions; Drug Tolerance; Eczema; Humans; Immunosuppressive Agents; Molecular Structure; Tacrolimus

Topics: Administration, Cutaneous; Anti-Inflammatory Agents; Drug Administration Schedule; Eczema; Evidence-Based Medicine; Glucocorticoids; Humans; Immunosuppressive Agents; Randomized Controlled Trials as Topic; Tacrolimus

Childhood atopic dermatitis (AD) is often followed by other atopic comorbidities such as asthma.. To compare the effectiveness of topical tacrolimus (TAC) and topical corticosteroids (TCSs) and their impact on airway inflammation and bronchial hyperresponsiveness in patients with paediatric AD.. This was a 3-year randomized open-label comparative follow-up study of 152 1-3-year-old children with moderate-to-severe AD (trial registration: EudraCT2012-002412-95). Frequent study visits including clinical examinations, laboratory investigations (total IgE, specific IgEs, blood eosinophils), skin prick and respiratory function tests to assess airway inflammation and bronchial hyperresponsiveness (exhaled nitric oxide, airway responsiveness to exercise and methacholine) were performed.. Changes in eczema parameters at 36 months were similar in the TCS and TAC groups for mean body surface area (BSA) difference 1.4 [95% confidence interval (CI) -1.48 to 4.19); P = 0.12], mean Eczema Area and Severity Index (EASI) difference 0.2 (95% CI -1.38 to 1.82; P = 0.2), mean Investigator's Global Assessment (IGA) difference, 0.3 (95% CI -0.12 to 0.67; P = 0.12) and mean transepidermal water loss (TEWL) difference at the eczema site, -0.3 (95% CI -4.93 to 4.30; P = 0.96) and at the control site, 1.4 (95% CI -0.96 to 3.60, P = 0.19). The control-site TEWL increased more towards the end of follow-up in the TCS vs. TAC group (mean change difference -4.2, 95% CI -8.14 to -0.29; P = 0.04). No significant impact on development of airway inflammation or bronchial hyperresponsiveness occurred in early effective eczema-treatment responders vs. others ('early' vs. 'other' response was defined as the difference in treatment response to airway outcomes in BSA, EASI or IGA at 3 months).. Children with moderate-to-severe AD benefit from long-term treatment with TCS or TAC. There were no significant differences in treatment efficacy. No differences in the impact on airways occurred between early effective treatment responders vs. others.

Topics: Adrenal Cortex Hormones; Child; Child, Preschool; Dermatitis, Atopic; Double-Blind Method; Eczema; Follow-Up Studies; Humans; Immunoglobulin A; Inflammation; Severity of Illness Index; Tacrolimus; Treatment Outcome

We collected evidence and safety data for topical tacrolimus in small children with atopic dermatitis (AD) and compared the usage with topical corticosteroid.. This was an interim analysis of 75 patients (55% female) at 1 year of an ongoing 3-year randomised open-label comparative follow-up study of topical tacrolimus vs corticosteroid treatment. One- to three-year-old children with moderate-to-severe eczema referred to the Skin and Allergy Hospital in Helsinki, Finland, were enrolled.. Efficacy parameters, the Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), transepidermal water loss (TEWL), eczema area, serum total immunoglobulin E (IgE) and the blood eosinophil count, showed improvement in both groups during the study. However, patients with signs of early sensitisation at baseline (elevated serum total IgE, elevated eosinophil count, positive prick tests or specific IgEs to aero or food allergens) had statistically significantly lower TEWL at the eczema site and a smaller eczema area at 12 months in the tacrolimus group. No severe adverse effects were seen during the treatment.. Children with AD and signs of early sensitisation appeared to benefit more from early tacrolimus than corticosteroid treatment. Small children may need stronger but nevertheless safe ointment options when treating moderate-to-severe AD.

Topics: Administration, Topical; Adrenal Cortex Hormones; Child, Preschool; Dermatitis, Atopic; Eczema; Female; Finland; Follow-Up Studies; Humans; Immunosuppressive Agents; Infant; Male; Tacrolimus; Treatment Outcome

There is no consensus on the use of soap in skin care for atopic dermatitis in Japan. Thus, this study aimed to evaluate the efficacy of soap to maintain eczema remission in atopic dermatitis patients during the fall-winter period in Japan.. This assessor-blinded, pragmatic randomized, non-inferiority study enrolled atopic dermatitis patients whose eczema was controlled by regular steroid ointment application less than or equal to 2 days / week (tacrolimus ointment was permitted). For 8 ± 3 weeks, participants washed their upper and lower limbs on one side with soap (soap side) and on the other side with water alone (water side). The primary outcome was an Eczema Area and Severity Index score at week 8 ± 3.. Twenty-nine participants were analyzed. The Eczema Area and Severity Index scores at week 8 ± 3 of the water and soap sides were 0.0 (0.0-0.4) and 0.0 (0.0-0.4), respectively (P = 0.18). The difference between both sides was -0.02 (-0.11-0.08), and the limits of the 95% confidence interval did not reach the prespecified non-inferiority margin. The average Patient-Oriented Eczema Measure score was 1.27 ± 1.7 and 1.32 ± 1.8 for the water and soap sides, respectively (P = 0.92). The total number of additional steroid ointment applications was four (0-20) times and six (0-23) times, respectively (P = 0.98). Participants were categorized according to self-assessments of the usefulness of soap, with 2, 24, and 3 participants in the water-effective, invariant, and soap-effective groups, respectively.. For children with controlled atopic dermatitis, washing with water alone was not inferior to washing with soap for maintaining remission of eczema during the fall-winter period in Japan.

Topics: Child; Child, Preschool; Dermatitis, Atopic; Eczema; Female; Humans; Immunosuppressive Agents; Infant; Japan; Male; Remission Induction; Seasons; Severity of Illness Index; Skin Care; Soaps; Tacrolimus; Treatment Outcome; Water

Patients tend to apply topical medications less frequently, in improper amounts. Not only frequency but also application amount may influence treatment outcome. However, studies on relationship between application amount and objective treatment outcome have rarely been conducted.. To assess efficacy of topical agent according to application amount in adult patients, using the finger-tip unit method.. The efficacy of 0.1% topical tacrolimus in adult patients with localised atopic dermatitis was assessed using EASI, TIS, IGA, and PGA scores at baseline, follow-up. Adherence in amount was evaluated after 2 weeks of treatment using the ratio of the actual amount applied to the expected amount applied (A/E).. Twenty-seven patients (20.93%) used topical tacrolimus in proper amounts (A/E: 0.8-1.2). However, 86 patients (66.67%) underused topical tacrolimus; 16 (12.40%) patients overused topical tacrolimus. Decreases in EASI scores between baseline and 2 weeks of follow-up in each group (under-amount, proper amount, over-amount) were 1.64, 4.65 and 4.21, respectively. Treatment efficacy increased in accordance with application amount. Further, TIS, IGA, PGA, VAS for Itch and DLQI scores improved concomitantly, exhibiting similar tendencies.. Application amount of topical agent is important in increasing treatment efficacy in adult patients with atopic dermatitis.

