tacrolimus and Dermatitis--Seborrheic

Facial seborrheic dermatitis (SD), a chronic inflammatory skin condition, can impact quality of life, and relapses can be frequent. Three broad categories of agents are used to treat SD: antifungal agents, keratolytics, and corticosteroids. Topical therapies are the first line of defense in treating this condition.. Our objective was to critically review the published literature on topical treatments for facial SD.. We searched PubMed, Scopus, Clinicaltrials.gov, MEDLINE, Embase, and Cochrane library databases for original clinical studies evaluating topical treatments for SD. We then conducted both a critical analysis of the selected studies by grading the evidence and a qualitative comparison of results among and within studies.. A total of 32 studies were eligible for inclusion, encompassing 18 topical treatments for facial SD. Pimecrolimus, the focus of seven of the 32 eligible studies, was the most commonly studied topical treatment.. Promiseb

Topics: Administration, Cutaneous; Anti-Inflammatory Agents; Antifungal Agents; Calcineurin Inhibitors; Ciclopirox; Dermatitis, Seborrheic; Dermatologic Agents; Desonide; Facial Dermatoses; Humans; Ketoconazole; Malassezia; Mometasone Furoate; Plant Preparations; Practice Guidelines as Topic; Pyridones; Quality of Life; Randomized Controlled Trials as Topic; Tacrolimus; Treatment Outcome; Vitamins

Seborrheic dermatitis is a common, chronic, relapsing inflammatory skin disorder that manifests as erythema, scaling and pruritus in sebum gland-rich areas of the skin. The objective of this article is to evaluate the clinical efficacy of pimecrolimus 1% cream in the treatment of seborrheic dermatitis compared with corticosteroids, antimycotics, placebo or no intervention. Pimecrolimus 1% cream appears to be a well-tolerated and effective treatment for seborrheic dermatitis. It has comparable efficacy, in terms of decreasing severity of erythema, scaling and pruritus, to the standard treatments: topical corticosteroids and antimycotics. However, future studies with more standardized measures of treatment outcome are recommended. More studies may also be conducted to further evaluate pimecrolimus 1% cream as a long-term maintenance therapy for seborrheic dermatitis.

Topics: Administration, Cutaneous; Animals; Calcineurin Inhibitors; Chemistry, Pharmaceutical; Dermatitis, Seborrheic; Dermatologic Agents; Humans; Randomized Controlled Trials as Topic; Tacrolimus; Treatment Outcome

Seborrheic dermatitis (SD) is characterized by erythematous pruritic patches and plaques with greasy scale that occur in sebaceous areas. It is common, affecting up to 3% of the population. Past treatments have relied on a wide variety of anti-inflammatory and antifungal agents, but corticosteroids have limited use because of long-term adverse effects. Topical calcineurin inhibitors provide a safe alternative for the treatment of SD, as these drugs block the inflammatory cascade involved in the disease process and pose no risk of skin atrophy. Studies of topical pimecrolimus and tacrolimus in the treatment of SD have found that improvement occurred within 2 weeks, and if SD recurred after stopping treatment, it was significantly less severe. There have been no studies of the comparative efficacy of pimecrolimus versus tacrolimus for the treatment of SD. Common adverse effects of mild burning and irritation have been associated with the use of both of these agents. Safety profile studies are limited to studies of atopic dermatitis, which show no increase in infection rate, photocarcinogenicity, or signs of immunosuppression in patients using topical calcineurin inhibitors for long-term treatment. This article reviews the clinical trials of pimecrolimus and tacrolimus in the treatment of SD, focusing on efficacy and safety.

Topics: Administration, Cutaneous; Calcineurin Inhibitors; Dermatitis, Seborrheic; Dermatologic Agents; Humans; Patient Satisfaction; Secondary Prevention; Tacrolimus; Treatment Outcome

Within the last decade, healthcare providers have had a larger selection of effective novel topical immunomodulatory agents to treat many dermatologic conditions. Novel mechanisms of action of newer topical agents have facilitated differentiation from well-established topical agents such as corticosteroids and 5-fluorouracil. Further, because of a growing understanding of the immune mechanisms within the skin, the opportunity has arisen to use the body's immune system to effectively treat many dermatologic conditions, such as condyloma acuminata, actinic keratosis, basal cell carcinoma, and atopic dermatitis, while maintaining a favorable safety profile. Imiquimod 5% cream, an immune response modifier, is safe and effective in the treatment of condyloma acuminata, actinic keratosis, and primary superficial basal cell carcinoma (sBCC). Pimecrolimus cream 1% and tacrolimus ointment (0.1% and 0.03%) are safe and effective in the treatment of atopic dermatitis. This review highlights newer data on approved and investigational indications for these topical immunomodulatory agents.

Topics: Adjuvants, Immunologic; Administration, Topical; Aminoquinolines; Condylomata Acuminata; Dermatitis, Atopic; Dermatitis, Seborrheic; Humans; Hutchinson's Melanotic Freckle; Imiquimod; Keratosis; Melanoma; Membrane Glycoproteins; Receptors, Cell Surface; Skin Diseases; Skin Diseases, Viral; Skin Neoplasms; Tacrolimus; Toll-Like Receptors

Facial seborrhoeic dermatitis (FSD) is a chronic inflammatory skin disorder characterized by remission and exacerbation episodes. In most cases, FSD requires long-term treatment.. To compare the efficacy and safety of pimecrolimus and sertaconazole in patients with FSD.. In total, 60 patients with FSD were enrolled in this double-blind, active-controlled, randomized trial, and instructed to topically apply either pimecrolimus 1% cream (30 patients) or sertaconazole 2% cream (30 patients) twice daily for 4 weeks. Assessment of disease severity was performed using the Scoring Index (SI) at baseline, on Days 14 and 28, and at 4 weeks after treatment cessation. The levels of satisfaction from treatment and any adverse effects (AEs) were also assessed in both groups.. Although the severity of disease reduced upon treatment in both groups, application of pimecrolimus caused a significantly better improvement than sertaconazole on Days 14 and 28 (P < 0.01 and P < 0.001, respectively). The rate of relapse was significantly lower in the pimecrolimus compared with the sertaconazole group at 4 weeks after treatment cessation (P = 0.01). The highest level of satisfaction (46.7%) was observed on Day 28 in the pimecrolimus group. Both topical treatments had acceptable safety profiles; however, pimecrolimus 1% cream was significantly (P < 0.01) less irritating than sertaconazole 2% cream.. Pimecrolimus is associated with faster response and fewer AEs than sertaconazole in patients with FSD.

