Pimecrolimus Group Research Articles

The efficacy and safety of pimecrolimus 1% cream vs. sertaconazole 2% cream in the treatment of patients with facial seborrhoeic dermatitis: a randomized blinded trial.

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.

Effect of pimecrolimus on postoperative peritoneal adhesions in rat: An experimental study

IntroductionPostoperative peritoneal adhesions (PPAs) is a common complication of abdominal surgeries causing significant morbidity and mortality. The inflammatory response to damaged peritoneal tissue is a speculated culprit. The aim of this study is to investigate the protective effect of pimecrolimus, an anti-inflammatory and immunomodulator agent, in formation of PPAs in rats. MethodsComplied with the Animal Research Reporting In Vivo Experiments (ARRIVE) Guidelines Checklist, 50 Albino rats underwent laparotomy and were allocated into 5 groups. In groups 1 to 3, topical pimecrolimus (25, 50 and 100% concentration, respectively) was applies on a scratched area of peritoneum. In group 4, only topical Eucerin was used and group 5, was the control group. On postoperative days 7 and 28, five rats from each group were randomly selected and the tensile strength and adhesiveness of intraabdominal fibrotic bundles were assessed. ResultsThere was no significant difference in tensile strength and adhesiveness, between the groups on postoperative day 7. On postoperative day 28, however, the tensile strength was significantly lower in pimecrolimus groups than in Eucerin (<0.001) and control (<0.001) groups. Groups with higher concentrations of pimecrolimus (group 2 and 3) developed significantly less adhesions than group 1, in which lower pimecrolimus concentration was used. ConclusionAdministration of topical pimecrolimus decrease adhesions and their tensile strength on postoperative day 28 in rats.

Efficacy of the Topical Calcineurin Inhibitors Tacrolimus and Pimecrolimus in the Treatment of Vitiligo in Infants Under 2Years of Age: A Randomized, Open-Label Pilot Study.

The efficacy of topical calcineurin inhibitors (TCIs) for the treatment of infants with vitiligo aged less than 2years remains to be fully determined. This aim of this pilot study was to assess the efficacy and tolerability of the TCIs tacrolimus and pimecrolimus in infants with vitiligo aged under 2years. Infants with vitiligo aged < 2years were randomly assigned to receive either tacrolimus ointment 0.03% or pimecrolimus cream 1% for a period of 6months. During this period, topical treatment was applied twice daily. The proportion of body surface area of the treated lesions, locations, and possible adverse effects were recorded. In addition, the overall satisfaction scores of the patients' parents was evaluated by virtue of the visual analog scale (VAS). Forty-six infants with vitiligo were enrolled in this study. The overall response rate (> 0% repigmentation) was 100%, while the effectiverate (> 50% repigmentation) of the tacrolimus and pimecrolimus groups was 69.6% and 65.2%, respectively. Meanwhile, the effective rates for vitiligo located on the head and neck, trunk, and extremities were 70%, 64.3% and 50%, respectively, while the response rates for non-segmental and segmental vitiligo were 74.4% and 28.6%, respectively. Only a low incidence of local adverse reactions (including mild redness and skin picking) was reported during the treatment process. Topical tacrolimus ointment 0.03% or pimecrolimus cream 1% have efficacy for vitiligo in infants, which serves to achieve an appropriate level of safety and tolerability during the 6-month period of applications. Thus, TCIs proved to be a therapeutic option for vitiligo in infants under 2years of age.

Epidermal Growth Factor Relieves Inflammatory Signals in Staphylococcus aureus-Treated Human Epidermal Keratinocytes and Atopic Dermatitis-Like Skin Lesions in Nc/Nga Mice.