Topics: Administration, Topical; Adult; Eczema; Female; Humans; Immunosuppressive Agents; Male; Medication Adherence; Middle Aged; Quality of Life; Severity of Illness Index; Tacrolimus; Treatment Outcome; Young Adult

Tacrolimus ointment is effective for treatment of moderate to severe atopic dermatitis (AD) in children aged ≥2 years (Br J Dermatol, 2004; 150: 554). Here, efficacy and tolerability of tacrolimus 0.03% ointment were evaluated in 50 infants aged <2 years at start of treatment.. Infants with AD previously enrolled in a tacrolimus ointment pharmacokinetics trial were eligible for a 24-month open-label phase II study. Tacrolimus 0.03% ointment was applied to affected areas until clearance. In cases of exacerbation or clinical worsening, patients restarted treatment.. Mean ± SD Eczema Area and Severity Index (EASI) score improved, from 11.2 ± 10.5 baseline to 2.6 ± 4.1 at endpoint (24 months); mean affected body surface area decreased from 25.2 ± 21.1% to 5.1 ± 9.0%, with improvement on all items of the Physicians' Assessment of Individual Signs. The Physicians' Global Evaluation of Clinical Response showed a result of "cleared"/"excellent" for 63.3% of patients; 85.7% of parents/guardians assessed symptoms as "much better." Treatment was well tolerated, with common, nonserious respiratory infections and gastroenteritis the most frequently reported adverse events. The most common application-site events were infections and pruritus. Over 98% of blood samples showed tacrolimus concentrations <1.0 ng/ml; >40% showed concentrations below the lower limit of quantification (0.0250 ng/ml).. Over a period of two years, tacrolimus 0.03% ointment was associated with substantial clinical improvement of AD in infants aged <2 years. Treatment tolerability was similar to that seen in older children.

Topics: Dermatitis, Atopic; Eczema; Female; Humans; Immunosuppressive Agents; Infant; Male; Ointments; Tacrolimus; Treatment Outcome

Topical pimecrolimus may maintain remissions of atopic dermatitis (AD) by inhibiting subclinical inflammation.. To evaluate clinical and cytological effects of pimecrolimus in topical corticosteroid-treated and resolved AD lesions.. Patients (n=67) with resolved AD lesions were randomized to 3-week double-blind treatment with either pimecrolimus cream 1% or vehicle cream. Outcome measures were reduction in Eczema Area and Severity Index (EASI) and number of leukocytes in skin biopsies in all randomized patients who were evaluable at the end of study.. The proportion of patients with a localized EASI<2 at the end of study was higher with pimecrolimus cream 1% than with vehicle cream (73.5 vs. 39.4%, respectively). There was a significant decrease in the number of infiltrating CD45+ cells in pimecrolimus cream 1% compared with placebo cream (-88.2 vs. 43.2 cells/mm(2), respectively, p=0.047) and a slight but nonsignificant reduction in the number of dermal dendritic cells, Langerhans cells, T cells and macrophages with pimecrolimus versus vehicle cream.. This was an exploratory study.. Topical pimecrolimus was effective at maintaining betamethasone-17α-valerate-induced AD remission by inhibiting recurrences of the inflammatory infiltrate in the skin.

Topics: Adult; Aged; Betamethasone Valerate; Dermatitis, Atopic; Dermatologic Agents; Double-Blind Method; Eczema; Glucocorticoids; Humans; Leukocyte Count; Male; Middle Aged; Remission Induction; Secondary Prevention; Severity of Illness Index; Statistics, Nonparametric; Tacrolimus; Young Adult

Impaired skin integrity in patients with Netherton syndrome (NS) results in significant systemic absorption of topically applied medications. Some have advocated the administration of pimecrolimus, 1%, topical cream for the treatment of patients with NS. Insufficient data exist with regard to its safety, systemic absorption, and efficacy.. An exploratory study was conducted involving 3 children with NS who received twice-daily application of pimecrolimus, 1%, cream over 18 months. There were no notable abnormalities in hematologic or chemistry profiles. Blood levels of pimecrolimus ranged from 0.625 to 7.08 ng/mL, with peak levels reached during the first month in all 3 patients. Dramatic reductions were observed in the Netherton Area and Severity Assessment, Eczema Area and Severity Index, Investigator Global Evaluation of Disease, and pruritus scores compared with baseline levels.. Use of pimecrolimus, 1%, cream was well tolerated and demonstrated marked improvements in nearly all of the parameters evaluated. Patients treated with pimecrolimus responded rapidly, within the first month of treatment, and improvement persisted throughout the study period. In adult patients receiving oral pimecrolimus, blood levels as high as 54 ng/mL for 3 months have not shown clinically significant immunosuppression. Absorption of pimecrolimus, 1%, cream was detectable, but levels were much lower than expected even when applied to 50% of total body surface area. Larger studies are warranted to determine the safety and efficacy of pimecrolimus, 1%, cream in the treatment of NS.. clinicaltrials.gov Identifier: NCT00208026.

Topics: Administration, Topical; Calcineurin Inhibitors; Child; Dermatologic Agents; Dose-Response Relationship, Drug; Drug Administration Schedule; Eczema; Female; Follow-Up Studies; Humans; Netherton Syndrome; Ointments; Quality of Life; Skin; Skin Absorption; Tacrolimus; Time Factors; Treatment Outcome

Atopic dermatitis (AD) is most prevalent in areas of reduced skin barrier reserve, like face and neck, especially in children. Treatment with topical corticosteroids (TCS) is limited due to heightened risk of treatment-associated side-effects, thus necessitating alternative AD therapies.. The primary study objective was to determine the efficacy of pimecrolimus cream 1% in children with mild-moderate facial AD dependent on/intolerant of TCS. Secondary objectives included effects on overall Eczema Area and Severity Index (EASI), head/neck EASI, pruritus severity and time to clearance of facial AD.. A multicentre, double-blind (DB) study of < or = 6 weeks, followed by a 6-week, open-label (OL) phase was conducted. Two hundred patients (aged 2-11 years) were randomized 1:1 to pimecrolimus cream 1% (n = 99) or vehicle (n = 101) twice daily until clearance of facial AD or for a maximum of 6 weeks (DB phase). Sixteen patients receiving vehicle were allowed to switch to the OL phase at day 22.. Significantly more pimecrolimus-treated vs. vehicle-treated patients were cleared/almost cleared of facial AD (Investigators' Global Assessment 0/1): 74.5% vs. 51.0%, P < 0.001 (day 43) [57.1% vs. 36.0%, P = 0.004 (day 22)]. Median time to clearance was 22.0 vs. 43.0 days (pimecrolimus vs. vehicle, respectively). Statistically significant differences for pimecrolimus vs. vehicle were also seen on head/neck EASI, overall EASI, and head/neck pruritus scores. Adverse events were mainly mild-moderate, occurring with similar frequency in both treatment groups.. In children with facial dermatitis intolerant of/dependent on TCS, pimecrolimus cream 1% effectively controls eczema and pruritus and is well tolerated.

