Total Sign Score Research Articles

Molecular signatures order the potency of topically applied anti-inflammatory drugs in patients with atopic dermatitis

Atopic dermatitis (AD) presents a large unmet need for treatments with better safety and efficacy. To facilitate development of topical therapeutics, we need an efficient model for assessing different formulations and concentrations. The "plaque model" has been successfully implemented in patients with psoriasis, another common inflammatory disease, to assess the efficacy of topical treatments. This model has not been validated for AD, which has higher placebo responses and less stable lesions than psoriasis. We aimed to assess changes in molecular signatures of intrapatient target lesions treated with topical therapeutics. We enrolled 30 patients with mild-to-moderate AD in a randomized, double-blind, intraindividual comparison of 3 approved agents applied blindly at the investigator site daily for 14days: pimecrolimus, betamethasone dipropionate, clobetasol propionate, and a vehicle/emollient control. Changes in total sign scores (TSSs), transepidermal water loss, and tissue biomarkers (determined by using RT-PCR and immunohistochemistry) were evaluated. TSSs showed improvements of 30%, 40%, 68%, and 76% at 2weeks with vehicle, pimecrolimus, betamethasone, and clobetasol, respectively, with parallel changes in transepidermal water loss (P<.05). Significant differences versus vehicle values were limited to steroids (P<.0001). Steroids (particularly clobetasol) restored epidermal hyperplasia and terminal differentiation versus minimal changes with vehicle or pimecrolimus (P<.001). Levels of cellular infiltrates and cytokines (IL-13, IL-22, and S100As) were similarly reduced only by steroids (P<.001). TSS improvement correlated with changes in hyperplasia, infiltrates, and differentiation markers. We detected significant clinical and tissue differences between agents, providing a novel approach to study the differential effects of topical formulations using a limited sample size.

Compound polymyxin B ointment combined with desonide cream for the treatment of subacute or chronic eczema: a multicenter, randomized, double-blind, parallel-group, controlled clinical study

Objective To evaluate the clinical efficacy and safety of compound polymyxin B ointment combined with desonide cream for the treatment of subacute or chronic eczema. Methods A multicenter, randomized, double-blind, parallel-group, controlled clinical study was conducted. Totally, 144 patients with subacute eczema and 144 patients with chronic eczema were enrolled into this study, and both randomly and equally divided into the test group and control group. The test group and control group firstly topically applied compound polymyxin B ointment and its vehicle respectively, then both topically applied desonide cream 3 hours later. The drugs or vehicle were applied twice a day in all the patients. Patients′ symptoms and signs(including degree of itching, inflammation, erosion/exudation and infiltration/thickening, as well as area of target lesions)were evaluated, and the time to onset and duration of itching-alleviating effect were recorded. The clinical efficacy and safety of treatments were analyzed and compared between the test group and control group. Results The total symptom and sign scores significantly decreased to different extents on days 7 and 14 in the test group(subacute eczema patients: 6.09 ± 2.78 and 3.68 ± 3.18 vs. 13.44 ± 1.66; chronic eczema patients: 6.56 ± 2.68 and 4.38 ± 3.27 vs. 12.96 ± 1.16)and control group(subacute eczema patients: 8.26 ± 3.17 and 5.28 ± 4.05 vs. 13.60 ± 1.75; chronic eczema patients: 8.84 ± 2.90 and 6.25 ± 3.78 and vs. 12.64 ± 1.18)compared with those at baseline. Moreover, the total symptom and sign score of patients with subacute or chronic eczema was significantly lower in the test group than in the control group on days 7 and 14(all P < 0.05). A significant increment was observed in the degree of decrease in scores for itch, infiltration/thickening in patients with subacute eczema in the test group compared with that in the control group(all P < 0.01), as well as in scores for itch, infiltration/thickening and area of target lesions in patients with chronic eczema in the test group compared with those in the control group(all P < 0.05). In addition, patients with subacute eczema in the test group showed significantly shorter onset and longer duration of itching-alleviating effect than those in the control group(both P < 0.05). The time to onset of itching-alleviating effect was also significantly shorter in patients with chronic eczema in the test group than in those in the control group(P < 0.000 1), but there was no significant difference in the duration of it between the two groups of patients with chronic eczema. Clinicians and patients were both more satisfied with therapeutic effects in the test group than in the control group(all P < 0.05). Conclusions Topical compound polymyxin B ointment can increase the efficacy of topical desonide cream for the treatment of subacute or chronic eczema, especially subacute eczema. Compound polymyxin B ointment also shows a favorable therapeutic effect on itching and infiltration/thickening in patients with eczema. Key words: Eczema; Polymyxin B; Desonide; Randomized controlled trial

Effect of yangxinkang tablets on chronic heart failure: A multi-center randomized double-blind placebo-controlled trial.