Atopic dermatitis (AD) is a chronic inflammatory skin disease with a defective immunologic barrier, which is aggravated by Staphylococcus aureus (S. aureus). Epidermal growth factor (EGF) suppresses inflammation and EGF receptor inhibitors increased S. aureus colonization. Thus, we investigated the potential roles of EGF in AD, which is often aggravated by S. aureus. We determined how EGF affects the expression of inflammatory cytokines and antimicrobial peptides (AMPs) in human epidermal keratinocytes (HEKs) treated with heat-inactivated S. aureus (HKSA) in vitro and 2,4-dinitrochlorobenzene-induced AD-like skin lesions in Nc/Nga mice. HKSA increased IL-6 and NFκB expression; EGF treatment had the opposite effect. EGF increased human β defensin-2 expression in HEKs and murine β defensin-3 in mice. In mice, both EGF and pimecrolimus groups showed less erythema with significantly reduced inflammation and decreased expression of thymic stromal lymphopoietin. EGF relieved S. aureus-induced inflammation and AD-like skin lesions in Nc/Nga mice. Therefore, EGF could be a potential topical treatment for AD.

Preparation and Characterization of Novel Pimecrolimus Nanoparticles for Therapy of Allergic Conjunctivitis.

Pimecrolimus is a novel anti-inflammatory drug for treating allergic conjunctivitis. However, its high hydrophobicity is the bottleneck for clinical application on anti-allergic conjunctivitis. Although ongoing efforts have been made to increase its hydrophilicity through hydration, the results are discouraging. Now, we developed the nanoparticle-encapsule of pimecrolimus in a new material synthesized from polymannuronic acid and oleyl amine. The drug loading and encapsulation efficiency of pimecrolimus nanoparticle were measured by high-performance liquid chromatography, which were 12.38±0.04% and 94.58±0.07%, respectively. The mean particle size of pimecrolimus nanoparticle was 193.1±2.62 nm and polydisperse index was 0.176±0.018. Its spherical and homogeneous appearance were observed by transmission electron microscope. Furthermore, a mouse model of allergic conjunctivitis has been established to evaluate the efficacy of pimecrolimus nanoparticle. Treatment progress with clinical scoring and morphology of the conjunctiva histology were assessed in detail. The results have demonstrated that pimecrolimus nanoparticle could significantly relieve the inflammation signs of allergic conjunctivitis model mice and repair ocular surface goblet cells after a week of treatment twice a day. The improvement rate and inflammatory cell inhibition rate of the free pimecrolimus group versus pimecrolimus nanoparticle group were (49.18% vs. 71.26%), (67.43% vs. 81.18%), respectively. Such data further demonstrated pimecrolimus nanoparticle could be a good candidate as a promising ophthalmic agent for treating allergic conjunctivitis, meanwhile, a novel biodegradable seaweed polysaccharide derivative should be a potential carrier for lipophilic drug.

295 Epidermal growth factor relieves inflammatory signals in Staphylococcus aureus treated human epidermal keratinocytes and atopic dermatitis-like skin lesions in Nc/Nga mice

Atopic dermatitis (AD) is a very common chronic inflammatory skin disease with defective immunologic barrier necessitating various topicals in addition to systemic treatments, but topical treatments are still unsatisfactory. A well-known facilitator of wound healing, epidermal growth factor (EGF) was also shown to inhibit inflammation and EGF receptor inhibitors increased Staphylococcus aureus (S. aureus). Thus, we investigated potential roles of EGF treatment in AD which is often aggravated by infection of S. aureus. We experimented how EGF work on expression of inflammatory cytokines and antimicrobial peptides (AMPs) in human epidermal keratinocyte (HEK) treated with heat-inactivated S. aureus (HKSA) in vitro and 2,4 dinitrochlorobenzene (DNCB) induced AD-like skin lesions in Nc/Nga mice. HKSA-induced IL-6 and NFκB expression and mRNA levels of p38 and EGF treatment reduced the level of these. Intriguingly, EGF increased the expression of human β defensin-2 (hBD-2) in HEK. In mice, both EGF and pimecrolimus groups showed less erythema with significantly decreased infiltrates of inflammatory cells and CD3+ T cells and decreased expression of thymic stromal lymphopoietin (TSLP) compared with untreated controls at 3 hr and 24 hr. TSLP expression was much more reduced in EGF group than in pimecrolimus group. In both EGF and pimecrolimus groups, murine β defensing-3 (mBD-3) was increased compared to the controls. EGF contributed to relieve inflammatory signals induced by S. aureus and AD-like skin lesions in Nc/Nga mice. Considering that AD is characterized by decreased AMPs with defective innate immune function leading to uncontrolled inflammation, EGF may be a potential topical treatment option in AD.