Topics: Adrenal Cortex Hormones; Child; Child, Preschool; Dermatitis, Atopic; Dermatologic Agents; Double-Blind Method; Eczema; Facial Dermatoses; Female; Humans; Male; Pharmaceutical Vehicles; Pruritus; Severity of Illness Index; Tacrolimus; Treatment Outcome

Pimecrolimus cream 1% is an effective treatment for atopic eczema. The aim was to investigate its efficacy in asteatotic eczema, a skin disease similar to atopic eczema and its associated dry skin and itching.. Single-centre, randomized, double-blind, vehicle controlled study in 40 patients with asteatotic eczema. Efficacy was assessed by eczema area and severity index (EASI), investigators global assessment (IGA), patient's self-assessment, and pruritus severity.. After 4 weeks of treatment, EASI, the primary efficacy variable, was reduced by 62+/-7% from baseline in patients on pimecrolimus, compared to 21+/-14% in patients on vehicle (P=0.013). With pimecrolimus there was also a better control of pruritus (P=0.042) at week 4 whereas a better control of disease according to self-assessment could only be observed at weeks 2 (P=0.01) and week 3 (P=0.08).. Pimecrolimus cream 1% is effective in patients with asteatotic eczema.

Topics: Adult; Dermatologic Agents; Eczema; Female; Humans; Male; Middle Aged; Pharmaceutical Vehicles; Tacrolimus

Treatment with topical glucocorticoids in children with atopic eczema may be associated with systemic adverse effects, such as suppression of growth.. To asses if treatment with topical mometasone furoate 0.1% or topical tacrolimus 0.1% affects short-term growth in children with atopic eczema. Primary outcome measures were lower leg growth rates measured by knemometry.. Twenty 5- to 12-year-old prepubertal children with atopic eczema were included in a randomised, investigator-blind crossover study with five periods: two treatment periods, a run in, a wash out and a run out. All periods were of 2-week duration. The subjects applied mometasone furoate ointment 0.1% once daily during one treatment period and tacrolimus ointment 0.1% twice daily during the other treatment period.. As compared to run in mean lower leg growth rate during mometasone furoate and tacrolimus treatment was reduced by 0.09 and 0.06 mm/week, respectively, (F = 1.12, p = 0.35). Consistently, no statistically significant effects on urine levels of eosinophil protein X and crossed-linked N-telopeptides were detected.. Treatment with mometasone furoate or tacrolimus does not affect short-term growth in children with mild to moderate atopic eczema.

Topics: Administration, Topical; Anti-Allergic Agents; Bone Development; Child; Child, Preschool; Cross-Over Studies; Double-Blind Method; Drug Therapy, Combination; Eczema; Female; Growth Disorders; Humans; Immunosuppressive Agents; Leg; Male; Mometasone Furoate; Pregnadienediols; Severity of Illness Index; Tacrolimus; Time Factors; Treatment Outcome

Use of topical corticosteroids for the treatment of pityriasis alba is limited by their potential side-effects, such as skin atrophy especially with long-term use on the face. Pimecrolimus cream 1% is a topical calcineurin inhibitor that has anti-inflammatory properties, lacks the cutaneous side-effects associated with steroids, and provide a potential benefit for the treatment of pityriasis alba.. This 10-patient, prospective, single-arm, open-label, single-center, 12-week, investigator-initiated proof of concept study assessed the efficacy, safety, and patient acceptance of pimecrolimus cream 1% twice daily. In addition to pimecrolimus cream, patients used facial emollient containing SPF 15 sunscreen and mild soap-free cleanser. Efficacy assessments were Investigator Global Assessment (IGA) of disease severity and evaluation of uneven skin color, scaling, eczema, follicular keratosis, and pruritus. All efficacy assessments were reported on a 4-point scale (0 = none to 3 = severe).. Of the 10 patients enrolled (aged: 12-35 years), all had intensive sun-exposure, 90% had skin type IV-V, and 80% completed the 12-week treatment. At baseline, mean IGA was 1.20 (mild-moderate), uneven skin color was 2.3 (moderate-severe) and scaling was 1.2 (mild). IGA decreased to 0.25 by week 12, uneven skin color improved by week 3 with near complete resolution by week 12 (mean = 0.38) and scaling resolved at week 3. Pruritus, eczema, and follicular keratosis remained at low levels from baseline throughout the course of the study. Patients consistently reported satisfaction with the treatment ("satisfied" or "very satisfied"). No adverse events were reported.. Pimecrolimus cream 1% may represent an alternative for the treatment of pityriasis alba.

Topics: Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Child; Drug Administration Schedule; Eczema; Female; Humans; Hypopigmentation; Male; Pityriasis; Prospective Studies; Pruritus; Severity of Illness Index; Skin; Tacrolimus; Treatment Outcome

The atopy patch test (APT) is an in vivo model to study the induction of eczema by inhalant allergens in atopic dermatitis patients. We studied the effect of pretreatment with topical tacrolimus 0.1% on APT in nonlesional skin of patients with atopic dermatitis.. Nonlesional skin of the back of patients with atopic dermatitis (n = 8) was treated once daily for 3 weeks with tacrolimus 0.1% ointment. Cetomacrogol ointment (placebo) was used as a negative control and triamcinolone acetonide 0.1% ointment as positive control. Twenty-four hours after the last APT application, samples were taken from the three treated areas (t = 0 and 24 h) for immunohistochemical analysis.. Pretreatment with tacrolimus ointment did not suppress nonlesional skin infiltrate, in contrast to triamcinolone acetonide. Furthermore, tacrolimus did not inhibit the induction of the APT macroscopically (t = 24 h). An equal influx of T cells, eosinophils, dendritic cells, CD64+ and Fc epsilon RI-positive cells was present compared with placebo. Only CD36+ and CD68-positive cells were inhibited compared with placebo. All cell types were significantly inhibited in triamcinolone acetonide-treated sites compared with placebo.. Pretreatment with tacrolimus 0.1% ointment does not inhibit the APT reaction in patients with atopic dermatitis.

