Hydroxychloroquine-induced generalized myopathy in a patient with lupus tumidus: a case report.

A subtype of cutaneous lupus erythematosus known as lupus erythematosus tumidus (LET) is characterized by sun-exposed areas that typically display urticaria-like papules and plaques. For LET, systemic therapy with antimalarials - particularly hydroxychloroquine (HCQ) - is the first line of treatment. Even though the safety profile of these medications appears to be high, there have been very few reports of side effects in the literature, including hemolytic anemia, retinal toxicity, maculopapular rash, gastrointestinal disturbance, and blue-gray discoloration of the skin or mucous membranes. Here, we report a unique instance of a 46-year-old LET smoker who, following HCQ treatment, developed a generalized myopathy.

308 nm excimer laser and tacrolimus ointment in the treatment of facial vitiligo: a systematic review and meta-analysis.

This study aimed to investigate the effects and safety of 308 nm excimer laser (308 nm EL) and tacrolimus ointment (TO) in the treatment of facial vitiligo (FV). We searched Cochrane Library, PUBMED, EMBASE, CNKI, and WANGFANG from inception to June 1, 2023. Outcomes included overall response rate (ORR), total adverse reaction rate (TARR), recurrence rate at 3-month (RR-3) and recurrence rate at 6-month (RR-6). The outcome data were presented as odds ratios (OR) with 95% confidence intervals (CI). The risk of bias was assessed by Cochrane risk-of-bias tool and data analysis was performed by RevMan 5.4 software. This study included a total of 19 trials involving 2085 patients. When comparing 308 nm EL monotherapy with 308 nm EL plus TO, significant differences in the ORR (OR = 4.29, 95% CI [2.97, 6.19], I2 = 0%, P < 0.001), RR-3 (OR = 0.18, 95% CI [0.05, 0.69], I2 = 0%, P = 0.01), and RR-6 (OR = 0.38, 95% CI [0.14, 1.03], I2 = 39%, P = 0.06) were found between the two managements. When comparing TO monotherapy with TO plus 308 nm EL, its results showed significant differences in the ORR (OR = 4.21, 95% CI [2.90, 6.11], I2 = 0%, P < 0.001), TARR (OR = 0.42, 95% CI [0.22, 0.81], I2 = 4%, P = 0.009), and RR-3 (OR = 0.32, 95% CI [0.01, 8.03], P = 0.49) between the two modalities. The results of this study suggest that the combination of 308 nm EL and TO is more effective than either treatment alone for the treatment of FV.

Comparing the effects of proactive treatment with tacrolimus ointment and mometasone furoate on the epidermal barrier structure and ceramide levels of patients with atopic dermatitis.

BACKGROUND: The epidermal skin barrier and lipids that are integral to its structure are impaired in atopic dermatitis (AD). Current treatment guidelines include proactive therapy. OBJECTIVE: This study assessed the effect of 12 weeks of proactive treatment with tacrolimus ointment 0.1% (TAC) compared with mometasone furoate cream (MF) on specific skin barrier lipids in patients with AD who previously received 10 days of reactive treatment with either agent. METHODS: This was an open-label, non-interventional study. In the reactive phase, forearm lesions in 20 patients were treated with either TAC or MF twice daily for 10 days. In the subsequent proactive phase, patients applied TAC or MF twice weekly for 12 weeks (n = 16 patients). RESULTS: Over the 12-week proactive treatment period, the mean local SCORAD significantly decreased in the TAC and MF treatment group. Levels of total and individual ceramides increased in both groups. Normalized intercellular lipid lamellae values were significantly higher with proactive TAC treatment than MF and undistinguishable from healthy skin. CONCLUSION: The results show that proactive treatment with TAC is superior in restoring the skin barrier.

Meta-analysis of efficacy and safety of fire needling combined with tacrolimus ointment in treatment of vitiligo / 国际中医中药杂志