Efficacy and Safety of Tacrolimus versus Pimecrolimus for the Treatment of Atopic Dermatitis in Children: A Network Meta-Analysis

Objective: Using a network meta-analysis, we aimed to compare the efficacy and safety of tacrolimus and pimecrolimus as treatment options for children with atopic dermatitis (AD). Methods: Randomized controlled studies with a modified Jadad score >3 using tacrolimus or pimecrolimus in pediatric patients with AD were studied. Results: Out of 163 articles, 19 studies enrolling a total of 6,413 pediatric patients were selected. Pooled analysis revealed that tacrolimus 0.03% or 0.1% and pimecrolimus 1% were better at reducing eczema compared with vehicles. No significance was found between tacrolimus and pimecrolimus in improving the severity of eczema. More patients tended to withdraw in the vehicle groups compared to the tacrolimus and pimecrolimus groups. No significant difference existed between total adverse events and withdrawals in the tacrolimus and pimecrolimus groups. Conclusions: Pimecrolimus was similar to tacrolimus in both efficacy and safety for AD in children, but both were better than vehicles.

Comparison of topical application of tea polyphenol versus pimecrolimus versus tacrolimus for the treatment of monobenzone-induced vitiligo-like depigmentation in a mouse model

Objective To compare the therapeutic effect of topical application of tea polyphenol versus pimecrolimus versus tacrolimus for monobenzone-induced vitiligo-like depigmentation in mice. Methods Twenty-five 3-week-old female C57BL/6 mice were randomly and equally divided into 5 groups: negative control group, model group, tea polyphenol group, pimecrolimus group, tacrolimus group. Monobenzone 45% cream was applied to the back of mice in all the five groups except the negative control group once daily for 40 consecutive days to establish a model of vitiligo-like depigmentation. During the induction of depigmentation, the tea polyphenol group, pimecrolimus group and tacrolimus group were topically treated with tea polyphenol, pimecrolimus and tacrolimus respectively, and the model group remaining untreated. The depigmentation of hairs and skin was observed by naked eyes on a daily basis. Tissue specimens were obtained for histological examination from depigmented skin at non-application sites in mice after the end of the experiment. Hematoxylin-eosin staining was conducted to analyze lymphocytic infiltration, reflectance confocal microscopy to observe melanin and melanocytes in skin, and immunofluorescence assay to detect CD8+ T cell infiltration. Results Depigmentation occurred in both application sites and non-application sites of mice in the model group. Compared with the model group, the tacrolimus, pimecrolimus and tea polyphenol groups showed delayed depigmentation, reduced degree and area index of depigmentation, and attenuated lymphocytic infiltration and CD8+ T cell infiltration in depigmented maculae at application sites. In addition, the therapeutic effect of tacrolimus was stronger than that of pimecrolimus and tea polyphenol. Conclusion Tea polyphenol, pimecrolimus and tacrolimus are all effective for the treatment of vitiligo-like depigmentation in mice. Key words: Monobenzone; Tea polyphenol; Tacrolimus; Pimecrolimus; Vitiligo, animal model

Relative efficacy of pimecrolimus cream and triamcinolone acetonide paste in the treatment of symptomatic oral lichen planus.