Topics: Adult; Allergens; Biopsy; Cetomacrogol; Dendritic Cells; Dermatitis, Atopic; Eczema; Eosinophils; Female; Humans; Immunosuppressive Agents; Male; Patch Tests; Predictive Value of Tests; Receptors, IgG; Surface-Active Agents; T-Lymphocytes; Tacrolimus; Time Factors; Triamcinolone Acetonide

It is well known that topical tacrolimus is safe and effective in the treatment of atopic dermatitis (AD) patients. Tacrolimus is primarily an immunosuppressive agent without any antistaphylococcal effects. Thus colonization of Staphylococcus aureus on the skin of patients treated with this agent might be increased. The purpose of this study was to determine the effect of tacrolimus on S. aureus colonization in patients with AD and to compare the results with clinical severity and skin barrier function. We enrolled 65 patients with moderate to severe AD. They were treated with 0.03% tacrolimus ointment twice daily for 4 weeks. Clinical severity was assessed by the eczema area and severity index (EASI). S. aureus colonization was measured by the tape method. Skin barrier function was checked by measuring transepidermal water loss (TEWL). Evaluations were performed at weeks 0 (baseline), 1, 2 and 4. The results were compared and statistical analysis was performed. S. aureus colonization was significantly decreased with tacrolimus treatment at week 1 compared with baseline. However, there were no differences among weeks 1, 2 and 4. EASI and TEWL showed a decreasing tendency in a time-dependent fashion. The correlations between data were variable.

Topics: Administration, Topical; Adolescent; Adult; Blood-Air Barrier; Child; Child, Preschool; Colony Count, Microbial; Dermatitis, Atopic; Eczema; Female; Humans; Immunosuppressive Agents; Male; Seasons; Skin; Staphylococcus; Tacrolimus; Water Loss, Insensible

In the published studies on the efficacy of the topical immunomodulator pimecrolimus, different eczema scores were used, and the impact on morphological key signs of eczema was not analysed.. To compare the influence of pimecrolimus cream 1% on different standard eczema scores in infants with atopic dermatitis and to analyse the impact of treatment on the individual morphological key signs of eczema.. Pimecrolimus cream 1% (n = 129) or double-blind vehicle control (n = 66) was administered for 4 weeks. The Eczema Area and Severity Index (EASI), Investigators' Global Assessment (IGA) and Scoring Atopic Dermatitis Index (SCORAD) were determined and were correlated with each other.. Following treatment with pimecrolimus, the EASI, IGA and SCORAD were significantly reduced on day 29 as compared with the vehicle group (p < 0.001, p < 0.001, p = 0.002, respectively). There was a close correlation between EASI, IGA and SCORAD. The single parameters of the EASI were already significantly decreased by day 4 in the pimecrolimus group as compared to vehicle (each p < 0.001).. Treatment with pimecrolimus 1% cream leads to a rapid improvement of all morphological signs of eczema. The close correlation of different scores was shown for the first time.

Topics: Administration, Topical; Biopsy, Needle; Dermatitis, Atopic; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Eczema; Female; Follow-Up Studies; Humans; Immunohistochemistry; Infant; Male; Ointments; Probability; Reference Values; Risk Assessment; Severity of Illness Index; Tacrolimus; Treatment Outcome

Hand and foot eczema is a chronic skin disorder. Although topical corticosteroids are often used to control the predominant symptoms of the disease, the chronicity of the condition increases the risk of long-term adverse effects. A safer alternative is needed.. To evaluate the safety and efficacy of tacrolimus ointment 0.1% in hand and/or foot eczema.. Twenty-five adults applied tacrolimus ointment 0.1% to affected areas three times daily for 8 weeks and were followed for 2 additional weeks.. Except for vesiculation, compared with baseline there were significant improvements in erythema, scaling, induration, fissuring, composite severity, and pruritus (p<0.007). Two weeks after discontinuing treatment, significant improvement in scaling and composite severity (p<0.03) persisted, whereas erythema, induration, vesiculation, fissuring, and pruritus had returned to pre-treatment levels.. Tacrolimus ointment 0.1% is a promising corticosteroid alternative for hand/foot eczema.

Topics: Administration, Topical; Adult; Eczema; Female; Foot Dermatoses; Hand Dermatoses; Humans; Immunosuppressive Agents; Male; Middle Aged; Pilot Projects; Statistics, Nonparametric; Tacrolimus; Treatment Outcome

The aim of this study was to evaluate the efficacy and safety of combining dupilumab with topical tacrolimus for the treatment of atopic dermatitis (AD) in children aged 6 to 12 years.. A total of 168 pediatric (aged 6 to 12 years) patients with severe AD admitted to our hospital between April 2022 and April 2023 were included in this retrospective study. These patients are grouped according to different medication methods, assigned them to receive either tacrolimus plus topical corticosteroids (control group) or dupilumab combined with tacrolimus and topical corticosteroids (study group), with 84 patients in each group. Clinical efficacy and adverse reactions were primary clinical endpoints.. The use of dupilumab significantly increased the total effective rate for the patients by 14.29%, from 77.38% (65/84) in the control group to 91.67% (77/84) in the study group. Following treatment, patients given dupilumab showed a more significantly decreased peripheral blood eosinophils (EOS) and immunoglobulin E (IgE) levels than those without dupilumab treatment. Patients administered with dupilumab exhibited markedly lower scores on the Patient-oriented Eczema Measure (POEM) at weeks 12 and 16 and lower Eczema Area and Severity Index (EASI) scores at weeks 8, 12, and 16 when compared to those patients who did not receive dupilumab therapy. At the 16-week, 37 patients in the study group obtained a score of 1/0 on the Verified Investigator's Global Assessment (v-IGA) scale, whereas the control group had 24 such cases, indicating a significantly higher response rate provided by the protocol incorporating dupilumab. After 16 weeks of treatment, both groups demonstrated a marked decrease in itch numeric rating scale (NRS) scores and Dermatology Life Quality Index (DLQI) scores, with lower scores observed in the study group than in the control group. The absence of a significant difference in the incidence of adverse reactions between the two groups suggested a high safety profile of dupilumab.. The combination of dupilumab with topical tacrolimus demonstrated favorable efficacy in the management of AD in children aged 6 to 12 years. This treatment protocol effectively alleviates symptoms, enhances the quality of life of patients, and shows no increased risk of adverse reactions.

Topics: Child; Dermatitis, Atopic; Double-Blind Method; Eczema; Glucocorticoids; Humans; Quality of Life; Retrospective Studies; Severity of Illness Index; Tacrolimus; Treatment Outcome

To evaluate the role of tacrolimus ointment in the management of patients on dupilumab therapy for severe atopic dermatitis, in a real-life setting.. Consecutive patients with severe AD treated with dupilumab were enrolled. Topical treatment was associated according to the clinical practice. Eczema Area and Severity Index (EASI), itching and sleep Numerical Rating Scale (NRS) and Dermatologic quality of Life (DLQI) were recorded at baseline and after 4, 16 and 52 weeks of treatment with dupilumab.. Overall, 342 patients were enrolled, and 307 were evaluable. Tacrolimus was used by 6.5% (n=20) of patients at baseline, 11%, 13.5%, and 11.3% after 1, 4 and 12 months, respectively; the mean time to introduce tacrolimus after initiation of dupilumab was 8.3 ± 0.3 months. Low EASI score (<7; mild disease) after 1 month of systemic therapy was more frequent in patients who applied tacrolimus at baseline than in patients who did not (72.2% vs. 55.8%, p=0.027). Female sex, low DLQI scores, low age at dupilumab initiation, and non-generalized AD were correlated with an increased probability to start tacrolimus at any time during the study.. Data suggested that early treatment of localized areas with tacrolimus improves systemic treatment efficacy.

