Efficacy of intra-lesional injections of meglumine antimoniate once a week vs. twice a week in the treatment of cutaneous leishmaniasis caused by L. tropica in Iran: A randomized controlled clinical trial.

Treatment of Cutaneous leishmaniasis (CL) is based on using antimoniate derivatives; patients' compliance for systemic injections is low due to the pain and systemic complications. In this randomized open trial, the efficacy of intra-lesional (IL) injections of meglumine antimoniate (MA) once a week vs. twice a week in the treatment of Anthrpoponothic CL caused by L. tropica was studied. Eligible volunteer patients were selected according to inclusion/exclusion criteria. The included patients were randomly allocated to receive IL-MA injections once a week or twice a week. The primary outcome was set as complete healing of the lesion(s), and defined as complete re-epithelialization and absence of induration in the lesions. A total of 180 parasitologicaly proven CL patients caused by L. tropica were recruited, 90 patients were treated with weekly IL-MA and 90 patients received IL-MA twice a week. The complete cure was 87.9% vs. 89.2% in the group received weekly and twice a week IL-MA injections, respectively (P = 0.808). Patients' compliance was acceptable and side effects were limited to a few local allergic reactions to MA. Median time to healing was significantly shorter in patients who received IL-MA twice a week (median ± SE) 37±3.8, (CI: 29.6-44.4) days compared to whom received IL-MA once a week 60±2.3, (CI: 55.6-64.5) days (P< 0.001), however the number of injections was higher in group who received IL-MA twice a week (12 vs. 9 injections). In conclusion, the rate of cure in the group of CL patients with IL-MA twice a week was not significantly different from the group who received IL-MA once a week shorten, but the duration of healing was shorter in the group who received IL-MA twice a week while the group received more injections so is recommended to use IL-MA once a week due to the fact the compliance is acceptable with limited side effects. Clinical Trial Registration: IRCT20081130001475N13; https://en.irct.ir/.

Associated-risk determinants for anthroponotic cutaneous leishmaniasis treated with meglumine antimoniate: A cohort study in Iran.

BACKGROUND: The control of cutaneous leishmaniasis (CL) is facilitated by knowledge of factors associated with the treatment failures in endemic countries. The aim of this evaluation was to identify the potential risk determinants which might affect the significance of demographic and clinical characteristics for the patients with anthroponotic CL (ACL) and the outcome of meglumine antimoniate (MA) (Glucantime) treatment. METHODOLOGY/PRINCIPAL FINDINGS: This current was executed as a cohort spanning over a period of 5 years which centered in southeastern part of Iran. Altogether, 2,422 participants were evaluated and 1,391 eligible volunteer patients with ACL caused by Leishmania tropica were included. Overall, 1,116 (80.2%) patients received MA intraleisionally (IL), once a week for 12 weeks along with biweekly cryotherapy, while 275 (19.8%) patients received MA alone (20 mg/kg/day for 3 weeks) (intramuscular, IM). The treatment failure rate in ACL patients was 11% using IL combined with cryotherapy plus IM alone, whilst 9% and 18.5% by IL along with cryotherapy or IM alone, respectively. Multivariate logistic regression model predicted 5 major associated-risk determinants including male (odds ratio (OR) = 1.54, confidence interval (CI) = 1.079-2.22, p = 0.018), lesion on face (OR = 1.574, CI = 1.075-2.303, p = 0.02), multiple lesions (OR = 1.446, CI = 1.008-2.075, p = 0.045), poor treatment adherence (OR = 2.041, CI = 1.204-3.46, p = 0.008) and disease duration > 4 months (OR = 2.739, CI = 1.906-3.936, p≤0.001). CONCLUSIONS/SIGNIFICANCE: The present study is the original and largest cohort of ACL patients who treated with MA. A comprehensive intervention and coordinated action by the health authorities and policy-makers are crucial to make sure that patients strictly follow medical instructions. Early detection and effective therapy < 4 months following the onset of the lesion is critical for successful treatment of the patients. Since a significant number of patients are still refractory to MA, reducing man-vector exposure and development of new effective alternative drugs are essential measures against ACL due to L. tropica.

A single-group trial of end-stage patients with anthroponotic cutaneous leishmaniasis: Levamisole in combination with Glucantime in field and laboratory models.

Currently, there is no satisfactory treatment modality available for cutaneous leishmaniasis (CL). The major objective of the present study was to explore the effect of immunomodulator-levamisole in combination with Glucantime in end-stage unresponsive patients with anthroponotic CL (ACL). Twenty end-stage unresponsive patients with ACL were identified for participation in this single-group trial study. Simultaneously, each patient was received a combination of levamisole pills along with Glucantime during the remedy course. Several in vitro complementary experiments were performed to evaluate the mode of action of levamisole and Glucantime alone and in combination using a macrophage model, in vitro MTT assay, flow cytometry and quantitative real time PCR (qPCR). Overall, 75% of the patients showed complete clinical cure, 10% partially improved and the remaining (15%) had underlying chronic diseases demonstrated no response to the treatment regimen. In in vitro studies, there was no cytotoxic effect associated with these drugs in the range of our experiments. The findings by the flow cytometric analysis represented that the highest apoptotic values corresponded to the drugs combination (32.23%) at 200 µg/ml concentration. Finally, the gene expression level of IL-12 p40, iNOS and TNF-α promoted while the level of IL-10 and TGF-ß genes reduced as anticipated. The findings clearly indicated that the combination of levamisole and Glucantime should be considered in end-stage unresponsive patients with ACL who have not responded to basic treatments. The immunomodulatory role of levamisole in mounting immune system as documented by the in vitro experiments and further substantiated by this single-group trail study was highlighted.