Background and Objectives:Oral lichen planus (OLP) is a relatively common, chronic inflammatory condition that frequently presents with symptoms of pain and burning sensation. It is generally a very unrelenting disorder despite several kinds of treatment. Only symptomatic OLP requires treatment, and it remains a challenging predicament. Efforts are made in a sustained manner for searching for novel therapies for symptomatic OLP. Therefore, this study was aimed to compare the efficacy of treatment with topical pimecrolimus cream 1% with that of triamcinolone acetonide oral paste 0.1% in subjects with symptomatic OLP.Materials and Methods:A prospective, parallel-group, randomized, active control clinical study was conducted among 30 symptomatic OLP subjects (20 females and 10 males, with 15 patients in each treatment group) treated with topical pimecrolimus 1% cream and triamcinolone acetonide 0.1% oral paste four times daily for two consecutive months and treatment-free follow-up was performed for 2 months. Pain or burning sensation, mean clinical score and presence of erythematous areas were assessed. The data obtained were statistically analyzed using Wilcoxon's Rank test and the Mann Whitney test.Results:Subjects in both the groups showed significant improvement in symptom scores; however, the overall treatment response was higher in the pimecrolimus group compared with the triamcinolone acetonide group. On intergroup comparison, there was no statistically significant difference between the groups in the reduction in burning sensation (P = 0.18) and erythematous area (P = 0.07), but there was a statistically highly significant improvement in reduction of clinical scoring (P < 0.01%). Following the termination of the treatment, sustained remission of symptoms and long-lasting therapeutic effects was detected in 93.3% of the patients treated with pimecrolimus.Interpretation and Conclusion:Topical pimecrolimus 1% cream showed better therapeutic response compared with triamcinolone acetonide 0.1% oral paste in subjects with symptomatic OLP.

Topical pimecrolimus inhibits high-dose UVB irradiation-induced epidermal Langerhans cell migration, via regulation of TNF-α and E-cadherin.

BackgroundTopical pimecrolimus has been shown to reverse epidermal CD1a+ Langerhans cell reduction induced by high-dose ultraviolet (UV)B irradiation, but the mechanism is still unclear. This study aimed to investigate the possible mechanism of the effect of pimecrolimus on high-dose UVB-irradiated epidermal Langerhans cells.MethodsForty human foreskin tissues were divided into four groups: control; pimecrolimus-only; UVB-only; and UVB + pimecrolimus. All tissues were cultured, and each tissue was cut into four pieces, corresponding to four time points (0 hours, 18 hours, 24 hours, and 48 hours). We collected the tissues and culture medium at each time point. The percentage of CD1a+ cells in medium was detected by flow cytometry. The tissues were detected for messenger (m)RNA and protein expression of tumor necrosis factor (TNF)-α, interleukin (IL)-1β, and E-cadherin, by reverse-transcription polymerase chain reaction (PCR) and Western blot.ResultsAt 18 hours, 24 hours, and 48 hours, the CD1a+ cells in the culture medium of the UVB-only group and the UVB + pimecrolimus group were significantly more than in the control group, while the CD1a+ cells of the UVB + pimecrolimus group was less than of the UVB-only group. For both the UVB-only group and UVB + pimecrolimus group, TNF-α expression (by both reverse-transcription PCR and Western blot) of the tissues was clearly higher and E-cadherin expression was significantly lower compared with the control group, at 18 hours, 24 hours, and 48 hours. For the UVB + pimecrolimus group, TNF-α was clearly lower and E-cadherin was significantly higher compared with the UVB-only group.ConclusionTopical pimecrolimus inhibited epidermal Langerhans cell migration induced by high-dose UVB irradiation, via regulation of TNF-α and E-cadherin.

Treatment of seborrheic dermatitis: comparison of sertaconazole 2 % cream versus pimecrolimus 1 % cream

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.