To investigate the safety and efficacy of yangxinkang tablets in patients with chronic heart failure (CHF) and syndrome of qi and yin deficiency, blood stasis, and water retention. In a double-blinded, randomized, placebo-controlled, multicenter clinical trail, 228 patients with CHF New York Heart Association (NYHA) class II or III in stage C were assigned by randomized block method to two groups in a 1:1 ratio to undergo either conventional Western treatment or conventional treatment plus yangxinkang tablets for 4 weeks. The outcome measure were effect of cardiac function, Chinese medicine (CM) syndromes, scores of symptoms, signs, and quality of life measured by Minnesota Living with heart failure questionnaire (MLHFQ) before and after the treatment. Totally 112 patients were analyzed in the treatment group and 109 in the control group. They were comparable in NYHA functional class, basic parameters and primary diseases before treatment. Cardiac function and CM syndromes were greatly ameliorated in both groups after treatment. Total effective rates of cardiac function and CM syndrome in the treatment group were significantly higher than those in the control group (P<0.05). Total symptom score and sign score in the treatment group decreased significantly after treatment (P<0.01), which were significantly lower than those in the control group (P<0.05). There were statistically significant differences in post-treatment scores of gasp, cough with phlegm, pulmonary rales and jugular vein engorgement between the two groups (P<0.05 or P<0.01). Three MLHFQ scores decreased significantly in both groups after treatment (P<0.01). Post-treatment total scale score and physical subscale score in the treatment group and the reduction of them showed statistically significant differences (P<0.05) as compared with the control group. There was no significant difference between the two groups in emotional subscale score and the reduction after treatment (P>0.05). There was no obvious adverse reaction in either group noted during the study. Yangxinkang tablets were safe and efficacious in improving cardiac function, CM syndromes, symptoms, signs, and quality of life in patients with CHF class II or III in stage C on the base of conventional treatment.

Efficacies and safety of traditional Chinese medicine plus bifonazole cream for tinea pedis patients

To evaluate the efficacy and safety of traditional Chinese medicine plus bifonazole 1% cream in the treatment of tinea pedis. A total of 375 patients with tinea pedis were randomly assigned to receive traditional Chinese medicine plus bifonazole 1% cream (treatment group, n=196) or bifonazole 1% cream alone (control group, n=179). Efficacy was estimated in terms of mycological care, total clinical sign and symptom scores. And adverse reactions were also recorded. The results showed that, at Week 2 post-treatment, the cure rate was 45.41% (89/196) and effective rate 77.04% (151/196) in combination group versus 34.08% (61/179) and 61.45% (110/179) in control group. There was significant inter-group difference (P 0.05). Key words: Tinea, foot; Treatment outcome

The Leptomeningeal Ivy Sign on Fluid-Attenuated Inversion Recovery Images in Moyamoya Disease: Positron Emission Tomography Study

Background: The ivy sign is sometimes seen on fluid-attenuated inversion recovery (FLAIR) images in moyamoya disease (MMD). In recent studies using single-photon emission computed tomography, ivy sign proliferation correlated with decreases in cerebrovascular reserve. However, a decreased vascular reserve is not concrete. The purpose of this study was to evaluate the correlation between ivy sign proliferation and the findings of ¹⁵O gas positron emission tomography (PET). Methods: In 19 MMD patients (12 women, age 31-69 years) with ischemic symptoms, FLAIR magnetic resonance imaging and ¹⁵O gas PET were performed. We classified the middle cerebral artery (MCA) territory into 2 regions in each hemisphere, and the degree of the ivy sign (ivy sign score) in each region was classified into 3 grades (0-2), where grade 0 indicated an absence of the ivy sign, grade 1 indicated that the ivy sign was seen on less than half of the cortical surface in each region, and grade 2 indicated that the ivy sign was seen on more than half of the cortical surface. We examined the relationship among the ivy sign score, the severity of ischemic symptoms and PET parameters in 76 MCA regions of 19 patients. Results: Ivy sign scores of the regions were 0 (n = 19), 1 (n = 40), and 2 (n = 17). Total ivy sign score of a hemisphere increased as clinical symptoms became more severe. Cerebral blood flow (CBF) values were lower, cerebral blood volume (CBV) values were higher, and CBF/CBV values were lower than those of controls as symptoms became severe (p < 0.05). CBF and CBF/CBV values decreased and CBV values increased as the ivy sign score increased, and were significantly higher and lower, respectively, than control values (p < 0.05). No significant differences in cerebral metabolic rate of oxygen and oxygen extraction fraction were found between the 3 ivy sign scores. A positive correlation was found between ivy sign score and increases in CBV (p < 0.01), and a more obvious negative correlation was found between ivy sign score and decreases in CBF/CBV (p < 0.001). Conclusions: We evaluated the correlation between ivy sign proliferation and the findings of ¹⁵O gas PET. We suggested that ivy sign proliferation was associated with both dilated pial vasculature and the slow flow of developed leptomeningeal collaterals in patients with MMD.