Treatment of Atopic Dermatitis From the Perspective of Traditional Persian Medicine: Presentation of a Novel Therapeutic Approach.

There is a strong current trend for using complementary and alternative medications to treat atopic dermatitis. Atopic dermatitis is a common, chronic, pruritic, and inflammatory skin disease. It can have a profound, negative effect on patients' quality of life. Mild cases of atopic dermatitis can be controlled by the application of moisturizers and topical corticosteroids. However, in severe cases, application of immunosuppressive medication is unavoidable but it can have adverse effects. In traditional Persian medicine, diseases similar to resistant atopic dermatitis are treated with whey in combination with decoction of field dodder. Both whey and field dodder have anti-inflammatory properties. Consumption of whey can also aid skin repair, mitigate pruritus, and help combat the high level of stress experienced by patients. Therefore, it is hypothesized that consumption of traditional medicinal treatment of whey with decoction of field dodder can be applied as a complementary treatment for atopic dermatitis.

Clinical Features of Anthroponotic Cutaneous Leishmaniasis in a Major Focus, Southeastern Iran, 1994-2014.

BACKGROUND: Cutaneous leishmaniasis (CL) is associated with a broad and complex clinical spectrum of diseases. The objectives of this study were to assess the clinical features and identification of the causative agents of CL in a well-known focus of anthroponotic CL (ACL) caused by Leishmania tropica, southeast Iran. METHODS: This study was performed randomly as a descriptive cross-sectional survey to evaluate 2000 CL patients by active and passive case-detection approaches in Kerman Province from 1994 to 2014. The ACL patients were confirmed by direct smear and 600 cases by one or a combination of intrinsic methods. RESULTS: Children aged <10 yr old were the most infected patients (P<0.001). The majority of the CL lesions were located in hands (46.3%), face (34.1%), legs (14.3%), and other parts of the body (5.3%). The mean number of lesions was 1.5 and most of the patients had single lesion (65%).Typical clinical lesions included papule (36.8%), followed by ulcerated nodule (20.7%), plaque (18.4%), and ulcerated plaque (18.5%). While among atypical clinical features, leishmaniasis recidivans (LR) (4.7%) and leishmanid (0.3%) were the dominant forms, followed by diffuse, disseminated, sporotrichoid, and erysipeloid types, 0.1% each, and then lymphedematous, lymphadenic, hyperkeratotic, paronychial, and mutilating types, 0.05% each. Based on various intrinsic methods the parasites isolated from the lesions were characterized as L. tropica. CONCLUSION: ACL due to L. tropica presents numerous cases of localized form and diverse uncommon clinical presentations, which mimic other disease conditions. Therefore, physicians should be aware of such manifestations for selecting appropriate treatment modality.

The efficacy of whey associated with dodder seed extract on moderate-to-severe atopic dermatitis in adults: A randomized, double-blind, placebo-controlled clinical trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Atopic dermatitis is a common chronic inflammatory skin condition that is on the rise and adversely affects quality of life of the affected individual. Dry skin and pruritus, major characteristics of this disease, are associated with the dysfunction of the skin barrier. Though mild cases of the disease can be controlled with antihistamines and topical corticosteroids, moderate-to-severe cases often require treatment with immunomodulatory drugs, which have many side effects. It is now more common to use complementary and alternative medicines in the treatment of atopic dermatitis. In traditional Iranian medicine, the use of whey with the aqueous extract of field dodder (Cuscuta campestris Yunck.) seeds in severe and refractory cases of atopic dermatitis is common and has no side effects. The aim of this study was to assess the efficacy and safety of whey associated with dodder seed extract in the treatment of moderate-to-severe atopic dermatitis in adults. MATERIALS AND METHODS: The study was a randomized, double-blind placebo control trial that was conducted on 52 patients with moderate-to-severe atopic dermatitis for 30 days. In this study patients received freeze dried whey powder with spray dried water extract of field dodder or the placebo for 15 days. At baseline (week zero), after the end of the 15 day treatment period (week three) and 15 days after stopping the drug or placebo (follow-up/week five), patients were evaluated in terms of skin moisture, elasticity, pigmentation, surface pH and sebum content on the forearm with Multi Skin Test Center® MC1000 (Courage & Khazaka, Germany) and the degree of pruritus and sleep disturbance in patients were also recorded. RESULTS: 42 patients completed 30 days of treatment with the medicine and the follow-up period. At the end of the follow-up period a significant increase in skin moisture and elasticity in the group receiving whey with dodder was observed compared with the placebo group (p<0.001). There was a significant difference between the two groups regarding the pruritus after 15 days of receiving treatment or the placebo (p<0.05), and at the end of the 30-day study period the difference was clearly significant (p<0.001). Sleep disturbance showed significant changes at the end of follow-up period (p<0.05). There was no significant difference between the two groups concerning changes in skin pigmentation, however, a significant decrease was observed in the group receiving whey associated with dodder seed extract over time (p<0.001). There were no significant alterations in skin surface pH and the amount of sebum between the two groups. Temporary side effects were reported including anorexia and mild gastrointestinal problems in drug use. It is noteworthy that in this study despite the fact that patients received whey with dodder for just 15 days, moisture and elasticity of the skin continued to increase in the second half of the study (follow-up period). This shows that the effect of whey with dodder is not transient and this drug really helped skin barrier reconstruction and accelerated the healing process of skin. This positively influenced the skin parameters and consequently the improvement of pruritus and sleep disturbance. CONCLUSIONS: The results indicate that whey associated with dodder seed extract can serve as a promising alternative for the treatment of moderate-to-severe atopic dermatitis. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT2013121415790N1.