Topics: Dermatitis, Seborrheic; Dermatologic Agents; Double-Blind Method; Emollients; Humans; Imidazoles; Tacrolimus; Thiophenes; Treatment Outcome

No long-term maintenance therapy has been tested in patients with seborrheic dermatitis (SD).. We sought to compare the efficacy and tolerance of tacrolimus 0.1% ointment versus ciclopiroxolamine 1% cream as maintenance therapy for severe SD.. This double-blind randomized controlled study was conducted from 2014 to 2017 in 5 Dermatology Departments and 15 dermatology practices in France. Consecutive patients with severe and chronic facial SD were included. Patients were initially treated with desonide 0.05% cream twice daily for 7 days. Patients cleared after this open phase were randomized to receive tacrolimus 0.1% or ciclopiroxolamine 1% cream 2 times a week 24 weeks. The primary endpoint was disease-free-duration, defined as the time from randomization to first relapse.. One hundred fourteen patients were randomized (tacrolimus, n = 57; ciclopiroxolamine, n = 57). Twelve patients relapsed in the tacrolimus group after a median delay of 91.5 days (range 15-195 days) versus 23 patients in the ciclopiroxolamine group (median delay, 27 days [range 13-201 days]). Comparison of disease-free duration curves showed that patients in the tacrolimus group had a longer duration of complete remission than those in the ciclopiroxolamine group (P = .018), corresponding to a hazard ratio of relapse of 0.44 (95% confidence interval 0.22-0.89; P = .022).. The theoretical sample size was not reached.. Tacrolimus 0.1% is more effective than ciclopiroxolamine 1% as maintenance therapy for patients with facial SD.

Topics: Adult; Ciclopirox; Dermatitis, Seborrheic; Double-Blind Method; Drug Administration Schedule; Facial Dermatoses; Female; Humans; Maintenance Chemotherapy; Male; Middle Aged; Severity of Illness Index; Tacrolimus; Treatment Outcome

Pimecrolimus 1% cream has already been proved to be an effective and safe alternative to treat seborrheic dermatitis. However, the treatment periods were inconstant in previous studies.. To evaluate the comparative efficacy of pimecrolimus 1% cream with different regimens for the treatment of facial seborrheic dermatitis.. Thirty patients with facial seborrheic dermatitis were enrolled and randomly distributed to three groups. Patients of Group 1 were treated with topical pimecrolimus cream 1% twice daily for 2 weeks and then a moisturizer cream twice daily for 2 weeks. Patients of Group 2 were treated with pimecrolimus cream 1% twice daily for 2 weeks and then once daily for another 2 weeks. Patients of Group 3 had a consecutive course of pimecrolimus cream 1% twice daily for 4 weeks. Objective symptoms, subjective symptoms, and dermatology life quality index (DLQI) were measured at weeks 0, 2, 4, and 6.. At week 4, the clinical severity scores of all three regimens significantly decreased (P<.01). The improvement of total severity score in Group 3 was more remarkable than groups 1 and 2 (both P<.05). This effect was maintained until the end of the study in Group 3. Life quality of all three groups was significantly improved at week 4 (P<.001), while there was no statistical difference on the improvement of life quality among three groups.. We recommend pimecrolimus 1% cream could be applied twice a day for 4 weeks to treat seborrheic dermatitis.

Topics: Administration, Topical; Adult; Ambulatory Care; Dermatitis, Seborrheic; Dermatologic Agents; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Male; Middle Aged; Quality of Life; Risk Assessment; Severity of Illness Index; Skin Cream; Tacrolimus; Treatment Outcome

Seborrheic dermatitis (SD) is an inflammatory skin disorder affecting the scalp, face, and trunk. The treatment of SD is an important issue in dermatology. This study aimed at comparing the efficacy of sertaconazole 2 % cream versus pimecrolimus 1 % cream in the treatment of SD.. In this clinical trial study, 60 patients suffering from SD were studied. Thirty patients received local sertaconazole 2 % cream and in control group, 30 patients received pimecrolimus 1 % cream. Patients were recommended to use the cream twice a day for 4 weeks. At the beginning of referring and also 2 and 4 weeks after first visit, the patients were examined by a dermatologist to control improvement of clinical symptoms.. The mean age of members of the sertaconazole and pimecrolimus groups was 30.12 ± 12.56 and 34.67 ± 10.98 years, respectively. The highest level of satisfaction (90 %) was observed 28 days after sertaconazole application since it was 80 % in pimecrolimus group. The relationship between patients' satisfaction and receipt of sertaconazole cream (on the 28th day) was statistically significant (P = 0.006).. Sertaconazole 2 % cream may be an excellent alternative therapeutic modality for treating SD.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Child; Dermatitis, Seborrheic; Dermatologic Agents; Female; Humans; Imidazoles; Iran; Male; Middle Aged; Patient Satisfaction; Severity of Illness Index; Skin; Skin Cream; Tacrolimus; Thiophenes; Treatment Outcome; Young Adult