A Novel Formulation of Mometasone Furoate in Psoriasis Patients: A Multicenter, Randomized, Double-Blind Clinical Study

Further formulations of mometasone furoate are needed for treatment of patients with plaque psoriasis to meet individual patient preferences. This has motivated the development of Ovixan(®) (Galencia, Malmoe, Sweden), a formulation of mometasone furoate with different cosmetic properties than the commonly used formulation, Elocon(®) (Merck [Schering Plough], Whitehouse Station, New Jersey, USA). This novel formulation of mometasone furoate was examined in a vasoconstrictor assay comparing its efficacy with that of Elocon. Subsequently, the new formulation was tested in a multicenter, randomized, double-blind clinical study in patients with plaque psoriasis. Healthy volunteers were included in the vasoconstrictor study. The treatments were randomly assigned to test fields on the forearms. The test fields were gently cleaned after treatment for 6 h. Skin color was measured during the following 24 h and area under the time curve was calculated. The clinical efficacy and tolerance of Ovixan was as compared to that of Elocon and their vehicles in a double-blind study in patients with plaque psoriasis. Patients with four symmetrically placed lesions on the arms or the legs were treated for 6 weeks. Primary endpoint was the change from baseline of the Total Severity Sign score for each treated lesion. The cosmetic characteristics of the two test preparations were assessed by an independent cosmetological institute. Ovixan was shown to have skin blanching potency almost identical to the vasoconstrictor potency of Elocon. Clinical equivalence of Ovixan to Elocon was demonstrated in the clinical study of the efficacy in patients with plaque psoriasis. A professional testing team clearly documented the cosmetic superiority of Ovixan as compared to Elocon. The results of the investigations show that Ovixan is equipotent to the commonly used formulation Elocon. However, the cosmetic properties are in favor of Ovixan. The effect of the cosmetic differences on patient preferences and patient adherence to prescribed treatment has to be investigated in further studies.

Prevalence and Severity of Blepharitis Symptoms and Signs amongst Patients with Age-Related Macular Degeneration

Purpose: It is recommended that prior to intravitreal injections, ophthalmologists identify and treat comorbidities that predispose a patient to endophthalmitis,. Therefore, in populations that frequently receive intravitreal injections, such as patients with age-related macular degeneration (AMD), it is important to know the prevalence of these comorbidities. Blepharitis is a disease that is known to predispose to endophthalmitis, however, little is known on the rates of blepharitis within the AMD patient population. The purpose of this study was to determine the prevalence and severity of blepharitis amongst patients with age-related macular degeneration (AMD). Methods: This IRB approved study included 50 patients (21 male, 29 female, age 78.1 ± 8.48 years) with both dry (n=21) and wet (n=29) AMD. Five common ocular surface symptoms and four clinical signs associated with blepharitis were evaluated. They were scored (0-4) by a self-reported survey and a blinded investigator performing a clinical examination. To compare the prevalence and severity of the symptoms and signs, total symptom and total sign scores were calculated and then normalized to the same scale of 0-10. The severity of symptoms and signs were then categorized as normal (0), mild (0.1-3.3), moderate (3.4-6.6), severe (6.7-10). Results: In this AMD patient population, 32% had a history of dry eye or blepharitis prior to examination and 26% had a history of rosacae. Self-reported patient surveys and blind investigator examinations both demonstrated similar high prevalence of blepharitis. 14%of total patients reported no symptoms, and 6% had no clinical signs of blepharitis. Most patients had mild to moderate disease. The incidences were 50% and 36% for mild grade, 32% and 50% for moderate grade, and only 4% and 8% for severe grade, for the symptoms and signs of blepharitis, respectively. Self reported symptom scores were generally lower than clinical examination scores. Conclusions: Both the rate and severity of signs and symptoms of blepharitis are increased in the AMD patient population. Implications of these finding should be further studied in a larger series to determine its impact on endophthalmitis occurrence.