Topics: Dermatitis, Atopic; Eczema; Female; Humans; Pruritus; Quality of Life; Severity of Illness Index; Tacrolimus; Treatment Outcome

Topics: Eczema; Humans; Immunosuppressive Agents; Keratosis; Pruritus; Tacrolimus

Topics: Blepharitis; Dermatitis, Atopic; Eczema; Eyelids; Humans; Immunosuppressive Agents; Tacrolimus; Treatment Outcome

To unearth the clinical efficacy of tacrolimus ointment + 3% boric acid lotion joint Chinese angelica decoction in chronic perianal eczema.. Patients with chronic perianal eczema admitted to hospital from June 2018 and June 2019 were retrospectively analyzed. Patients in the control group (. No significant differences were found in the baseline information between the observation group and control group before therapy. After therapy, pruritus ani score (. With respect to tacrolimus ointment + 3% boric acid lotion, patients with chronic perianal eczema displayed better clinical efficacy after jointly being treated by Chinese angelica decoction.

Topics: Adult; Angelica; Animals; Anus Diseases; Boric Acids; Case-Control Studies; Chronic Disease; Computational Biology; Drug Therapy, Combination; Drugs, Chinese Herbal; Eczema; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Ointments; Phytotherapy; Pruritus Ani; Retrospective Studies; Skin Cream; Tacrolimus; Treatment Outcome

Topics: Dermatitis, Atopic; Eczema; Humans; Pharmacies; Pharmacy; Tacrolimus

Atopic dermatitis (AD) is the most common inflammatory skin disease affecting people of all age groups worldwide. To our knowledge, there are currently no studies estimating the effectiveness of tacrolimus ointment and dupilumab as a combination therapy for AD. Thus, here we describe the effectiveness and safety of tacrolimus ointment in combination with dupilumab for facial rashes in patients with AD. Overall, we included 109 patients who newly received dupilumab from April 2018 to July 2020 in the Dermatology Department of Hyogo College of Medicine Hospital. Of them, 60 patients were treated with tacrolimus ointment. Specifically, of the 60 patients, 40 were treated with dupilumab in combination with tacrolimus ointment and topical steroids, whereas the remaining 20 were prescribed tacrolimus ointment alone and were further analyzed. The analysis showed that the combination does not cause serious side-effects at high frequency. The patients showed rapid improvement of facial dermatitis along with systemic dermatitis, and the rate of improvement of head/neck Eczema Area and Severity Index (EASI) score significantly correlated with the rate of improvement of overall EASI score. In addition, there was no complication of herpes simplex observed in these 20 patients. Thus, tacrolimus ointment combined with dupilumab is an effective and safe treatment option for facial AD.

Topics: Antibodies, Monoclonal, Humanized; Dermatitis, Atopic; Eczema; Humans; Immunosuppressive Agents; Ointments; Tacrolimus; Treatment Outcome

Topics: Dermatitis, Atopic; Eczema; Humans; Severity of Illness Index; Tacrolimus

Topics: Adult; Dermatitis, Allergic Contact; Dermatologic Agents; Dose-Response Relationship, Drug; Eczema; Female; Humans; Tacrolimus

Atopic dermatitis (AD) is a highly pruritic, chronic inflammatory skin disease. The diagnosis is made using evaluated clinical criteria. Disease activity and burden are best measured with a composite score, assessing both objective and subjective symptoms, such as SCORing Atopic Dermatitis (SCORAD). AD management must take into account clinical and pathogenic variabilities, the patient's age and also target flare prevention. Basic therapy includes hydrating and barrier-stabilizing topical treatment universally applied, as well as avoiding specific and unspecific provocation factors. Visible skin lesions are treated with anti-inflammatory topical agents such as corticosteroids and calcineurin inhibitors (tacrolimus and pimecrolimus), which are preferred in sensitive locations. Topical tacrolimus and some mid-potency corticosteroids are proven agents for proactive therapy, which is defined as the long-term intermittent anti-inflammatory therapy of frequently relapsing skin areas. Systemic anti-inflammatory or immunosuppressive treatment is a rapidly changing field requiring monitoring. Oral corticosteroids have a largely unfavourable benefit-risk ratio. The IL-4R-blocker dupilumab is a safe, effective and licensed, but expensive, treatment option with potential ocular side-effects. Other biologicals targeting key pathways in the atopic immune response, as well as different Janus kinase inhibitors, are among emerging treatment options. Dysbalanced microbial colonization and infection may induce disease exacerbation and can justify additional antimicrobial treatment. Systemic antihistamines (H1R-blockers) only have limited effects on AD-related itch and eczema lesions. Adjuvant therapy includes UV irradiation, preferably narrowband UVB or UVA1. Coal tar may be useful for atopic hand and foot eczema. Dietary recommendations should be patient-specific, and elimination diets should only be advised in case of proven food allergy. Allergen-specific immunotherapy to aeroallergens may be useful in selected cases. Psychosomatic counselling is recommended to address stress-induced exacerbations. Efficacy-proven 'Eczema school' educational programmes and therapeutic patient education are recommended for both children and adults.

Topics: Adult; Anti-Inflammatory Agents; Calcineurin Inhibitors; Child; Dermatitis, Atopic; Eczema; Humans; Pruritus; Tacrolimus

New-onset psoriasis in patients receiving tumor necrosis factor inhibitors is well recognized in children and adults. We describe three children who underwent cardiac transplantation and developed an analogous form of paradoxic eczema occurring 2-48 months after starting systemic tacrolimus, a drug widely used topically to treat eczema. Anecdotal reports and our experience suggest that tacrolimus taper with alternative systemic antirejection immunosuppressant may lead to skin clearance. Pending additional insight, treatment should include optimizing skin barrier function, minimizing microbial and allergic triggers, and coordinating care to choose the best-tolerated systemic immunosuppressant regimen at the lowest effective dose.

Topics: Child; Child, Preschool; Eczema; Glucocorticoids; Heart Transplantation; Humans; Immunosuppressive Agents; Infant; Male; Skin; Tacrolimus

Topics: Administration, Topical; Adult; Boron Compounds; Bridged Bicyclo Compounds, Heterocyclic; Child; Dermatitis, Atopic; Eczema; Humans; Tacrolimus

Transient erythema after alcohol consumption is a side effect of topical tacrolimus use. The clinical picture is characterised by itching, a burning sensation and erythema, often at the site where tacrolimus is applied. The erythema develops shortly after alcohol consumption and disappears after approximately 1 hour.. We are describing a patient who used a 0.1% tacrolimus ointment for periocular eczema and in whom transient erythema developed around the eyes after alcohol consumption.. The symptoms may be caused by the capsaicin-like effects of both tacrolimus and ethanol. Potential inhibition of aldehyde dehydrogenase by tacrolimus may also play a role. Prophylactic treatment with acetylsalicylic acid before alcohol consumption reduces the symptoms.