The treatment of seborrheic dermatitis (SD) includes topical antifungal agents to eradicate Malassezia spp. corticosteroids to treat the inflammatory component of the disease, and keratolytics to remove scale and crust. The aim of this study was to compare the efficiency of sertaconazole 2% cream and tacrolimus 0.03% cream in the treatment of seborrheic dermatitis. In this clinical trial study, sixty patients suffering from SD were studied. Thirty patients received local sertaconazole 2% cream with a recommendation to use the cream twice a day for 4 weeks. In the control group, thirty patients received tacrolimus 0.03% cream twice a day for four weeks. At the time of referral, and 2 and 4 weeks after first visit, the patients were examined by a dermatologist to check the improvement of clinical symptoms. The mean ages of the sertaconazole and tacrolimus groups were 30.98 +/- 12.24 and 34.67 +/- 10.82, respectively. The highest level of satisfaction (90%) was observed 28 days after sertaconazole use. Only 83.3% satisfaction was noted in the tacrolimus group. The relationship between patient satisfaction and sertaconazole 2% cream receive in 28th day was significant (P = 0.006). Sertaconazole 2% cream may be an excellent alternative therapeutic modality for treating seborrheic dermatitis.

Topics: Adolescent; Adult; Aged; Antifungal Agents; Child; Dermatitis, Seborrheic; Female; Humans; Imidazoles; Immunosuppressive Agents; Male; Middle Aged; Tacrolimus; Thiophenes; Young Adult

The effectiveness of intermittent topical tacrolimus to prevent relapse in patients with stabilized facial seborrhoeic dermatitis has not been evaluated. The aim of this study was to determine whether proactive use of 0.1% tacrolimus ointment can keep adult facial seborrhoeic dermatitis in remission. A total of 75 patients who had stabilized facial seborrhoeic dermatitis after 2 weeks' (open-label induction) treatment with 0.1% tacrolimus were randomized in a double-blind fashion to treatment with 0.1% tacrolimus once a week, twice a week, or vehicle twice a week, for 10 weeks (maintenance). Significant improvement in erythema, scaling and pruritus compared with baseline was maintained during the maintenance phase in both tacrolimus groups, but not in the vehicle group. The mean recurrence rate according to global assessment was significantly higher in the tacrolimus once-weekly group than in the twice-weekly group. In conclusion, twice-weekly treatment with 0.1% tacrolimus ointment had superior effects in keeping facial seborrhoeic dermatitis in remission.

Topics: Administration, Cutaneous; Adult; Aged; Chi-Square Distribution; Dermatitis, Seborrheic; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Facial Dermatoses; Female; Humans; Male; Middle Aged; Ointments; Remission Induction; Republic of Korea; Secondary Prevention; Tacrolimus; Time Factors; Treatment Outcome

Tacrolimus is a topical calcineurin inhibitor with immunomodulatory, anti-inflammatory, and fungicidal properties that may be beneficial in the treatment of facial seborrheic dermatitis.. We sought to compare the efficacy and safety of tacrolimus with standard corticosteroid treatment in adults with facial seborrheic dermatitis in a phase II, single-blind, randomized controlled trial.. Adult patients were enrolled in a 12-week study. Subjects were randomized to tacrolimus 0.1% ointment (n = 16) or hydrocortisone 1% ointment (n = 14) applied twice daily to symptomatic regions of the face. The primary efficacy measure was the severity of facial seborrhea at the end of treatment (day 84) as measured by the Seborrhea Area and Severity Index-Face. Secondary efficacy measures included physician and patient assessment of seborrhea, the frequency of medication application, and adverse events.. The severity of facial seborrhea was similarly improved in both treatment groups (P = .86). Tacrolimus 0.1% ointment was used on significantly fewer days than 1% hydrocortisone ointment (mean missed doses per patient at first visit: 15.6 vs 7.6, P < .05; at last visit: 13.5 vs 7.7, P = .08). The majority of doses were missed because of lack of symptoms. The adverse event profile for both agents was similar; however, there was a numerically higher incidence of adverse events in the hydrocortisone group.. This was a small, open-label study.. Tacrolimus 0.1% ointment required significantly fewer applications compared with hydrocortisone 1% ointment to achieve a comparable clinical response in adults with facial seborrheic dermatitis. Tacrolimus was generally well tolerated.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Dermatitis, Seborrheic; Facial Dermatoses; Female; Humans; Hydrocortisone; Immunosuppressive Agents; Male; Middle Aged; Ointments; Single-Blind Method; Tacrolimus; Young Adult

Treatment options for seborrheic dermatitis are numerous, including both topical and systemic agents (e.g. topical corticosteroids, oral antifungals, and psoralen plus UVA). However, long-term use of topical corticosteroids may lead to adverse effects. Pimecrolimus 1% cream is an effective and well tolerated treatment for seborrheic dermatitis.. To explore the efficacy of pimecrolimus 1% cream for the treatment of seborrheic dermatitis lesions resistant to conventional treatments.. Sixteen patients with resistant seborrheic dermatitis of the face applied pimecrolimus 1% cream twice daily for 2 weeks. The lesions were assessed clinically and the severity of the signs were assessed using a 4-point score. Additionally, the scores of all affected regions (paranasal, forehead, and eyebrows) were evaluated separately to assess whether different results would be obtained in different regions of the face. Also, patients completed self-assessments on a 100 mm Visual Analogue Scale (VAS) at each visit.. Statistically significant reductions in the scores of all parameters were observed at day 7 and day 14 of the study. There were no significant differences between the responses on the three regions of the face. No adverse effects were reported except for temporary pruritus immediately after the application of pimecrolimus 1% cream in one patient.. Although the interpretation of efficacy was limited by the open-label, non-controlled study design and the small number of patients, this trial suggests that pimecrolimus 1% cream may be a successful treatment choice for patients with resistant seborrheic dermatitis of the face.