A calcipotriene/betamethasone dipropionate two‐compound scalp formulation in the treatment of scalp psoriasis in Hispanic/Latino and Black/African American patients: results of the randomized, 8‐week, double‐blind phase of a clinical trial

The calcipotriene/betamethasone dipropionate two-compound scalp formulation has been shown to be safe and effective in the treatment of scalp psoriasis over 8 weeks, but the patients studied were mainly White and non-Hispanic. The aim of this study was to evaluate the efficacy and safety of the two-compound scalp formulation in the treatment of scalp psoriasis in Hispanic/Latino and Black/African American patients. A total of 99 Hispanic/Latino and 78 Black/African American patients were randomized double-blind in a 3:1 ratio to 8 weeks of once daily treatment of scalp psoriasis with either the two-compound scalp formulation (n=135) or its vehicle (n=42). In the two-compound group, 71.9% of patients had cleared or minimal disease at week 8 by the investigator's global assessment compared to 40.5% in the vehicle group (odds ratio 3.30; 95% CI 1.62-6.72; P<0.001). For the five secondary efficacy response criteria, three (total sign score, thickness of scalp psoriasis, patient's global assessment) showed that two-compound scalp formulation was statistically significantly more effective than its vehicle, and the other two (redness and scaliness of scalp psoriasis) approached statistical significance in favor of the two-compound scalp formulation. There was no statistically significant difference (P=1.00) between the percentage of patients with adverse reactions in the two-compound group (7.0%) and the vehicle group (7.9%). The two-compound scalp formulation is safe and effective in the treatment of scalp psoriasis over 8 weeks in Hispanic/Latino and Black/African American patients.

In Vivo Characterization of Doxycycline Effects on Tear Metalloproteinases in Patients with Chronic Blepharitis

Matrix metalloproteinases (MMPs) have a role in the pathogenesis of rosacea-associated chronic blepharitis. Doxycycline is largely used as a treatment for recalcitrant chronic blepharitis. It has been shown in vitro that doxycycline inhibits MMPs activation. The aim of this study was to investigate in vivo the effect of doxycycline in modulating MMPs in patients with chronic idiopathic blepharitis. Eight patients (6 male, 2 female; mean age 45.7+/-17.5 years) were included in the study. Doxycycline (100 mg) was administered orally, twice a day, for 2 weeks and once a day for an additional 2 weeks. Clinical signs and symptoms were evaluated and scored (0-3) at baseline and after 4 weeks. Total sign (TSS) and total symptom (TSyS) scores were calculated. Tear samples and conjunctival impression cytologies were collected at baseline and after 4 weeks of treatment to evaluate MMP-9 and TIMP-1 expression and activity. An improvement in TSS (4.5+/-1.1 vs 2.7+/-1.5) and TSyS (6.6+/-1.3 vs. 3.1+/-1.9) was observed after 4 weeks, with significant amelioration of hyperemia, marginal blepharitis, and superficial punctuate keratopathy. Zymography revealed a decrease of MMP-9 activity after 4 weeks. MMP-9 mRNA and protein levels did not change, while an upregulation of TIMP-1 expression was observed. This study suggests that 4-week treatment with doxycycline significantly improved symptoms and signs in patients with chronic blepharitis in association with a decrease in MMP-9 activity. Upregulation of TIMP-1 is proposed as a possible mechanism of MMP-9 inactivation.