Pimecrolimus kremin (%1) atopik dermatit tedavisindeki etkinliği

SummaryBackgroundIn recent years, pimecrolimus 1% cream has been demonstrated to reduce symptoms of atopic dermatitis in patients when applied topically.Material/MethodsIn our study we compared the therapeutic effects of local 1% pimecrolimus to 1% hydrocortisone, and to a control group in a mouse model with atopic dermatitis in the external ear canals. Atopic dermatitis was created by application of Dinitrochlorobenzene in the external ear canals of mice. The development of atopic dermatitis was detected by clinical observation score and determination of total serum IgE levels. Pimecrolimus and hydrocortisone cream were topically applied to the external ear canal skin once a day for 14 days.ResultsThere was no significant difference between the hydrocortisone and the pimecrolimus therapy groups, while there was a statistically significant difference between these 2 groups and the control group (p<0.05) Assessment of the clinical observation scoring carried out on the 14th day of therapy revealed that there was no difference between the hydrocortisone and pimecrolimus groups. Biopsies were taken on the 14th day following treatment. Tissue samples were histologically evaluated; contact dermatitis was observed microscopically in the control group, but in the therapy groups only minimal evidence of contact dermatitis was found.ConclusionsThe results of our study reveal that the therapeutic efficacy of 1% pimecrolimus was equivalent to 1% hydrocortisone treatment in the artificially developed atopic dermatitis model in external ear canals of mice. These results clearly demonstrate that 1% pimecrolimus cream can be an effective alternative therapeutic agent in cases where steroid treatment proves to be insufficient or in cases where treatment must be discontinued due to its adverse effects.

Efficacy of pimecrolimus 1 % cream in the long term management of atopic hand dermatitis. A double‐blind RCT

Efficacy and steroid sparing effects of pimecrolimus 1% cream in atopic dermatitis have been shown recently, but there is no data on efficacy in long term management of atopic hand dermatitis. This study aims to investigate the efficacy of pimecrolimus 1% cream as maintenance therapy in patients suffering from atopic hand dermatitis. A double-blind vehicle controlled study in 40 adult patients with atopic hand dermatitis (IGA ≤ 3) comparing the efficacy of twice daily application of pimecrolimus 1% cream given as maintenance treatment versus vehicle over a 8 week period after clinical response (IGA ≤ 2) to a 1-3 week pre-treatment with mometasone fuorate 0.1% was performed. Primary endpoint was the time to relapse (IGA ≥ 3). Thirty-six out of 40 patients were randomised to receive either pimecrolimus 1% (P) or vehicle cream (V). The number of patients with stable remission in patients randomised to pimecrolimus (53.8%) and vehicle (43.8%) did not achieve statistical significance between the groups (p = 0.41). Subgroup analysis of patients with initially moderate dermatitis (IGA = 3, n = 20) showed a trend towards a better outcome for the pimecrolimus group (stable remission P = 81.8% versus V = 55.6%) (p = 0.244). Pimecrolimus 1% cream twice daily was not superior to vehicle in the sequential maintenance therapy of atopic hand dermatitis, but efficacy in moderate forms should be investigated in further studies.

The comparison of treatment with clobetasol propionate 0.05% and topical pimecrolimus 1% treatment in the treatment of alopecia areata

Background: Alopecia areata (AA) is a non-scarring hair loss. Objective: We aimed the comparison of clobetasol propionate and pimecrolimus efficiency and tolerability in the treatment of AA. Methods: The study included a total of 100 consecutive patients with AA. Patients were randomized into four groups. 30 patients used 1% pimecrolimus cream, 30 patients used 0.05% clobetasol propionate cream, 20 patients used petrolatum as placebo. Scalp of 20 patients was divided into two equal areas and one area was treated with 1% pimecrolimus cream and the other area with 0.05% clobetasol propionate cream. Results: At week 12 of treatment, the recovery rate of the pimecrolimus group was 53.73 ± 44.49 and the recovery score was 3.63 ± 2.07; that of the clobetasol propionate group was 47.00 ± 44.80 and the recovery score was 3.33 ± 2.20; that of the placebo group was 35.50 ± 40.53 and the recovery score was 2.75 ± 1.88. There was no statistically significant difference among the groups in terms of the percentage of recovery and the recovery score (p < 0.05). Conclusion: In conclusion, we detected that topical pimecrolimus treatment is as effective as topical corticosteroids and is superior to topical corticosteroids in terms of side effects in the treatment of AA.