Topics: Administration, Cutaneous; Adult; Aged; Dermatitis, Seborrheic; Dermatologic Agents; Face; Female; Humans; Male; Middle Aged; Patient Satisfaction; Retrospective Studies; Sample Size; Severity of Illness Index; Tacrolimus; Time Factors; Treatment Outcome

Seborrheic dermatitis (SD) is a chronic inflammatory disorder that mainly affects the seborrheic region. While ketoconazole is often used, pimecrolimus has been used successfully in SD.. To compare the efficacy and tolerability of pimecrolimus in comparison with ketoconazole in the treatment of SD.. A total of 48 patients with SD were included in the study. Patients were randomized into two groups: 23 and 25 patients in the pimecrolimus and ketoconazole groups, respectively. Clinical measures were assessed by erythema, scaling and infiltration, which were evaluated using a four-point scale (0 to 3) at 2, 6, and 12 weeks.. Of these 48 patients, 38 completed the study (18 and 20 patients in the pimecrolimus and ketoconazole groups, respectively). The mean percentage decrease in clinical severity scores from baseline to the last follow-up period was 86.2% and 86.1% in the pimecrolimus and ketoconazole groups, respectively. Both pimecrolimus and ketoconazole were effective in SD. Differences between the two groups were not statistically significant. Side effects were observed more frequently with pimecrolimus than with ketoconazole and this difference was statistically significant.. Our study showed that pimecrolimus had a comparable efficacy profile with that of ketoconazole, but side effects appeared more frequently in the pimecrolimus group than in the ketoconazole group.

Topics: Adult; Chi-Square Distribution; Dermatitis, Seborrheic; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Ketoconazole; Male; Middle Aged; Ointments; Patient Satisfaction; Probability; Prospective Studies; Reference Values; Risk Assessment; Severity of Illness Index; Tacrolimus; Treatment Outcome; Turkey; Young Adult

Pimecrolimus was found to be effective for the treatment of seborrheic dermatitis in several studies and its off-label use is increasing gradually.. This study was conducted to obtain more detailed information concerning the daily use of pimecrolimus in seborrheic dermatitis and it also aims to contribute to data for the future construction of guidelines.. A total of 52 patients with seborrheic dermatitis enrolled in the study. Pimecrolimus 1% cream was applied twice daily. The mean cure and remission times, detailed responses of each clinical finding and side effects were investigated.. The mean cure and mean remission times were 13.34 and 47.98 days, respectively. Disease severity improved by 50% in between the third and seventh days. Pruritus responded first to pimecrolimus. The drug was equally effective for erythema and scaling. The most frequent side effect was the burning-tingling sensation. After the seventh day of the study, there was no side effect.. Pimecrolimus applications for the treatment of seborrheic dermatitis provide a complete cure in a short period of time and a sustained symptom-free period with low and self-limited side effects.

Topics: Adult; Dermatitis, Seborrheic; Dermatologic Agents; Female; Humans; Male; Pruritus; Tacrolimus

Previous studies have shown that topical steroid and shampoo containing zinc pyrithione provide clinical benefits for treatment of scalp seborrheic dermatitis. But the clinical efficacy of topical tacrolimus, a newly developed calcineurin inhibitor on seborrheic dermatitis, is not well investigated yet. We wanted to compare the clinical efficacy of topical tacrolimus with that of conventional treatment (zinc pyrithione shampoo and topical betamethasone) for treatment of seborrheic dermatitis of the scalp. Patients with seborrheic dermatitis of the scalp were randomly allocated to receive topical betamethasone, topical tacrolimus or zinc pyrithione shampoo. Some patients were instructed to continue the treatments for 8 weeks and the others to discontinue the treatments at week 4. We evaluated the efficacy using a clinical severity score, dandruff score and sebum secretion at baseline, week 4 and week 8. All treatment groups showed significant improvements in clinical assessment after 4 weeks. While the patients treated by zinc pyrithione improved continuously even after cessation of the treatment, the patients treated by betamethasone lotion or tacrolimus ointment were aggravated clinically. Topical tacrolimus was as effective as topical betamethasone, and showed more prolonged remission than topical betamethasone. To treat seborrheic dermatitis of the scalp, we think that the combination therapy of topical steroid or topical tacrolimus, and zinc pyrithione is recommended.

Topics: Administration, Topical; Adult; Antifungal Agents; Betamethasone Valerate; Calcineurin Inhibitors; Dermatitis, Seborrheic; Female; Glucocorticoids; Humans; Male; Middle Aged; Organometallic Compounds; Pyridines; Recurrence; Scalp Dermatoses; Tacrolimus; Time Factors; Young Adult

Seborrhoeic dermatitis is a common, chronic, papulosquamous dermatosis. Treatment of seborrhoeic dermatitis includes topical treatments such as corticosteroids, antifungals, metronidazole and pimecrolimus.. This study aimed to compare and contrast the efficacy and tolerability of pimecrolimus cream 1%, methylprednisolone aceponate 0.1% cream and metronidazole 0.75% gel topical treatments in the treatment of facial seborrhoeic dermatitis.. The study included a total of 64 (32 males and 32 females) consecutive patients with facial seborrhoeic dermatitis. Patients were randomized into three equal groups. One group applied pimecrolimus 1% cream, another group applied methylprednisolone aceponate 0.1% cream, and the third group applied metronidazole 0.75% gel to their facial lesions twice daily for 8 weeks. Assessment of the disease severity was performed at baseline and at weeks 2, 4, and 8. Clinical measures assessed were erythema, scaling and pruritus, which were evaluated using a four-point scale (0-3).. Of the 64 patients, 17 (80%) in the metronidazole group, 21 (100%) in the pimecrolimus group and 22 (100%) in the methylprednisolone aceponate group completed the study. Four patients in the metronidazole group left the study. All of the therapeutic agents were found to be effective; however, the efficacy of pimecrolimus was higher than those of metronidazole and methylprednisolone (p < 0.05). When side effects associated with pimecrolimus and metronidazole were compared, the latter was found to be associated with more side effects (p < 0.05).. We suggest pimecrolimus to be a therapeutic option for seborrhoeic dermatitis cases that show an unfavourable response to methylprednisolone aceponate.