A Large Prospective Observational Study of Novel Cyclosporine 0.1% Aqueous Ophthalmic Solution in the Treatment of Severe Allergic Conjunctivitis

To evaluate the effectiveness and safety of a novel cyclosporine 0.1% aqueous ophthalmic solution in a large population with vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC). A prospective observational postmarketing study was initiated in Japan. A total of 594 patients with VKC or AKC were started on this drug within 1 year after market launch (January 2006) and completed a 6-month follow-up. These patients were observed clinically, and subjective ocular symptoms (itching, discharge, tearing, photophobia, foreign body sensation, and pain), objective signs (hyperemia, swelling, follicle, papillae, and giant papillae for the tarsal conjunctiva; hyperemia and edema for the bulbar conjunctiva; Trantas dots and swelling for the limbus; and corneal involvement), and adverse events were recorded. All scores for symptoms and signs significantly decreased from Month 1 through Month 6 of treatment in both VKC and AKC. Median total symptom scores at baseline, Month 1, and Month 6 were 6, 2, and 1, respectively, for VKC, and 7, 3, and 2, respectively, for AKC. Similarly, median total sign scores were 12, 7, and 5, respectively, for VKC, and 14, 10, and 7, respectively, for AKC. The percentage of patients able to complete topical cyclosporine 0.1% therapy within 6 months due to alleviation of symptoms was higher for VKC (44.4%) than for AKC (21.9%). In both VKC and AKC, approximately 30% of steroid users were able to discontinue topical steroids. Adverse drug reactions (ADRs) were found in 12.0% of patients, and the most common ADR was eye irritation (4.4%). Infectious corneal complications were observed in five AKC patients, including two cases of bacterial corneal ulcer and three cases of herpetic keratitis; all of these patients were concomitantly using topical steroids. Topical cyclosporine 0.1% is an effective and safe treatment for VKC and AKC.

Calcipotriol plus Betamethasone Dipropionate Scalp Formulation Is Effective and Well Tolerated in the Treatment of Scalp Psoriasis: A Phase II Study

Background: There is a need for more effective therapy for scalp psoriasis. Objective: To assess the efficacy and safety of a 2-compound scalp formulation including calcipotriol and betamethasone dipropionate in the treatment of scalp psoriasis. Methods: Patients (n = 218) with scalp psoriasis were randomized to treatment with the 2-compound scalp formulation (n = 108) or betamethasone dipropionate in the same vehicle (n = 110). The treatments were applied once daily on the scalp for up to 8 weeks. Results: The 2-compound scalp formulation showed a significantly higher efficacy than betamethasone dipropionate on the total sign score at the end of treatment (p = 0.042) and after 2 weeks (p = 0.005). Conclusion: The calcipotriol plus betamethasone dipropionate scalp formulation was superior to betamethasone dipropionate in the same vehicle when used once daily for up to 8 weeks in the treatment of scalp psoriasis.

Preliminary evidence of the efficacy of probiotic eye-drop treatment in patients with vernal keratoconjunctivitis

Probiotics have been shown to improve allergic inflammation. The aim of this study was to evaluate the efficacy of Lactobacillus Acidophilus eye-drops in controlling signs and symptoms of vernal keratoconjunctivitis (VKC). Seven patients (mean age 11.8 +/- 4.3; five M, two F) with mild to moderate VKC were included in the study. Lactobacillus Acidophilus diluted in saline solution (2 x 10(8) CFU/ml) was administrated as eye-drops four times daily for 4 weeks in both eyes. Clinical signs (conjunctival hyperemia, chemosis, secretion, Trantas dots, superficial punctuate keratitis) and symptoms (itching, photophobia, burning, tearing) were evaluated and scored from 0 to 3 at baseline, after 2 and 4 weeks of treatment. Total sign (TSS) and symptom (TSyS) scores were calculated. Conjunctival impression cytology was performed in three patients at baseline and after 4 weeks of treatment, in order to evaluate the expression of ICAM-1 and TLR-4. In the six out of seven patients who completed the study, symptoms were significantly improved after both 2 weeks (TSyS: baseline 6.7 +/- 0.9 vs 4.1 +/- 1.2; p = 0.017) and 4 weeks (TSyS: baseline 6.7 +/- 0.9 vs 3.6 +/- 1.2, p = 0.011) of treatment. A significant improvement of clinical signs was observed after 4 weeks of treatment (TSS: baseline 7.5 +/- 1.6 vs 3.9 +/- 1.7, p = 0.034) but not after 2 weeks of treatment (TSS: baseline 7.5 +/- 1.6 vs 5.3 +/- 1.5; NS). In particular, photophobia was significantly reduced (2 +/- 0.6 vs 1 +/- 0.3; p = 0.023) at 2 weeks, while at 4 weeks the scores for itching (1.8 +/- 0.3 vs 1 +/- 0.3), tearing (1.6 +/- 0.4 vs 0.8 +/- 0.2), conjunctival hyperemia (2.3 +/- 0.2 vs 1.4 +/- 0.5) and chemosis (1.2 +/- 0.4 vs 0.4 +/- 0.4) were significantly lower compared to baseline. A down-regulation of ICAM-1 and TLR-4 was observed in two patients showing clinical improvement after 4 weeks of treatment. Our open pilot study showed that 1-month treatment with probiotic eye-drops improves signs and symptoms in patients with VKC. Additional double-blind controlled clinical trials with a larger sample of patients are needed to confirm the effects of topical Lactobacilli on VKC patients.