Topics: Administration, Topical; Alcohol Drinking; Eczema; Erythema; Humans; Immunosuppressive Agents; Ointments; Pruritus; Tacrolimus

Topics: Dermatitis, Atopic; Dermatologic Agents; Double-Blind Method; Eczema; Humans; Tacrolimus; Treatment Outcome

The limited efficacy of topical tacrolimus may result from insufficient frequency of application or amount applied in eczema patients.. To investigate the frequency of application and amount of use of topical tacrolimus in patients with various types of eczema.. The frequency of application and the applied amount of topical tacrolimus were assessed over two weeks.. A total of 200 eczema patients completed this study. The average number of applications per day was 1.75 ± 0.53, despite instructions to apply the topical tacrolimus twice daily. With respect to the frequency of application, 147 (73.5%) and 122 (61.0%) of patients followed the prescription in the first and second weeks, respectively. The average amount applied per 2% of total body surface area (TBSA) was 0.54 ± 0.52 g. Only 53 (26.5%) patients applied between 80 and 120% of expected amount of topical tacrolimus.. The frequency of application was self-reported, possibly resulting in limited accuracy.. Korean patients with eczema tend to apply topical tacrolimus less frequently and in inappropriate amounts. Clear instructions regarding both the frequency and amount of application are needed to improve the therapeutic outcome with treatment with topical tacrolimus.

Topics: Administration, Topical; Adolescent; Adult; Aged; Asian People; Body Surface Area; Child; Dose-Response Relationship, Drug; Drug Administration Schedule; Eczema; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Republic of Korea; Severity of Illness Index; Tacrolimus; Young Adult

In this paper, we aimed to explore the potential mechanism underlying atopic dermatitis (AD) and its association with asthma. The BALB/c mice were randomly assigned to three groups, including the vehicle control (VD) group, the AD group, and the treatment (TR) group. The AD mice model was successfully constructed in the AD and TR group. The dermatitis severity scores and skin lesions were significantly increased in AD mice after DNCB application. Airway responsiveness in the AD group was significantly higher than in the TR group. The number of inflammatory cells was increased in skin lesions and bronchoalveolar lavage fluid (BALF) of AD mice. The levels of IL-4, IL-5, IFN-γ, and OVA-IgE in BALF supernatants of mice in the AD group were higher than those in the VC group. All the changes in AD mice were decreased by tacrolimus. These results indicate that AD may be a significant risk factor for atopic asthma development.

Topics: Animals; Asthma; Bronchoalveolar Lavage Fluid; Dermatitis, Atopic; Dinitrochlorobenzene; Eczema; Mice; Mice, Inbred BALB C; Tacrolimus

Topics: Dermatitis, Atopic; Eczema; Humans; Tacrolimus

Cancer risk associated with topical calcineurin inhibitors (TCIs) remains unclear.. To evaluate the association between TCIs and cancer among patients with atopic and endogenous eczema.. Incident cancers were identified from the National Cancer Registry. Data were analyzed using the Cox proportional hazards model to estimate hazard ratios (HRs) and 95% confidence intervals.. 880 unique cases of cancer developed in 66 176 patients from 2004 to 2012. The adjusted HRs for overall malignancy were 0.82 (95%CI 0.44-1.39) for tacrolimus-exposed and 1.30 (95%CI 0.59-2.45) for pimecrolimus-exposed. The only significant cancer association observed was lymphoid leukemia among the tacrolimus-exposed: HR 7.58 (95%CI 1.64-25.8). All affected patients had young-onset B-cell leukemia. Subgroup analysis of pediatric patients (≤16 years) showed significant association between tacrolimus use and B-cell leukemia: HR 26.4 (95%CI 4.77-146).. In this first Asian study on the risk of TCIs and malignancies, we do not find an association between use of tacrolimus and pimecrolimus in atopic and endogenous eczema and the overall development of malignancies. However, the use of topical tacrolimus was found to be associated with the development of B-cell acute lymphoid leukemia in pediatric eczema patients; further studies are required to investigate if a true association indeed occurs.

Topics: Administration, Topical; Asian People; Calcineurin Inhibitors; Child; Cohort Studies; Eczema; Female; Humans; Immunosuppressive Agents; Male; Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Risk; Tacrolimus

A bath with scented soap prompted a flare of the boy's eczema. Days later, he was hospitalized with diffuse erosions covering 90% of his body. What was the cause?

Topics: Acyclovir; Anti-Bacterial Agents; Antiviral Agents; Child, Preschool; Eczema; Exanthema; Humans; Kaposi Varicelliform Eruption; Male; Mentha; Perfume; Simplexvirus; Soaps; Steroids; Tacrolimus; Tretoquinol

Topics: Administration, Topical; Dermatitis, Atopic; Eczema; Humans; Immunosuppressive Agents; Tacrolimus

To assess off-label use of the topical calcineurin inhibitors (TCIs), tacrolimus and pimecrolimus, in children during periods before and after regulatory action by the US Food and Drug Administration (FDA) in 2005.. We identified new pediatric (age <20 years) users of topical tacrolimus or pimecrolimus in US Medicaid from 2001 to 2009, and examined the annual rate of drug use (pre- and postregulatory action) by age. We assessed medical claims for diagnoses consistent with an indication for a TCI, and assessed prescriptions for evidence of first-line atopic dermatitis therapy use before TCI initiation.. There were 57,664 eligible pediatric tacrolimus users and 425,242 eligible pediatric pimecrolimus users at baseline. The rate of TCI use decreased substantially after FDA regulatory action. The proportion of new users younger than 2 years of age significantly decreased for both tacrolimus (36.7% to 22.5%, P < .001) and pimecrolimus (47.0% to 33.7%, P < .001) after regulatory actions. Previous use of topical corticosteroids increased by ≈ 7% for both TCIs from the pre- to postregulatory period. However, after regulatory actions, there was only a small increase in the proportion of tacrolimus or pimecrolimus users with an atopic dermatitis or eczema diagnosis before drug initiation, and high strength use of tacrolimus was unchanged.. The rate of TCI use in children younger than 2 years of age fell substantially after FDA regulatory action in 2005. Off-label use of TCI as first-line therapy changed little.

Topics: Administration, Topical; Adolescent; Calcineurin Inhibitors; Child; Child, Preschool; Cohort Studies; Dermatitis, Atopic; Dermatologic Agents; Eczema; Female; Humans; Infant; Male; Medicaid; Off-Label Use; Tacrolimus; United States; Young Adult

New cases have been reported in France and elsewhere. Epidemiological studies show an increased risk of lymphoma.