Topics: Administration, Cutaneous; Adolescent; Adult; Anti-Infective Agents; Anti-Inflammatory Agents, Non-Steroidal; Dermatitis, Seborrheic; Dermatologic Agents; Drug Therapy, Combination; Emollients; Face; Female; Humans; Male; Methylprednisolone; Metronidazole; Patient Satisfaction; Severity of Illness Index; Tacrolimus; Treatment Outcome

Seborrheic dermatitis is commonly treated with anti-inflammatory products, including topical corticosteroids. Pimecrolimus cream 1% also exerts anti-inflammatory activity by inhibiting T-cell cytokine production.. We sought to compare the efficacy and safety of twice-daily pimecrolimus for treatment of moderate to severe facial seborrheic dermatitis.. This double-blind, vehicle-controlled, 4-week trial randomized patients with seborrheic dermatitis to pimecrolimus or vehicle (1:1). Clinical assessments (erythema [0-3] and scaling [0-3] combined for a total area score [0-6]) were performed at weeks 0, 2, and 4. Inclusion criteria included total area score 4 or greater and erythema 2 or greater. The prespecified primary variable, change from baseline in total area score at week 4, was analyzed using a two-sample t test for intent-to-treat and per protocol populations.. In all, 96 adults of mean age 59.6 years, 88.5% male, were randomized (n = 47 pimecrolimus; 49 vehicle). At week 4, the mean change from baseline in total area score was 3.7 versus 3.3 for pimecrolimus and vehicle groups, respectively (intent-to-treat: P = .1913; 95% confidence interval (CI) for difference [-0.195, 0.961]). Per protocol analysis (n = 41 pimecrolimus; 46 vehicle) indicated a significant difference between groups (mean change 3.9 pimecrolimus vs 3.2 vehicle; P = .0156; CI [0.129, 1.197]). The superiority of pimecrolimus was observed as early as week 2 (intent-to-treat: P = .0062; CI [0.132, 0.777]; per protocol: P = .0012; CI [0.410, 1.593]). No drug-related serious adverse events occurred. The most frequent drug-related adverse events were local, mild, and transient (pimecrolimus = 26%; vehicle = 12%).. Generalizability is limited by the elderly male study population.. This study suggests that pimecrolimus cream 1% is an effective and well-tolerated treatment for moderate to severe facial seborrheic dermatitis.

Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Dermatitis, Seborrheic; Double-Blind Method; Drug Administration Schedule; Drug Eruptions; Facial Dermatoses; Female; Humans; Male; Middle Aged; Patient Satisfaction; Severity of Illness Index; Tacrolimus; Treatment Outcome

Pimecrolimus cream 1% has shown to be effective in patients with a variety of inflammatory cutaneous disorders. And it might be a useful modality in the treatment of seborrheic dermatitis. This prospective study was aimed at assessing the efficacy and tolerability of pimecrolimus cream 1% in the treatment of facial seborrheic dermatitis. Twenty patients were instructed to apply pimecrolimus cream 1% for 4 consecutive weeks. Assessment of the disease severity was performed at baseline and at week 1, 2, and 4. Clinical assessments of erythema, scaling, and pruritus were measured using a 4-point scale (0-3). Global assessments of the disease severity by patients and investigators were performed at each visit. Mean clinical scores of erythema, scaling, and pruritus significantly improved by 87.4%, 91.9%, and 91.5% respectively at week 4 (p<0.001). Improvements in the global assessment of disease severity determined by patients and investigators also showed excellent results. No specific adverse events other than transient burning and tingling sensations were noted. The relapse of facial seborrheic dermatitis was mostly observed between 3 to 8 weeks after the discontinuation of pimecrolimus. We suggest that the topical application of pimecrolimus cream 1% can be an effective and safe alternative for treatment of facial seborrheic dermatitis.

Topics: Adult; Aged; Dermatitis, Seborrheic; Erythema; Face; Female; Follow-Up Studies; Humans; Korea; Male; Middle Aged; Severity of Illness Index; Tacrolimus; Time Factors; Treatment Outcome

Topics: Administration, Cutaneous; Adult; Calcineurin Inhibitors; Dermatitis, Seborrheic; Dermatologic Agents; Facial Dermatoses; Female; Humans; Hydrocortisone; Male; Peptidylprolyl Isomerase; Severity of Illness Index; Single-Blind Method; Tacrolimus; Treatment Outcome