The Treatment of Vulvar Lichen Sclerosus and Female Sexual Dysfunction

Women with lichen sclerosus (LS) are more likely to have dyspareunia, decreased orgasm, and decreased coital frequency as compared to unaffected women. It is unknown whether standard medical therapy to treat LS results in improved sexual functioning. To describe sexual function in women with LS and to assess if LS-associated sexual dysfunction decreases after appropriate medical therapy. Women enrolled in a double-blind trial 12-week trial comparing clobetasol vs. pimecrolimus for the treatment of LS were administered the Female Sexual Distress Scale (FSDS) upon enrollment and at the end of the trial. The difference in the total score on the FSDS between the two groups before and after treatment was assessed with a paired t-test. The change in mean FSDS score from baseline to 12 weeks. A total of 31 out of 36 enrolled women had adequate treatment of LS as determined by a dermatopathologist's evaluation of pre and post-treatment biopsy specimens. The mean baseline FSDS score for the clobetasol group was 29 and, post-treatment, it was 15 (P=0.001). In the pimecrolimus group, the mean baseline FSDS score was 27 and, post-treatment, it was 21 (P=0.001). Despite adequate treatment, women with LS continue to have significant sexual dysfunction as assessed by the FSDS.

Efficacy and Safety of Pimecrolimus Cream 1% in Mild-to-Moderate Chronic Hand Dermatitis: A Randomized, Double-Blind Trial

Background: Chronic hand dermatitis is common and difficult to treat. Objective: Our aim was to assess the efficacy of pimecrolimus cream 1% in mild-to-moderate chronic hand dermatitis. Methods: Adult patients (n = 652) were randomized to pimecrolimus 1% or vehicle cream twice daily with overnight occlusion for 6 weeks, followed by a 6-week open-label pimecrolimus treatment. Primary efficacy was 5-point Investigators’ Global Assessment of prospectively selected ‘target hand’ as treatment success (Investigators’ Global Assessment 0 or 1) and treatment failure. Pruritus relief was also assessed. Results: Following double-blind phase treatment, target hand treatment success was achieved in 29.8 and 23.2% of the patients in the pimecrolimus and vehicle groups, respectively (p = 0.057). The proportion of patients experiencing pruritus relief was significantly higher in the pimecrolimus group compared to the vehicle group at all time points throughout the double-blind phase. Conclusion: The groups were comparable with respect to treating disease signs. Pruritus relief, however, was significantly greater in the pimecrolimus group.

Pimecrolimus versus placebo in genital aphthous ulcers of Behcet’s disease: a randomized double-blind controlled trial

Genital aphthous ulcers of Behcet's disease (BD) are painful and usually resistant to local treatments. Pimecrolimus is an ascomycin macrolactam, used in inflammatory skin diseases. To discover if pimecrolimus can accelerate the healing of BD genital aphthous ulcers. Ninety patients with genital aphthous ulcers were enrolled. Only patients treated with colchicine alone were selected. All patients signed a written consent form. Patients were randomly assigned to pimecrolimus or placebo cream, applied twice daily for 1 week. The primary outcome was the healing period. Up to 7 days, it was considered as a positive result. Results were compared by chi-square test. The mean healing time was compared by analysis of variance. Analyses were done both by the 'intention-to-treat' and 'treatment-completed' methods. Both groups were similar at the entry (gender, age, ulcer size, pain intensity and treatment delay). By intention-to-treat analysis, in the pimecrolimus group, 18 patients had positive and 27 negative results. In the control group, four had positive and 41 negative results. The difference was significant (chi(2) = 10.167, P = 0.001). By treatment-completed analysis, with pimecrolimus, 18 patients had positive and 22 negative results. With placebo, four had positive, and 41 negative results. The difference was significant (chi(2) = 12.574, P = 0.0004). Comparison of mean healing time in the pimecrolimus versus placebo group, demonstrated a significant acceleration both in intention-to-treat analysis (10.7 vs. 20.7 days, F = 17.466, P < 0.0001) and treatment-completed analysis (8.3 vs. 20.7 days, F = 29.289, P < 0.0001). Pimecrolimus is safe and efficient in the treatment of BD genital ulcers, by accelerating the healing process.