Development and Testing of the Quality of Life in Children with Vernal Keratoconjunctivitis Questionnaire

To develop and validate a questionnaire that measures health-related quality of life (HRQoL) in children with vernal keratoconjunctivitis (VKC). Prospective, observational case series. An initial list of 42 items was developed and administered to 30 children with active VKC (six girls and 24 boys; mean age, nine +/- two years). The 30 most significant items were selected and converted into questions on a three-step scale for validation in 41 children with active VKC (eight girls and 33 boys; mean age, 9.5 +/- 2.1 years). Twenty-two children also completed the generic KINDL questionnaire. Clinical signs were evaluated and scored and total sign scores (TSSs) were calculated. Validation was performed by factorial analysis and Pearson correlation. Internal consistency was computed by the Chronbach alpha on the extracted factors. Factorial analysis extracted two factors with good internal consistency: symptoms (12 items; alpha = 0.89) and daily activities (four items; alpha = 0.77). Correlations of Quality of Life in Children with Vernal Keratoconjunctivitis (QUICK) scores to KINDL scores were in the expected direction. Most patients reported itching (93%), burning (90%), redness (90%), the need to use eye drops (90%), tearing (83%), and photophobia (80%). The children's greatest concerns were limitations on going to the pool (71%), playing sports (58%), and meeting friends (58%). QUICK symptom scores were correlated significantly to conjunctival hyperemia (P < .001), secretion (P = .042), chemosis (P = .012), superficial punctate keratopathy (P < .001), and TSS (P = .010). The QUICK questionnaire is a new, simple instrument to measure HRQoL in children with severe allergic conjunctivitis. This test is effective for the global evaluation of the impact of VKC on children's daily lives.

Upregulation of ICAM-1 Expression in the Conjunctiva of Patients with Chronic Graft-Versus-Host Disease

To correlate conjunctival intercellular adhesion molecule 1 (ICAM-1) expression with cytologic and clinical findings of chronic graft-versus-host disease (GVHD). Seven patients with chronic GVHD-related keratoconjunctivitis and five age-matched normal controls were recruited for the study. Clinical examination included medical history, visual acuity, evaluation of ocular signs and symptoms (scored from 0 to 3), corneal fluorescein staining (scored from 0 to 5 on the basis of the number of corneal sectors involved), Schirmer test type I, and break-up time (BUT). Impression cytology samples were collected from the nasal and inferior bulbar conjunctiva of patients and controls. Goblet cells were counted in three randomly selected fields and averaged. Immunofluorescent staining for ICAM-1 was carried out and the percentage of cells expressing the marker was evaluated. All patients showed signs and symptoms of keratoconjunctivitis sicca. Schirmer test type I and BUT were reduced (4.8+/-6.7 mm/5 min and 3.9+/-2.7 seconds, respectively). Goblet cells were significantly reduced in GVHD eyes with respect to normal eyes (65+/-30.5 and 192+/-16.9 cells/field respectively; p<0.001). Goblet cell number was directly related to Schirmer test values (p<0.01, rho=0.817) and inversely related to total sign score (p<0.01, rho=-0.939). ICAM-1 expression was increased in GVHD eyes with respect to normal controls, in which no staining was observed. ICAM-1 expression showed an inverse relation to goblet cell number (p<0.01, rho=-0.852) and Schirmer test values (p<0.01, rho=-0.926), and was directly correlated to total sign score (p<0.01, rho=0.982). Conjunctival ICAM-1 expression is increased in GVHD patients. The severity of the disease is associated with tear parameters, goblet cell decrease, and inflammatory markers, such as ICAM-1.