Topics: Administration, Cutaneous; Eczema; Humans; Immunosuppressive Agents; Neoplasms; Risk Assessment; Risk Factors; Tacrolimus

Topics: Adrenal Cortex Hormones; Anti-Inflammatory Agents, Non-Steroidal; Confidence Intervals; Data Collection; Eczema; Histamine Antagonists; Humans; Internet; Meta-Analysis as Topic; Review Literature as Topic; Tacrolimus; Treatment Outcome; Ultraviolet Therapy

Topics: Administration, Topical; Adrenal Cortex Hormones; Eczema; Humans; Immunosuppressive Agents; Tacrolimus

To examine the 10-year outcome of affected body surface area (BSA), respiratory symptoms, and serum IgE in adult AD patients 6 years after a 4-year intervention with topical tacrolimus.. Patients who 10 years ago participated in a 4-year, open tacrolimus study (n = 65) were contacted for assessment of affected BSA, bronchial hyper-reactivity (BHR), respiratory symptoms, skin prick tests and serum IgE.. Altogether, 50 (77%) patients attended the follow-up visit. The median affected BSA decreased from 19% to 1.6% during the 10-year follow-up (p < 0.0001). Patients with active asthma and rhinitis symptoms at baseline reported a significant decrease at the follow-up (p = 0.02 andp = 0.01). In patients with BHR at baseline, the provocative dose of inhaled histamine producing a 15% decrease in FEV(1) increased. Responders (>or= 60% improvement of affected BSA) to tacrolimus treatment at the 1-year visit had a significantly smaller affected BSA at the 4- and 10-year visits than non-responders (< 60% improvement). Responders also showed a significant decrease in serum IgE at the follow-up visit compared to baseline (p = 0.002).. The long-term, effective treatment of patients with AD may have a beneficial effect on affected BSA, respiratory symptoms, and serum IgE.

Topics: Administration, Topical; Adolescent; Adult; Asthma; Body Surface Area; Bronchial Hyperreactivity; Cohort Studies; Dermatitis, Atopic; Dose-Response Relationship, Drug; Drug Administration Schedule; Eczema; Female; Follow-Up Studies; Humans; Immunoglobulin E; Male; Middle Aged; Respiratory Function Tests; Retrospective Studies; Risk Assessment; Skin Tests; Tacrolimus; Time Factors; Young Adult

Although clinical trials for new drugs are often limited in children because of safety concerns or restrictions, new therapies or novel strategies with old drugs have recently expanded dermatologic armamentarium for pediatric patients. Oral propranolol is currently the first choice in the treatment of alarming infantile hemangiomas. In atopic dermatitis, proactive strategy with topical calcineurin inhibitors can safely prevent disease exacerbation. Tacrolimus, in particular, is also useful for the treatment of vitiligo occurring in sensitive areas such as the eyelids. Among biologic drugs, use of etanercept is safe and efficient in children and adolescents with moderate-to-severe plaque psoriasis. Engineered tissues with special antimicrobial properties (silver-coated fabrics or engineered silk) are now used to treat eczema and fungal diseases in children. In athlete's foot, the use of 5-finger socks can also be helpful.

Topics: Adolescent; Adrenal Cortex Hormones; Alopecia Areata; Autoimmune Diseases; Child; Child, Preschool; Dermatitis, Atopic; Eczema; Female; Hemangioma; Humans; Immunosuppressive Agents; Male; Propranolol; Psoriasis; Randomized Controlled Trials as Topic; Skin Diseases; Tacrolimus; Therapies, Investigational; Vitiligo

Topics: Child; Dermatitis, Allergic Contact; Dermatologic Agents; Eczema; Female; Humans; Ointments; Patch Tests; Tacrolimus

Perianal eczema is an inflammatory skin disease with a high prevalence in most industrialized countries. As general practitioners and dermatologists frequently see patients with perianal eczema the need for efficient, fast and safe therapies is high. Topical calcineurin inhibitors such as tacrolimus (FK506) ameliorate cutaneous inflammation and associated pruritus in an array of inflammatory dermatoses.. To investigate the effect of topical tacrolimus in perianal eczema.. Twenty-four patients with perianal eczema were treated with tacrolimus 0.1% ointment twice daily on the affected skin area for 2 weeks.. All returning patients showed clinical improvement as assessed by macroscopic appearance and clinical score (modified SCORAD index).. In this short-term trial we demonstrate that topical tacrolimus 0.1% is safe, efficient and well tolerated in patients with perianal eczema irrespective of the underlying cause.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Anus Diseases; Eczema; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Patient Satisfaction; Tacrolimus; Treatment Outcome

The Food and Drug Administration has issued a public health advisory regarding cancer risk from topical calcineurin inhibitors.. To compare the rates of cancer among patients with common dermatologic conditions who were exposed or not exposed to topical calcineurin inhibitors.. A retrospective cohort observational study used data from an integrated healthcare delivery system on 953,064 subjects with diagnoses of atopic dermatitis or eczema between 2001 and December 2004. The main endpoint was initial cancer diagnosis. Chart review was performed to confirm cancer diagnosis in the subjects exposed to topical calcineurin inhibitors when any particular cancer rate was at least 3 times higher than that in unexposed subjects. Data were analyzed using the Cox proportional hazards model.. Age- and sex-adjusted hazard ratios for all cancers were 0.93 (95% CI 0.81 to 1.07; p = 0.306) for tacrolimus-exposed versus -unexposed subjects and 1.15 (95% CI 0.99 to 1.31; p = 0.054) for pimecrolimus-exposed versus -unexposed subjects. T-cell lymphoma was the only cancer associated with a significantly increased risk among subjects exposed to tacrolimus (HR = 5.04, 95% CI 2.39 to 10.63; p < 0.001) or pimecrolimus (HR = 3.76, 95% CI 1.71 to 8.28; p = 0.010). Subsequent chart review of subjects in the exposed group with T-cell lymphoma found that 4 of 16 had skin lesions that were suspected to be the early lesions of T-cell lymphoma prior to exposure to tacrolimus or pimecrolimus. After these 4 cases were excluded, the age and sex hazard ratio for T-cell lymphoma was 5.44 (95% CI 2.51 to 11.79; p < 0.001) for tacrolimus and 2.32 (95% CI 0.89 to 6.07; p = 0.086) for pimecrolimus. There was no statistically significantly increased risk for other subgroups of cancer, including melanoma.. Exposure to topical tacrolimus or pimecrolimus was not associated with an increase in the overall cancer rate. Use of topical tacrolimus may be associated with an increased risk of T-cell lymphoma.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Calcineurin Inhibitors; Child; Child, Preschool; Cohort Studies; Dermatitis, Atopic; Eczema; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Infant; Lymphoma, T-Cell; Male; Middle Aged; Neoplasms; Proportional Hazards Models; Retrospective Studies; Risk; Tacrolimus; Young Adult