Epidemiological aspects of Pediculosis capitis and treatment evaluation in primary-school children in Iran.

This study was undertaken to assess the prevalence of and epidemiological factors associated with, head lice infections in Iranian primary schools in 2006 and evaluate data on the therapeutic efficacy of lindane shampoo. A total of 40586 children (19774 boys (48.72%) and 20812 girls (51.28%)] from 198 Governmentprimary schools in Kerman, were screened for head lice between March and June 2006. The diagnosis of head lice infestation was confirmed by clinical inspection of scalp and hair for the presence of adult lice nymphal stage, or eggs (nit) by line-toothed head lice comb. All children infested with lice were treated with lindane shampoo (1% gamma benzene hexachloride). The overall prevalence of head lice infestation was 1.8%. The prevalence of infestation was significantly higher in girls (2.9%) than in boys (0.6%) (p = 0.000). The infestation rate was greater among pupils who were living in rural areas (4.6%) than in urban areas (1.5%). Of the 721 children with a positive examination result, 424 pupils (58.8%) were reported as having been infested with head lice in the previous 6 months. Mother's education level was a significant risk factor in this model (p < 0.05). At 2 weeks after the primary treatment, the success rates of treatment were 49%. Comprehensive survey in our work showed the better future of the disease and related factors. Education campaigns by health care officials, physicians and teachers are expected to be helpful for head lice control. It is essential that governments should be supported form cooperation between the school authorities and public health centers to successful control head lice infestation in primary school. Also there is an urgent need to identify safe, novel insecticides for proved efficacy.

Evaluation of In Vitro Production of IFN-gamma, IL-10, IL-12 and IL-13 by Blood Cells in Patients with Cutaneous Leishmaniasis Lesions.

This study investigated the in vitro production of interferon-gamma, interleukin (IL)-10, IL-12, and IL-13, after antigenic stimulation of the cells (with Leishmania antigen and lipopolysaccharide) using whole blood from patients with cutaneous leishmaniasis lesions caused by Leishmania tropica and in normal volunteers with history of cutaneous leishmaniasis.ELISA results showed that the mean production of interferon-gamma by cells of whole blood in patients with lesions in response to Leishmania antigen was significantly lower than corresponding values in volunteers with history of cutaneous leishmaniasis (P< 0.05) and significantly higher levels of IL-10 production in patients with lesions were observed compared with cured volunteers of the disease (P<0.01). A similar level of IL-12, including p40 subunit of IL-12, was detected in both groups tested in this study in response to stimulation of parasite antigen. The levels of the IL-13 after stimulation with Leishmania antigen were significantly more in patients compared with volunteers with history of cutaneous leishmaniasis (P< 0.01). There was no significant difference in the mean production of IFN-gamma, IL-10, IL-12 and IL-13 by PHA or LPS stimulated cells from patients with lesions and volunteers with history of the disease, indicating that there was no qualitative defect in cytokine production in these patients.In this study, we have detected the decreased production of interferon- gamma by cells of patients with lesions of cutaneous leishmaniasis in response to parasite antigen and unbalanced production of regulatory cytokines such as IL-10 and IL-13 using the whole-blood stimulation assay technique. The required small volume of blood and the rapid set up time are the advantages in this assay technique. Using this assay for further immunodetection of cytokines may confirm its value for clinical investigation.

Alopecia areata in Darier disease and clinical findings in five affected family members.

A 32-year-old man known to have keratosis follicularis presented with a new problem of alopecia areata involving his scalp. His Darier disease had been present for 24 years and was manifested by pruritic eruptions that were more severe in the summer months. Other family members, including his father, brother, and two sisters suffered from similar skin manifestations.