Objective:To systematically evaluate the efficacy and safety of filiform fire needle combined with tacrolimus ointment in the treatment of vitiligo.Methods:The RCTs of combination of filiform fire needle and tacrolimus ointment on the treatment of vitiligo were searched in the Chinese Biomedical Literature Database (CBM), China Knowledge Network Full-text Database (CNKI), Wanfang Full-text Database, VIP and PubMed databases. The studies were selected with the inclusion and exclusion criteria, then data extracted, and the quality of the included studies was evaluated according to Cochrane System Evaluation Manual. Meta-analysis was performed using RevMen 5.3 software.Results:Four studies involving 218 patients were included. After analysis, it was found that the effective rate [ OR=4.42, 95% CI (1.39-14.03), P<0.05)] and the apparent efficiency [ OR=2.89, 95% CI (1.40-5.95), P=0.004] of filiform fire needle combined with tacrolimus ointment were significantly better than that of tacrolimus ointment alone. Adverse reactions werelocal slight redness, pain and itching. None of adverse reactionswas reported. Recurrence occurred in the follow-up of were reported in two studies, which found that the recurrence rate [ OR=0.17, 95% CI (0.04-0.77), P<0.05] in the combined treatment group was significantly lower than that in the control group. Conclusions:The clinical efficacy of filiform fire needle combined with tacrolimus ointment in the treatment of vitiligo is better than that of tacrolimus ointment alone, and the recurrence rate can be reduced without any adverse reactions. However, in view of the limited number, average quality and bias of the included studies, it is suggested to carry out more multi-center, large sample and high quality randomized controlled trials for further verification.

Recurrent Plaque Morphea Successfully Treated with PDO Mono Threads and Topical Tacrolimus Ointment.

The term plaque morphea describes a variant of morphea (localized scleroderma) in which oval or round circumscribed areas of induration, pigmentary changes, and violaceous or erythematous halo (i.e., lilac ring) are found in the dermis and occasionally to the superficial panniculus. We report a case of 28-year-old male patient with recurrent plaque morphea who was treated with polydioxanone (PDO) mono threads and topical tacrolimus ointment. After the introduction of PDO mono threads, the patient was prescribed topical tacrolimus ointment for six months. After that six-month period, the lesions were softer to palpation and lighter in color. This was observed as a positive therapeutic response. Notably, no future recurrence was seen at one-year follow up.

Comparison of anti-atopic dermatitis activities between DHMEQ and tacrolimus ointments in mouse model without stratum corneum.

This study is aimed to further investigate the anti-atopic dermatitis (AD) activities of dehydroxymethylepoxyquinomicin (DHMEQ) ointment and compare its effect with that of tacrolimus ointment based on the previous study that DHMEQ improves AD-like lesions. AD were induced by 2,4-dinitroclilorobenzene/oxazolone (DNCB/OX) repeatedly on the ears of BABL/C mice while medical tape was additionally used to disrupt stratum corneum in order to exacerbate the lesions. The mice were randomly divided into groups, which are normal, vehicle, DHMEQ (0.1%) and tacrolimus (0.1%). Those in the last two groups were externally applied with DHMEQ ointment and tacrolimus ointment, respectively. The results showed that both of them significantly improved dermatitis symptoms of DNCB/OX-induced AD-like lesions, such as redness, itching, weeping, scaling and thickening of the skin, while reducing epidermis thickness, dermis thickness and the number of mast cells as well, which were examined histopathologically. In contrast with DHMEQ, tacrolimus led to a significant decrease in body weight after long-term application. Both DHMEQ and tacrolimus suppress DNCB-induced increase of serum total IgE and attenuate expression of inflammatory factors IL-4, IL-6, IL-13, IL-1ß and interferon (IFN)-γ in the disrupted ear tissues. On the other hand, the mice applied with tacrolimus became obviously irritable, jumping up and down, and inflammatory exudation on the lesioned-skin surface of the mice was remarkably observed. Contrary to the side effects made by tacrolimus, DHMEQ didn't cause any adverse stimulus response. As a conclusion, DHMEQ is safer, milder and more suitable for long-term use than tacrolimus for the treatment of AD-like lesions.

Dermatologic tacrolimus ointment on the eyelids for steroid-refractory vernal keratoconjunctivitis.

PURPOSE: The study aims to evaluate the therapeutic effects of dermatologic tacrolimus ointment on eyelids to treat refractory vernal keratoconjunctivitis (VKC). METHOD: This institutional study examined the effects of steroid treatment for 10 patients diagnosed with severe VKC refractory to steroid treatment. Patients received 0.1% dermatologic topical tacrolimus treatment on their eyelids once or twice daily for concomitant atopic dermatitis. The therapeutic outcomes were evaluated according to change in severity of clinical findings recorded with serial external ocular photography and change in requirement for steroid treatment. RESULTS: Clinical signs and symptoms improved substantially after tacrolimus treatment. Significant reduction in size of papillae, decrease of discharge, improvement in hyperemia, and shield ulcer healing with re-epithelization were observed in all patients. Six out of 10 (60%) patients did not receive steroid treatment. Long-term maintenance of tacrolimus was required to prevent episodic exacerbation. Patients' only treatment-related complaints were of mild burning sensations during medication application to eyelids, and this sensation disappeared a few days after treatment. CONCLUSIONS: Application of 0.1% dermatologic tacrolimus ointment to eyelids is effective and safe in the treatment of refractory VKC in patients with concomitant atopic dermatitis. This treatment may serve as a substitute for or decrease the requirement of steroid treatment.