Seborrhoeic dermatitis is a chronic inflammatory disease with remissions and exacerbations, characterized by erythema, scaling and pruritus primarily on the face, scalp and chest. Corticosteroids and antifungals are the mainstay of therapy. However, chronic use of corticosteroids is associated with side-effects such as skin atrophy and telangiectasia. Pimecrolimus, an inhibitor of calcineurin, has been used successfully in one patient with seborrhoeic dermatitis.. The objective of this randomized open-label clinical trial was to compare the efficacy and tolerability of pimecrolimus in comparison with a potent corticosteroid (betamethasone 17-valerate) in the treatment of seborrhoeic dermatitis.. Twenty patients with seborrhoeic dermatitis were included in this study, 11 patients in the pimecrolimus 1% cream group and nine patients in the betamethasone 17-valerate 0.1% cream group. Patients were instructed to use a thin layer of the study products twice daily at the lesional area and to discontinue treatment as soon as symptoms were absent. Clinical measures assessed were erythema, scaling and pruritus which were evaluated using a four-point scale (0-3).. Both pimecrolimus and betamethasone were highly effective in the treatment of seborrhoeic dermatitis. Betamethasone reduced all three parameters, erythema, scaling and pruritus, faster than pimecrolimus, but the differences in reduction were not statistically significant. Relapses were observed more frequently and were more severe with betamethasone than with pimecrolimus. Moreover, pruritus was not observed after discontinuation of treatment from day 15 and beyond in the pimecrolimus group, whereas it was reported in most patients of the betamethasone group. This difference was statistically significant.. It appears that pimecrolimus, a nonsteroidal topical treatment, may be an excellent alternative therapeutic modality for treating seborrhoeic dermatitis.

Topics: Administration, Cutaneous; Adult; Betamethasone; Calcineurin Inhibitors; Dermatitis, Seborrheic; Dermatologic Agents; Erythema; Female; Follow-Up Studies; Humans; Male; Middle Aged; Pruritus; Recurrence; Severity of Illness Index; Tacrolimus; Treatment Outcome

The ascomycin macrolactam derivative pimecrolimus is a novel, nonsteroidal, cell-selective inhibitor of inflammatory cytokines specifically developed for the treatment of inflammatory skin diseases. Our objective was to assess the efficacy, tolerability and safety of pimecrolimus cream 1% in the treatment of seborrheic dermatitis. Adults with seborrheic dermatitis of the face and upper trunk who were seen from October 2003 to April 2004 at the Dermatologic Outpatient Clinic of the University of Thrace were enrolled in this 9-week open-label uncontrolled study. Pimecrolimus cream 1% was applied as monotherapy twice daily for 7 days and for an additional period of 7 days thereafter, if needed, until complete clearance was achieved. In cases of recurrence a 5-day course was additionally applied. After screening and an appropriate washout period, subjects were evaluated at baseline (day 0) and at follow-up visits at weeks 1, 3, 6 and 9. The clinical severity of seborrheic dermatitis was estimated as mild (total score 1-3), moderate (total score 4-6) and severe (total score 7-9) in terms of erythema, scaling and lesional extent using a scale from 0 to 3 for each. Patients also assessed their symptoms on a scale from 0 to 5 in terms of the efficacy, safety and tolerability of topical application. Nineteen patients (12 males, seven females) were enrolled in this study. At the end of weeks 1, 3, 6 and 9 the percentages of complete clearance were 63%, 100%, 47% and 52%, respectively. At the end of the study, subjects' average assessment score was 9.73. Apart from topical burning and irritation of the skin in four patients, no other adverse event was mentioned. This pilot study indicates that pimecrolimus applied twice daily can be a safe and efficacious alternative in the treatment of seborrheic dermatitis. Further studies are needed to determine the initial and maintenance therapy.

Topics: Adolescent; Adult; Dermatitis, Seborrheic; Face; Female; Follow-Up Studies; Humans; Male; Ointment Bases; Pilot Projects; Tacrolimus

As a topical immunosuppressant, tacrolimus ointment may be beneficial in the treatment of seborrhoeic dermatitis, while avoiding adverse effects related to long-term use of topical corticosteroids.. To determine the safety and efficacy of topical tacrolimus 0.1% ointment in the treatment of seborrhoeic dermatitis.. Sixteen subjects (15 men and one woman) were enrolled in a 6-week, open-label, uncontrolled trial of daily topical tacrolimus 0.1% ointment. Following a 2-week washout period for subjects using conventional therapy for seborrhoeic dermatitis, study medication was applied nightly to affected areas until clinical clearance occurred, and then for 7 days thereafter. Lesional extent and severity were assessed at baseline (day 0), at week 2 and at week 6 using the following parameters: (i). clinical assessment of erythema and scaling using a 0-3 scale; (ii). investigator global assessment; (iii). subject global assessment using a 0-6 scale; and (iv). serial photography.. Thirteen of 16 (81%) subjects completed the study protocol; three subjects were lost to follow-up at week 6. Relative to the mean baseline value, the mean lesional erythema scores improved by 66.1% and 70.9% at weeks 2 and 6, respectively. Compared with baseline, the mean scaling scores improved by 63.7% at week 2 and 87.8% at week 6. These observations were statistically significant (P < 0.05, Wilcoxon two-sample test). Mean investigator global assessment scores improved by 76.6% at week 2 and 82.7% at week 6, relative to the mean baseline value. Mean subject global assessment scores also improved, by 69.4% at week 2 and 83.5% at week 6, relative to the mean baseline value. Other than transient application site pruritus/burning in two subjects, no serious adverse events were observed.. This pilot study suggests that topical tacrolimus 0.1% ointment is efficacious in the short-term treatment of seborrhoeic dermatitis. Further controlled trials are warranted, to determine its efficacy and safety for this common condition.

Topics: Administration, Topical; Adult; Aged; Dermatitis, Seborrheic; Dermatologic Agents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Ointments; Pilot Projects; Tacrolimus; Treatment Outcome

Seborrheic dermatitis is generally treated with topical steroids, antifungals, or both. This pilot study was undertaken to examine the possibility of tacrolimus as a useful therapy for seborrheic dermatitis. In a single-center, open-label study, 18 consecutive patients with seborrheic dermatitis were treated with 0.1% tacrolimus for a total of 28 days or until complete clearance occurred, if sooner. Of the patients, 11 (61%) showed 100% clearance of their seborrheic dermatitis; the remaining 7 patients showed 70% to 99% clearance. The most common side effects were mild local burning and irritation.