Double‐blind, randomised, multicentre, parallel group study comparing a 1% coal tar preparation (Exorex) with a 5% coal tar preparation (Alphosyl) in chronic plaque psoriasis

BACKGROUND: Exorex lotion is a novel formulation of prepared coal tar indicated for the treatment of psoriasis.OBJECTIVES: To compare the efficacy and tolerability of 1% prepared coal tar lotion versus 5% coal tar extract in patients with mild to moderate plaque psoriasis.PATIENTS AND METHODS: This was a double‐blind, randomised controlled study. Patients initially entered a 7‐day washout period, during which they applied a yellow soft paraffin plus emulsifying wax ointment used as an emollient three times a day to their plaques. They were then randomised to receive treatment with 1% coal tar (Exorex) lotion or 5% conventional coal tar lotion (Alphosyl), three times a day for 12 weeks. Both treatment groups continued to apply the emollient throughout the duration of the study. Two target plaques were selected at entry for assessment. The clinical measures used were: 1) Total Sign Score (TSS), the sum of 5‐point rating scores for erythema, induration and scaling averaged for the two target plaques (range 0–12), 2) the Psoriasis Area and Severity Index (PASI), and 3) patient and investigator 7‐point global assessments of improvement at 12 weeks. Patients were assessed at 0, 4, 8 and 12 weeks during the treatment period or at the point of withdrawal. Spontaneously reported and observed adverse events were noted.RESULTS: Three hundred and twenty four of 338 randomised patients were evaluable (ITT analysis): 158 patients received 1% coal tar lotion and 166 patients received conventional coal tar. Both groups showed decreases from baseline to end of treatment in mean TSS (decrease of 2.4 points from 5.6 to 3.2 with 1% coal tar lotion and 1.8 points from 5.5 to 3.7 with conventional coal tar), and mean PASI (decrease of 2.4 points with 1% coal tar lotion and 1.5 points with conventional coal tar). Two hundred and twenty eight patients completed the full course of treatment. There was a statistically significant treatment difference in the percentage change in mean TSS at week 12, in favour of 1% coal tar lotion (‐10.6%, 95% CI ‐20.6% to ‐0.5%, p=0.04). There was also a difference between treatments in the change in mean PASI in favour of 1% coal tar that was of borderline statistical significance (‐11.7%, 95% CI ‐23.8% to 0.4%, p=0.06). Investigator global assessments also favoured 1% coal tar lotion (38% vs. 27% of patients showed clearance or marked improvement). The 1% coal tar lotion had a similar safety profile to 5% conventional coal tar lotion with the majority of treatment‐related events being mild to moderate in severity.CONCLUSIONS: 1% coal tar lotion is more effective than a conventional coal tar lotion in mild to moderate psoriasis and may be preferred for first‐line topical treatment.

Efficacy and tolerability of borage oil in adults and children with atopic eczema: randomised, double blind, placebo controlled, parallel group trial

Objective To study the efficacy and tolerability of borage oil, which contains a high concentration of γ linolenic acid, in children and adults with atopic eczema.Design Single centre, randomised, double...

Effects of a low-potency corticosteroid lotion plus a moisturizing regimen in the treatment of atopic dermatitis

Treatment goals for atopic dermatitis consist of attempting to eliminate inflammation and infection, hydrating the skin, controlling pruritus, and avoiding exacerbative factors. The aim of this study was to evaluate the effects of adding a moisturizing regimen to a low-potency topical corticosteroid lotion regimen in the treatment of atopic dermatitis. This controlled, randomized, investigator-masked 3-week study was undertaken to compare twice-daily applications of desonide lotion 0.05% alone with twice-daily applications of desonide lotion 0.05% plus three-times-daily applications of a moisturizing cream. The efficacy variables assessed included erythema, dryness or scaling, pruritus, excoriations, lichenification, oozing or crusting, and induration or papules. Administration of desonide lotion alone created statistically significant improvement in total sign and symptom scores. The addition of a moisturizer to the treatment regimen produced additional statistically significant improvement in total sign and symptom scores, physicians' global assessments of improvement, and most of the individual efficacy variables. Results of this study suggest that the addition of a moisturizer to a low-potency corticosteroid lotion in separate regimens was effective in treating the signs and symptoms of mild-to-moderate atopic dermatitis.