We report a case of staphylococcal impetigo in a girl treated with tacrolimus ointment (Protopic) for atopic dermatitis.. A 15 year-old girl was receiving treatment with tacrolimus 0.03% (Protopic) for an episode of atopic dermatitis. On reduction of applications of tacrolimus, a vesicular-pustular rash appeared and was treated with pristinamycin and valaciclovir. At the end of antibiotic and antiviral therapy, the vesicular-pustular rash recurred while the goal was receiving treatment once more with tacrolimus ointment 0.1%. The bacteriological and virological skin samples revealed B-haemolytic streptococcus group A. The negative results for cutaneous virological samples ruled out Kaposi-Juliusberg syndrome and a diagnosis of staphylococcal impetigo was made. The intrinsic imputability of tacrolimus was I3 (C3 S2).. The most obvious specific feature of this impetigo was its limitation to areas of eczema treated by application of tacrolimus. In prospective studies in large patient cohorts, tacrolimus ointment has been associated with two types of adverse effect: local irritations and skin infections chiefly caused by Staphylococcus aureus. To date, there have been no reports in the literature of impetigo due to haemolytic B streptococcus following application of tacrolimus. Because of its immunodepressant effect, tacrolimus ointment may result in increased incidence of skin infections even though a number of studies have shown a reduction in such infections.

Topics: Administration, Oral; Adolescent; Eczema; Female; Humans; Immunosuppressive Agents; Impetigo; Staphylococcal Infections; Tacrolimus; Treatment Outcome

The Wiskott-Aldrich syndrome is a rare X-linked immunodeficiency characterized by microplatelet thrombocytopenia and eczema. Eczema may be severe and facilitate entry of microorganism into the host.. We report for the first time that eczema in infants with WAS can be effectively treated with topical ttacrolimus.

Topics: Administration, Cutaneous; Eczema; Humans; Immunosuppressive Agents; Infant; Male; Tacrolimus; Treatment Outcome; Wiskott-Aldrich Syndrome

Topics: Adult; Eczema; Humans; Immunosuppressive Agents; Male; Nail Diseases; Ointments; Tacrolimus

Pimecrolimus (SDZ ASM 981), an ascomycin derivative, as one of the new classes of immunomodulating macrolactams, is specifically effective in the treatment of inflammatory skin diseases. The interest in pimecrolimus is highly important for its significant anti-inflammatory activity, cell-selective inhibition of inflammatory cytokines, immunomodulatory capabilities, and low systemic immunosuppressive potential. The mechanism of action of pimecrolimus is the blockage of T cell activation, blocking signal transduction pathways in T cells, and inhibition of the synthesis of inflammatory cytokines, specifically Th1- and Th2-type cytokines. Several studies have evaluated the effectiveness of pimecrolimus as the treatment of choice for inflammatory skin diseases.

Topics: Chronic Disease; Dermatitis, Atopic; Eczema; Immunologic Factors; Immunosuppressive Agents; Inflammation; Psoriasis; Skin Diseases; Tacrolimus

Topics: Adult; Animals; Child; Child, Preschool; Dermatitis, Atopic; Dermatologic Agents; Eczema; Humans; Immunosuppressive Agents; Lymphoma; Skin Neoplasms; Tacrolimus

Topics: Animals; Child; Dermatitis, Atopic; Dermatologic Agents; Eczema; Haplorhini; Humans; Leukemia; Lymphoma; Mice; Skin Neoplasms; Tacrolimus

Dermatitis is a group of highly pruritic chronic inflammatory skin diseases which represents a major public-health problem worldwide. The prevalence of dermatitis has increased in recent years affecting up to 20% of the general population. Acute skin lesions are characterized by extensive degrees of intercellular edema of the epidermis (spongiosis) and a marked perivenular inflammatory cell infiltrate in the dermis. Keratinocytes within eczematous lesions exhibit a modified expression of proinflammatory cytokines, chemokines and cell-surface molecules. The pathophysiological puzzle of dermatitis is far from being elucidated completely, but skin infiltration of activated memory/effector T cells are thought to play the pivotal role in the pathogeneses. The aim of this study was the set-up of organotypic models mimicking the symptoms of eczematous dermatitis to provide a tool for therapeutic research in vitro. Therefore activated T cells (ATs) were integrated in organotypic skin and epidermis equivalents (SE, EE). These models enabled the reproduction of several clinical hallmarks of eczematous dermatitis: (1) T cells induce keratinocyte apoptosis, which leads to a reduced expression of the adhesion molecule E-cadherin (E-cad) and disruption of the epidermal barrier. (2) Expression of intercellular adhesion molecule-1 (ICAM-1) allows the attachment of leukocytes to epidermal cells. (3) Upregulation of neurotrophin-4 (NT-4) in the epidermis is thought to mediate pruritus in lesions by supporting nerve outgrowth. (4) Elevated levels of pro-inflammatory cytokines (IL-1alpha and IL-6) and chemokines (IL-8, IP-10, TARC, MCP-1, RANTES and eotaxin) amplify the inflammatory response and lead to an influx of secondary immunocells into the skin. The therapeutics dexamethasone and FK506 markedly reduce cytokines/chemokines production and epidermal damaging in these models. These data underline that activated memory/effector T cells induce eczematous changes in this HaCaT cell based organotypic skin equivalent. Furthermore it can be concluded that these models make it possible to investigate targets of therapeutics in skin.

Topics: Cytokines; Dexamethasone; Eczema; Electric Impedance; Humans; Immunologic Memory; Intercellular Adhesion Molecule-1; Keratinocytes; Leukocyte Common Antigens; Lymphocyte Activation; Nerve Growth Factors; Skin; T-Lymphocytes; Tacrolimus

Topics: Adolescent; Adrenal Cortex Hormones; Adult; Algorithms; Calcineurin Inhibitors; Child; Child, Preschool; Controlled Clinical Trials as Topic; Dermatitis, Atopic; Dermatologic Agents; Double-Blind Method; Eczema; Humans; Immunosuppressive Agents; Infant; Ointments; Practice Guidelines as Topic; Tacrolimus; Time Factors

Topics: Calcineurin Inhibitors; Eczema; Foot Dermatoses; Hand Dermatoses; Humans; Immunosuppressive Agents; Tacrolimus

Topics: Angina, Unstable; Angioplasty, Balloon, Coronary; Anticoagulants; Botulinum Toxins; Botulinum Toxins, Type A; Dermatitis, Atopic; Dermatologic Agents; Eczema; Hirudin Therapy; Hirudins; Humans; Immunosuppressive Agents; Neuromuscular Agents; Peptide Fragments; Recombinant Proteins; Tacrolimus; Torticollis; United States; United States Food and Drug Administration

Topics: Eczema; Humans; Immunosuppressive Agents; Tacrolimus