Topics: Adult; Aged; Aged, 80 and over; Dermatitis, Seborrheic; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Ointments; Pilot Projects; Recurrence; Tacrolimus

Malassezia restricta is the most predominant fungus in the microbiome of human skin. This microorganism can cause or exacerbate Malassezia-associated skin dermatitis, seborrheic dermatitis, atopic dermatitis, and pityriasis versicolor. The virulence factors of M. restricta have not been analyzed because a gene recombination system has not been developed. In this study, we established an Agrobacterium tumefaciens-mediated gene transfer (ATMT) system, optimized for generating gene-deficient mutants of M. restricta. A mutant of FKB1 gene, which encodes the FKBP12 protein that binds to the calcineurin inhibitor tacrolimus, was generated using the ATMT system. Subsequently, the FKB1 gene was reintroduced into the FKB1 gene-deficient mutant for obtaining a gene-complemented strain. The wild-type strain of M. restricta was sensitive to tacrolimus, whereas the FKB1 gene-deficient mutant was resistant to tacrolimus; the phenotypic drug susceptibility in the mutant was restored by reintroducing the FKB1 gene. Contrastingly, the FKB1 gene-deficient mutant was not resistant to cyclosporine A, which also inhibits calcineurin by binding to cyclophilin A. The gene recombination system for M. restricta will facilitate in elucidating the molecular mechanisms causing Malassezia-associated dermatitis.

Topics: Agrobacterium tumefaciens; Animals; Dermatitis, Seborrheic; Fungi; Humans; Malassezia; Recombination, Genetic; Tacrolimus

Seborrheic dermatitis (SD) is a common inflammatory skin condition. The etiology is unclear, although overgrowth of Malassezia on the skin has been suggested to cause SD. This study investigated whether colonization with Staphylococcus plays a role in facial SD, which was not well addressed previously.. The study was conducted from September 1, 2011 to February 20, 2012 in the First Hospital of China Medical University. In the first phase, the study evaluated the level of transepidermal water loss (TEWL) and the number of colony-forming units (CFU) of Staphylococcus in defined skin areas of SD patients who were human immunodeficiency virus (HIV) seropositive (HIV [+] SD [+] group, n = 13), classical SD (HIV [-] SD [+] group, n = 24) patients, HIV seropositive-non-SD (HIV [+] SD [-] group, n = 16) patients, and healthy volunteers (HIV [-] SD [-] group, n = 16). In the second phase, we enrolled another cohort of HIV (-) SD (+) patients who applied topical fusidic acid (n = 15), tacrolimus (n = 16), or moisturizer (n = 12). Changes in the Seborrheic Dermatitis Area Severity Index (SDASI), TEWL, and Staphylococcus density were evaluated 2 weeks later. Comparisons of each index were performed using analysis of variance (ANOVA) and least significant difference method.. The level of TEWL was greater through lesional sites in the HIV (+) SD (+) group than that in HIV (+) SD (-) and HIV (-) SD (-) groups (95% confidence interval [CI]: 18.873-47.071, P < 0.001 and 95% CI: 28.755-55.936, P < 0.001, respectively). The number of CFU of Staphylococcus was greater in the HIV (+) SD (+) group than that in HIV (+) SD (-) and HIV (-) SD (-) groups (95% CI: 37.487-142.744, P = 0.001 and 95% CI: 54.936-156.400, P < 0.001, respectively). TEWL was significantly more improved in patients treated with tacrolimus and fusidic acid than that in those treated with moisturizers (95% CI: 7.560-38.987, P = 0.004 and 95% CI: 4.659-37.619, P = 0.011, respectively). Topical tacrolimus and fusidic acid were significantly associated with decreased SDASI as compared with moisturizer (95% CI: 0.03-0.432, P = 0.025 and 95% CI: 0.033-0.44, P = 0.024, respectively).. High colonization with Staphylococcus epidermidis, along with impaired skin permeability barrier function, contributes to the occurrence of SD.

Topics: Dermatitis, Atopic; Dermatitis, Seborrheic; Fusidic Acid; HIV; Humans; Skin; Staphylococcus epidermidis; Tacrolimus

Seborrheic dermatitis (SD) tends to reoccur frequently, so the therapeutic agent must have a high benefit versus adverse effect ratio for long-term and repetitive uses.. To assess the efficacy and safety of retreatment with pimecrolimus in SD patients.. A total of 45 patients who had been treated previously with pimecrolimus 1% cream were retreated with the same agent using the same treatment protocol after the disease reoccurred. The first and the second treatments were compared with regard to disease severity before treatment, complete cure times, remission times and side effects.. The median severities of the disease were 5 and 4 before the first and second treatments, respectively. Retreatment of the disease with pimecrolimus resulted in shorter cure and longer remission times. Side effects were seen only on the first day of the retreatment and an increase in erythema was seen in fewer patients.. Retreatment of the recurrence of SD with pimecrolimus as monotherapy is an effective and safe approach in the management of the disease.

Topics: Administration, Topical; Adult; Dermatitis, Seborrheic; Dermatologic Agents; Facial Dermatoses; Female; Humans; Male; Ointments; Recurrence; Retreatment; Severity of Illness Index; Statistics, Nonparametric; Tacrolimus; Treatment Outcome

Tinea incognito was first described 50 years ago. It is a dermatophytic infection with a clinical presentation modified by previous treatment with topical or systemic corticosteroids, as well as by the topical application of immunomodulators such as pimecrolimus and tacrolimus. Tinea incognito usually resembles neurodermatitis, atopic dermatitis, rosacea, seborrheic dermatitis, lupus erythematosus, or contact dermatitis, and the diagnosis is frequently missed or delayed.