Mometasone furoate 0.1%—salicylic acid 5% ointment versus mometasone furoate 0.1% ointment in the treatment of moderate-to-severe psoriasis: a multicenter study

Topical corticosteroids and keratolytics are both used widely in the management of patients with psoriasis. A combination of the two types of agents may provide enhanced relief. The purpose of this study was to compare the efficacy and safety of the combination ointment mometasone furoate 0.1% plus salicyclic acid 5% with that of mometasone furoate 0.1% ointment in the treatment of moderate-to-severe psoriasis vulgaris. A total of 408 patients were enrolled in this controlled, randomized, double-masked, parallel-group, multicenter comparison. Patients applied either mometasone furoate—salicylic acid ointment or mometasone furoate ointment alone to target lesions twice daily for 21 days. Severity of erythema, induration, and scaling were scored at baseline and at days 4, 8, 15, and 22. An evaluation of overall change in disease status of all treated lesions was performed at each follow-up visit. Adverse events were also monitored and scored, including signs of skin atrophy. Beginning on day 8, the combination of mometasone furoate—salicylic acid was significantly more effective than mometasone furoate alone, as indicated by the mean percentage of improvement in total disease scores, mean total disease sign scores, and the individual score for scaling. Similarly, the combination was more effective beginning on day 15, as indicated by the global evaluation of overall clinical response and individual scores for erythema and induration. Both treatments were well tolerated. Mometasone furoate—salicylic acid ointment provides more effective treatment of moderate-to-severe psoriasis than does mometasone furoate ointment alone and is safe and well tolerated.

Mometasone furoate 0.1%—salicylic acid 5% ointment twice daily versus fluocinonide 0.05% ointment twice daily in the management of patients with psoriasis

This study compared the clinical efficacy and safety of the combination agent mometasone furoate 0.1%—salicylic acid 5% ointment with those of the single agent fluocinonide 0.05% ointment, each applied twice daily for 21 days, in the treatment of patients with moderate to severe plaque psoriasis. Forty adult patients were included in this single-center, randomized, double-masked, intraindividual, bilateral-paired comparative trial. Two similar, bilaterally symmetrical target lesions on the trunk, arms, or legs of each patient were selected for treatment and evaluation. One lesion was treated with mometasone furoate 0.1%—salicylic acid 5% ointment, and the other was treated with fluocinonide 0.05% ointment, both twice daily for 21 days. Treatment was randomly assigned to the right or left side of the body. Signs of psoriasis (ie, erythema, induration, and scaling) and overall clinical response were evaluated and scored on days 4, 8, 15, and 22 and compared against baseline. Patients were asked to evaluate the treatments for efficacy and acceptability at each visit. The primary efficacy parameter was the mean percentage of improvement in total sign scores for the target lesions. Safety was evaluated based on clinical observation and patients' reports. Beginning with day 15, statistically significant differences favoring mometasone furoate 0.1%—salicylic acid 5% ointment over fluocinonide 0.05% ointment were seen in individual and total sign scores, as well as in overall global clinical response. On day 15, 20 patients expressed a preference for one treatment over the other, and 20 patients made no distinction between the two. Of those who expressed a preference, significantly more patients believed mometasone furoate 0.1%—salicylic acid 5% ointment to be better than fluocinonide 0.05% ointment. ON day 22, of 25 patients who expressed a preference, significantly more patients thought mometasone furoate 0.1%—salicylic acid 5% ointment was better than fluocinonide 0.05% ointment. No adverse events were recorded for either treatment group. The combination mometasone furoate 0.1%—salicylic acid 5% ointment was significantly more efficacious than and equally as safe as fluocinonide 0.05% ointment in the management of patients with plaque psoriasis and was preferred by a greater number of patients.

Farrowing unit housing and management factors associated with diseases and disease signs of importance for feeder pig quality

Housing and management were described in 114 randomly selected farrowing units. Associations between housing/management factors, enzootic pneumonia, erysipelas and disease signs of importance for feeder pig quality were investigated. Diarrhea, coughing, sneezing, joint infection and mange signs were scored and summed to create a total sign score. Factors increasing the risk of unfavorable outcomes included slatted pen floors, liquid manure management, restricted water, free access of cats and dogs into the piggery, pigs’ admission to dung alley, low relative humidity, creep feed serving on floor, existence of boar(s) in the herd and large herd size. Solid, concrete pen floors, straw bedding, solid manure management, nipple water and quarantine for replacement pigs decreased the risk of unfavorable outcomes.