Mometasone cream versus pimecrolimus cream for the treatment of childhood localized vitiligo

Background: With regard to the lack of effective treatment modalities for childhood localized vitiligo, the search for newer therapeutic agents continues.Objective: To conduct an open, comparative trial to evaluate the clinical efficacy and safety of topical mometasone cream and pimecrolimus cream in the treatment of childhood vitiligo.Methods: Fifty patients with childhood vitiligo were included in the study. Patients were treated for 3 months either with mometasone cream (0.1%) once daily or with pimecrolimus cream (1%) twice daily.Results: Forty patients, 20 from each group, completed the study. The two drugs were found to be statistically significantly effective for diminishing lesion size (Z = 3.070,p = 0.002 andZ = 3.845,p < 0.001, respectively). There were no statistical differences between the two drugs:Z = 1.427,p = 0.154 (mometasone non-inferiority to pimecrolimus). The mean repigmentation rate was 65% in the mometasone group and 42% in the pimecrolimus group at the end of therapy. Atrophy, telangiectasia and erythema were observed in two patients (10%) in the mometasone cream group and a burning sensation and pruritus were observed in two patients (10%) in the pimecrolimus cream group; drop-out was not related to the observed adverse effects.Conclusion: Mometasone cream was found to be effective in the treatment of vitiligo on any part of the body. Pimecrolimus was not effective on the body except for the face in childhood localized vitiligo.

Use of pimecrolimus to prevent epidural fibrosis in a postlaminectomy rat model

Epidural fibrosis is the scar tissue formed over the dura mater after a laminectomy. Extensive epidural fibrosis may be an important underlying cause of failed back syndrome. Pimecrolimus, an ascomycin derivative, is one of the new classes of immunomodulating macrolactams and was specifically developed for the treatment of inflammatory diseases. This study examined the preventive effects of the local application of pimecrolimus in minimizing spinal epidural fibrosis in a rat laminectomy model. Thirty Wistar rats were divided into 3 equal groups: control, mitomycin C (MMC), and pimecrolimus groups. Each rat underwent a laminectomy at the L-3 lumbar level. In the experimental groups, a cotton pad soaked with MMC (0.5 mg/ml) or 5 mg pimecrolimus was placed on the exposed dura mater. No treatment was performed in the control group rats. Thirty days after surgery, the rats were killed and the dura mater thickness, epidural fibrosis, and arachnoidal involvement were quantified. The mean dura thickness was measured at 9.28 +/- 3.39 microm in the MMC group and at 8.69 +/- 2.32 microm in the pimecrolimus group, compared with 14.70 +/- 4.14 microm in the control group. In addition, the epidural fibrosis and arachnoidal involvement were reduced significantly in the treatment groups compared with the control group. In this animal model, it was shown that locally applied pimecrolimus effectively reduces epidural fibrosis and dural adherence in rats that underwent lumbar laminectomy. Mitomycin C was equally effective as pimecrolimus in reducing epidural fibrosis and dural adherence in this study.

An open, randomized, prospective, comparative study of topical pimecrolimus 1% cream and topical ketoconazole 2% cream in the treatment of seborrheic dermatitis

Background: 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. Objective: To compare the efficacy and tolerability of pimecrolimus in comparison with ketoconazole in the treatment of SD. Methods: 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. Results: 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. Conclusion: 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.