Quality Testing of Tacrolimus Ointment Mixed with Various Type of Ointments or Creams.

Tacrolimus ointment is used worldwide to treat atopic dermatitis. Although tacrolimus ointment is not suitable for clinical admixtures, it is often mixed with various ointments or creams, such as corticosteroids, antibacterial agents, and moisturizing agents. There is only one report of quality testing of admixtures of tacrolimus ointment with adaparene gel (Differin® Gel). In this study, we used HPLC to evaluate the pharmaceutical stability of tacrolimus mixed with eight different dermatologic ointments or creams. No decrease in the tacrolimus content was observed in any of the mixtures after 4 weeks of storage at room temperature, indicating that tacrolimus admixtures are stable.

Utility of dermoscopy for evaluating the therapeutic efficacy of tacrolimus ointment plus 308-nm excimer laser combination therapy in localized vitiligo patients.

The aim of the present study was to assess the function of dermoscopy in evaluating the therapeutic efficacy of tacrolimus ointment plus 308-nm excimer laser combination therapy in patients with localized vitiligo. A total of 147 patients with localized vitiligo (progressive disease, n=92; stable period, n=55) were enrolled and received combination therapy for 12 weeks. The condition of the skin lesions was monitored by dermoscopy and visual observation. At the initial visit, skin lesions were observed in 61 progressive and 19 stable patients. Residual perifollicular pigmentation was more abundant in progressive-stage patients than in stable-stage patients, whereas the presence of perilesional hyperpigmentation was obviously lower in patients with progressive vitiligo. After 12 weeks of combination therapy, marked differences in residual perifollicular pigmentation were identified between the progressive- and stable-stage patients. Dermoscopy and visual observation indicated that the 12-week treatment efficacy in patients with progressive disease was significantly higher than in those with stable disease and that assessment by dermoscopy was superior to visual observation at 8 or 12 weeks of treatment. Binary logistic regression analysis revealed that the disease stage, vitiliginous areas and disease course were risk factors associated with the treatment efficacy of the combination therapy. In conclusion, dermoscopy may be used as an effective means of vitiligo therapy assessment to provide an accurate and scientific evaluation of treatment efficacy for localized vitiligo patients.

Near-infrared light combined with tacrolimus ointment for the treatment of facial glucocorticoid-dependent dermatitis: a randomized controlled trial / 中华皮肤科杂志

Objective To evaluate the efficacy and safety of near-infrared light combined with tacrolimus 0.1％ ointment in the treatment of facial glucocorticoid-dependent dermatitis.Methods A total of 68 patients with facial glucocorticoid-dependent dermatitis were enrolled from Department of Dermatology of Yantai Yuhuangding Hospital between December 2014 and December 2015,and randomly and equally divided into treatment group and combination group by a random number table.The treatment group was treated topically with tacrolimus ointment twice a day for 4 weeks.Besides the treatment with tacrolimus ointment,the combination group was irradiated with near-infrared light once a week for 4 sessions.After 4-week treatment,improvement in clinical manifestations such as itching and burning sensation was evaluated,so was the therapeutic effect.Results The combination group showed significantly higher response rate (85.3％ [29/34]) compared with the treatment group (61.8％ [21/34],x2 =4.84,P ＜ 0.05).Additionally,response rates for itching and burning sensation,erythema,scales and papules were all significantly higher in the combination group than in the treatment group (x2 =4.84,6.35,8.42 and 5.52,respectively,all P ＜ 0.05).Conclusion Near-infrared light combined with tacrolimus ointment is effective and safe for the treatment of facial glucocorticoid-dependent dermatitis.

Combination of non-ablative fractional photothermolysis and 0.1% tacrolimus ointment is efficacious for treating idiopathic guttate hypomelanosis.