Topics: Administration, Cutaneous; Antifungal Agents; Dermatitis, Atopic; Dermatitis, Contact; Dermatitis, Seborrheic; Dermatologic Agents; Diagnosis, Differential; Humans; Immunosuppressive Agents; Lupus Erythematosus, Discoid; Neurodermatitis; Ointments; Rosacea; Tacrolimus; Tinea; Trichophyton

Topics: Administration, Topical; beta-Thalassemia; Bone Marrow Transplantation; Chemotherapy, Adjuvant; Child; Chronic Disease; Combined Modality Therapy; Dermatitis, Seborrheic; Dermatologic Agents; Follow-Up Studies; Graft vs Host Disease; Humans; Male; Radiotherapy, Adjuvant; Severity of Illness Index; Tacrolimus; Treatment Outcome

Seborrhoeic dermatitis (SD) is a common dermatosis in human immunodeficiency virus (HIV)-positive patients, many of whom do not respond satisfactorily to conventional topical treatments such as corticosteroids and antifungals.. A pilot study to investigate the efficacy and tolerability of pimecrolimus cream 1% in HIV-positive patients with facial SD.. In a single-centre study, 21 HIV-infected patients with mild to severe SD were treated twice daily with pimecrolimus cream 1% for 14 days. Thereafter, treatment was discontinued and patients followed up for 5 weeks. Skin involvement at baseline and on days 7, 14, 21, 35 and 49 was assessed using a four-point clinical score and digital photography.. Efficacy and safety of pimecrolimus cream 1% treatment and incidence of relapse in the follow-up phase. Results Marked improvement was seen in clinical parameters at day 7, with >or= 90% patients clear of symptoms at day 14. Relapse was observed at day 35 but signs were milder than at baseline. All patients responded to therapy, despite their immunological status. Pimecrolimus did not alter CD4(+) and CD8(+) T-cell counts or viral load during the treatment period.. Pimecrolimus cream represents a new, effective therapeutic option for facial SD in HIV patients.

Topics: Administration, Topical; Adult; Dermatitis, Seborrheic; Dermatologic Agents; Facial Dermatoses; Female; HIV Infections; Humans; Male; Middle Aged; Ointments; Pilot Projects; Recurrence; Tacrolimus; Treatment Outcome

Topics: Adult; Animals; Dermatitis, Seborrheic; Dermatologic Agents; Facial Dermatoses; Humans; Male; Mite Infestations; Mites; Rosacea; Skin; Tacrolimus

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents, Non-Steroidal; Dermatitis, Seborrheic; Female; Humans; Infant; Tacrolimus

African Americans with seborrheic dermatitis may manifest associated hypopigmenation. Corticosteroids and antifungals are often used for treatment, yet chronic use of corticosteroids may be associated with skin atrophy, increased intraocular pressure, or further hypopigmenation. Pimecrolimus has been used successfully in a few patients with seborrheic dermatitis.. This open-label, pilot trial assessed the efficacy and tolerability of pimecrolimus in the treatment of seborrheic dermatitis in African Americans with hypopigmentation.. Five African American adults with seborrheic dermatitis used a thin layer of pimecrolimus on the involved areas twice per day for 16 weeks. Clinical measures of improvement included erythema, scaling, and pruritus. Hypopigmentation was measured objectively using a mexameter.. All participants noted a marked decrease in the severity of their condition. An improvement in hypopigmentation was also noted. For all indicators, the magnitude of improvement was most marked during the initial 2 weeks of treatment.. This was an open-label pilot trial limited to just 6 participants, only 5 of whom completed the study.. Topical pimecrolimus cream may be an excellent alternative therapeutic modality for treating seborrheic dermatitis in African Americans, particularly in those with associated hypopigmentation.

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Black or African American; Dermatitis, Seborrheic; Dosage Forms; Female; Humans; Hypopigmentation; Male; Middle Aged; Pilot Projects; Tacrolimus

Topics: Acquired Immunodeficiency Syndrome; Administration, Topical; Adult; Dermatitis, Seborrheic; Humans; Immunosuppressive Agents; Male; Psoriasis; Sarcoma, Kaposi; Skin Neoplasms; Tacrolimus

Topics: Administration, Topical; Adult; Dermatitis, Seborrheic; Dermatologic Agents; Drug Eruptions; Facial Dermatoses; Humans; Male; Ointments; Rosacea; Tacrolimus

Seborrheic dermatitis is a chronic inflammatory disease that mainly affects seborrheic areas of skin. An inflammatory response to the yeast Pityrosporum ovale has been thought to be important in the etiology of the condition. Therefore, topical antifungals and corticosteroids have been the mainstay of treatment. The recent development of topical macrolactam immunomodulators has offered a useful, safe alternative to corticosteroids in the treatment of various inflammatory skin disorders. We report successful treatment of seborrheic dermatitis with pimecrolimus.

Topics: Administration, Topical; Adolescent; Calcineurin Inhibitors; Dermatitis, Seborrheic; Dermatologic Agents; Face; Female; Humans; Immunosuppressive Agents; Tacrolimus

Seborrheic dermatitis is a chronic recurrent inflammatory skin condition that mainly affects areas containing sebaceous glands. I present a case of a novel effective topical nonsteroidal treatment (pimecrolimus 1.0% cream) for facial seborrheic dermatitis. Pimecrolimus is a member of a new class of nonsteroidal agents- macrolactam immunomodulators.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents, Non-Steroidal; Dermatitis, Seborrheic; Dermatologic Agents; Drug Evaluation; Humans; Male; Tacrolimus; Treatment Outcome