BACKGROUND: The efficacy of fractional photothermolysis and topical use of calcineurin inhibitors as treatments of idiopathic guttate hypomelanosis (IGH) have been reported. Data on combination treatments are lacking. OBJECTIVES: To evaluate the efficacy and safety of 1550-nm ytterbium/erbium fiber laser combined with 0.1% tacrolimus ointment as a treatment of IGH. METHODS: In each patient with IGH, two lesions were assigned as a treatment group, whilst two lesions on another side were chosen as control. Four treatments by fractional 1550-nm ytterbium/erbium fiber laser were delivered every four weeks combined with a twice daily topical application of 0.1% tacrolimus ointment. Lesional skin color was measured by colorimeter. Digital and dermoscopic digital photographs were taken and evaluated by three dermatologists. RESULTS: A total of 120 lesions were treated. Combination treatment normalized the relative lightness index of IGH which reached statistical significant compared with the control at week 12, after three sessions of laser treatment (p = 0.026). Physicians' assessment score revealed that 91.67% of the lesions on treatment side showed an improvement. Swelling and redness were the most common side effects which spontaneously resolved. CONCLUSION: Fractional 1550-nm ytterbium/erbium fiber laser combined with topical 0.1% tacrolimus ointment was effective for IGH.

Study on Percutaneous Absorption in vitro of 0.03%Tacrolimus Ointment / 中国药房

OBJECTIVE:To study the percutaneous absorption of 0.03% Tacrolimus ointment,and to compare the difference of domestic test preparation and imported reference preparation. METHODS:Modified Franz diffusion cells were adopted in trans-dermal test in vitro;HPLC-MS method was used to determine permeation amount and rate in vitro,delay time of domestic test preparation and imported reference preparation 0.03%Tacrolimus ointment. RESULTS:24 h in vitro permeation amount of test and reference preparations were(3 907±1 191)and(3 896±1 064)ng/cm2;permeation rates were 186.7 and 182.9 ng/(cm2·h);de-lay time were 1.95 and 2.00 h,respectively(P>0.05). CONCLUSIONS:Test preparation shows good percutaneous property,and is similar to reference preparation in penetration absorbency through nude mice skin.

Maintenance Therapy of Facial Seborrheic Dermatitis with 0.1% Tacrolimus Ointment.

BACKGROUND: Topical calcineurin inhibitors (TCIs) have been successfully used to treat seborrheic dermatitis (SD) patients. Meanwhile, treatment of atopic dermatitis (AD) with low-dose, intermittent TCI has been proved to reduce disease flare-ups. This regimen is known as a maintenance treatment. OBJECTIVE: The aim of this trial was to investigate the efficacy and tolerability of a maintenance treatment with tacrolimus ointment in patients with facial SD. METHODS: During the initial stabilization period, patients with facial SD or AD applied 0.1% tacrolimus ointment twice daily for up to 4 weeks. Clinical measurements were evaluated on either in the whole face or on separate facial regions. When an investigator global assessment score 1 was achieved, the patient applied tacrolimus twice weekly for 20 weeks. We also compared our results with recent published data of placebo controlled study to allow an estimation of the placebo effect. RESULTS: The time to the first relapse during phase II was similar in both groups otherwise significantly longer than the placebo group. The recurrence-free curves of two groups were not significantly different from each other; otherwise the curve of the placebo group was significantly different. There were no significant differences between the 2 groups in the number of DEs, and treatment days for disease exacerbations (DEs). The adverse event profile was also similar between the 2 groups. During the 20 weeks of treatment, the study population tolerated tacrolimus ointment well. CONCLUSION: The results of this study suggest that maintenance treatment with tacrolimus may be effective in preventing the occurrence of facial SD exacerbations.

Olopatadine hydrochloride suppresses hot flashes induced by topical treatment with tacrolimus ointment in rats.

Tacrolimus ointment is prescribed for patients with atopic dermatitis, although it is known to cause transient burning sensations and hot flashes in the applied skin. The aim of this study was to evaluate the effects of olopatadine hydrochloride (olopatadine), an antiallergic agent with a histamine H1 receptor (H1R) antagonistic activity, on the incidence of hot flashes induced by topical treatment with tacrolimus ointment in rats. Consequently, the skin temperature was increased by the topical application of tacrolimus ointment in rats, and the rise in skin temperature was inhibited by pretreatment with olopatadine in a dose-dependent manner. Inhibitory effect of olopatadine on tacrolimus-induced skin temperature elevation was significantly more potent than that of cetirizine hydrochloride, other antiallergic agent with H1R antagonistic activity, at doses in which both agents exhibit comparable H1R antagonistic activity in rats. These results suggest that H1R antagonistic activity-independent mechanism contribute to the inhibitory effect of olopatadine on tacrolimus-induced skin temperature elevation. Olopatadine also significantly inhibited increases in vascular permeability and nerve growth factor production in the skin induced by topical tacrolimus treatment. Thus, the onset of hot flashes in rats is quantitatively determined by measuring the skin temperature and olopatadine attenuates hot flashes induced by topical tacrolimus ointment in rats, suggesting that the combination application with olopatadine and tacrolimus ointment is useful for improving medication adherence with tacrolimus ointment treatment in patients with atopic dermatitis.

Tacrolimus 0.03% ointment in labial discoid lupus erythematosus: A randomized, controlled clinical trial.

In this randomized, controlled clinical trial to compare efficacy and safety, 41 patients with labial discoid lupus erythematosus (DLE) were randomized to 2 groups, either receiving tacrolimus 0.03% ointment (n = 22) or triamcinolone acetonide 0.1% cream (n = 19). Each patient was treated with 3, 2, and 1 daily doses in the first, second, and third weeks, respectively, for 1 course. After the 3 week treatment, patients with complete disappearance of erosion were followed up for 3 months. After the 3 week application, 20 participants in the tacrolimus group and 19 in the triamcinolone acetonide group completed the study. The rates of complete response were 70% and 89.5% in tacrolimus-treated and triamcinolone acetonide-treated patients, respectively, with no significant difference (P = .235). Reduction in erosion and erythema showed no significant difference between groups (P > .05). Final reduction in reticulation areas and numeric rating scale scores were significantly greater in the tacrolimus group than in the triamcinolone acetonide group (P = .013; P = .048, respectively). Only 1 patient receiving tacrolimus presented with slight discomfort. There was no significant difference in 3 month recurrence rate between the groups (P > .05). Topical tacrolimus is considered as effective as triamcinolone acetonide for the management of labial DLE.

A clinical observation of 107 cases of collagen dressing in treatment of facial hormone dependent dermatitis / 中国生化药物杂志

Objective To investigate clinical effect of collagen dressing in treatment of facial hormone dependent dermatitis.Methods 107 patients were divided randomly into treatment group and control group.53 cases of control group were given citrate desloratadine,ompound glycyrrhizin tablets, 0.3% tacrolimus ointment, cod liver oil ointment for 4 weeks.54 cases of treatment group were given collagen dressing 25 minutesper night, based on control group.After 4 weeks of drug treatment,treatment group continued to be given collagen dressing once every other night, control group were given cod liver oil ointment twice a day, morning and night.Both groups continued to observe for 12 weeks, at the same time, 0.3% tacrolimus ointment was given once every other day.Compared effect of two groups in the short-term and long-term.Results There were no significant differences in symptom scores between the two groups pre-treatment; compared with pre-treatment,the symptom scores were decreased(P<0.05).Compared with control group, the symptoms of treatment group were lower than that of treatment group(P<0.05).Compared with control group, the clinical total effective rate was higher than treatment group ( P<0.05 ) .Conclusion The collagen dressing can improve the facial treatment of hormone-dependent dermatitis.

Maintenance Therapy of Facial Seborrheic Dermatitis with 0.1% Tacrolimus Ointment

BACKGROUND: Topical calcineurin inhibitors (TCIs) have been successfully used to treat seborrheic dermatitis (SD) patients. Meanwhile, treatment of atopic dermatitis (AD) with low-dose, intermittent TCI has been proved to reduce disease flare-ups. This regimen is known as a maintenance treatment. OBJECTIVE: The aim of this trial was to investigate the efficacy and tolerability of a maintenance treatment with tacrolimus ointment in patients with facial SD. METHODS: During the initial stabilization period, patients with facial SD or AD applied 0.1% tacrolimus ointment twice daily for up to 4 weeks. Clinical measurements were evaluated on either in the whole face or on separate facial regions. When an investigator global assessment score 1 was achieved, the patient applied tacrolimus twice weekly for 20 weeks. We also compared our results with recent published data of placebo controlled study to allow an estimation of the placebo effect. RESULTS: The time to the first relapse during phase II was similar in both groups otherwise significantly longer than the placebo group. The recurrence-free curves of two groups were not significantly different from each other; otherwise the curve of the placebo group was significantly different. There were no significant differences between the 2 groups in the number of DEs, and treatment days for disease exacerbations (DEs). The adverse event profile was also similar between the 2 groups. During the 20 weeks of treatment, the study population tolerated tacrolimus ointment well. CONCLUSION: The results of this study suggest that maintenance treatment with tacrolimus may be effective in preventing the occurrence of facial SD exacerbations.

Maintenance Therapy of Facial Seborrheic Dermatitis with 0.1% Tacrolimus Ointment

BACKGROUND: Topical calcineurin inhibitors (TCIs) have been successfully used to treat seborrheic dermatitis (SD) patients. Meanwhile, treatment of atopic dermatitis (AD) with low-dose, intermittent TCI has been proved to reduce disease flare-ups. This regimen is known as a maintenance treatment. OBJECTIVE: The aim of this trial was to investigate the efficacy and tolerability of a maintenance treatment with tacrolimus ointment in patients with facial SD. METHODS: During the initial stabilization period, patients with facial SD or AD applied 0.1% tacrolimus ointment twice daily for up to 4 weeks. Clinical measurements were evaluated on either in the whole face or on separate facial regions. When an investigator global assessment score 1 was achieved, the patient applied tacrolimus twice weekly for 20 weeks. We also compared our results with recent published data of placebo controlled study to allow an estimation of the placebo effect. RESULTS: The time to the first relapse during phase II was similar in both groups otherwise significantly longer than the placebo group. The recurrence-free curves of two groups were not significantly different from each other; otherwise the curve of the placebo group was significantly different. There were no significant differences between the 2 groups in the number of DEs, and treatment days for disease exacerbations (DEs). The adverse event profile was also similar between the 2 groups. During the 20 weeks of treatment, the study population tolerated tacrolimus ointment well. CONCLUSION: The results of this study suggest that maintenance treatment with tacrolimus may be effective in preventing the occurrence of facial SD exacerbations.

Comparison of release and penetration of tacrolimus ointment reference and trial formulation after dermal application to pigs by liquid chromatography-electrospray ionization tandem mass spectrometry.

To investigate the consistency and bioequivalence of tacrolimus ointment reference and trial formulation, the tacrolimus concentrations in blood and skin were determined by HPLC-ESI-MS/MS following topical application of two kinds of ointment in porcine skin in a parallel, cross-over trial. The plasma protein of blood was precipitated by acetonitrile and the tacrolimus in skin was extracted by acetonitrile before HPLC-ESI-MS/MS analysis. The internal calibration method (diazepam was the internal standard) was used for quantification analysis (R(2) > 0.9999), with linear range from 0.05 to 5 ng/mL for blood samples and from 1 to 200 ng/mL for skin samples. The limits of detection for the porcine blood and skin were 0.005 and 0.5 ng/mL, respectively. The average recoveries for the porcine blood and skin spiked at three levels were 97.56-109.53 and 96.48-103.57%, respectively. The precision expressed in RSDs was from 3.43 to 10.83% for porcine blood and from 3.10 to 8.69% for porcine skin. For the same pig, the tacrolimus concentrations and variation with time of the two kinds of ointment in porcine skin were similar, although variation occurred with different individuals. These results showed that the release and penetration of tacrolimus from the reference and trial formulation are similar.

Clinical efficacy of 0.1％ tacrolimus ointment combined with paroxetine for the treatment of neurodermatitis / 中华皮肤科杂志

ObjectiveTo evaluate the clinical efficiency of 0.1％ tacrolimus ointment combined with paroxetine in patients with neurodermatitis associated with insomnia.MethodsTotally,74 patients suffering from neurodermatitis and insomnia were consecutively enrolled in this study,and randomly assigned into the combination group and control group according to their number(odd or even).Both groups were given topical 0.1％ tacrolimus ointment twice a day,and the combination group was additionally given oral paroxetine 10 mg once a day,for 8 weeks.The outcome parameters included main symptoms of neurodermatitis and Pittsburgh sleep quality index(PSQI) score.ResultsNo significant difference was observed in the cure rate (54.3％(19/35) vs.53.1％ (17/32),P＞ 0.05) or response rate (82.9％ (29/35) vs.81.3％ (26/32),P＞ 0.05),between the combination group and control group.PSQI score was significantly lower in the combination group than in the control group after 8 weeks of treatment(P ＜ 0.05).ConclusionsThe 0.1％ tacrolimus ointment can be used to treat neurodermatitis safely.Antianxiety treatment can reduce the recurrence of neurodermatitis associated with insomnia,and improve the quality of sleep in patients.