COVID-19 infection and Leser-Trelat sign: Is there an association?

Key Clinical Message: The etiology of the Leser-Trélat sign is still unknown, it is likely that viral infections like COVID-19 can be associated with eruptive seborrheic keratosis, although the exact pathogenesis is still not clear, but this phenomenon can be due to TNF-alpha and TGF-alpha and immunosuppression condition as well as in COVID-19 infection. Abstract: Seborrheic keratosis is a typical benign skin lesion that is almost always seen in elderly populations. The sudden increase in size or an increase in the number of these lesions is called Leser-Trelat sign, this sign is suggesting as a paraneoplastic appearance of internal malignancy. But, Leser-Trelat sign is also described in some nonmalignant conditions, for example, human immunodeficiency virus infection and human papillomavirus infection. Herein, we describe a patient with Leser-Trelat sign after recovery from COVID-19 infection with no evidence of internal malignancy. This case was partially presented as a poster in the 102nd Annual Congress of British Association of Dermatologists in Glasgow, Scotland from July 5 2022 to July 7 2022. British Journal of Dermatology, 187, 2022 and 35. The patient signed written informed consent to permit the publication of the case report without identifying data and to use the photography for publication. The researchers committed to maintaining patient confidentiality. Institutional ethics committee approved the case report (ethics code: IR.sums.med.rec.1400.384).

The effect of air pollution on systemic lupus erythematosus: A systematic review and meta-analysis.

BACKGROUND: Systemic lupus erythematosus (SLE) is an autoimmune disease resulting from impaired inflammatory responses. Given the role of air pollution on increasing inflammatory mediators, thus, we aimed to systematically review and meta-analyze evidence regarding an association between short-term exposure to air pollution and SLE onset, activity, and hospitalization. METHODS: Electronic databases including Web of Science, PubMed, Scopus, and Embase were searched for all published articles until July 5, 2021. Newcastle Ottawa Scale (NOS) checklist was used to assess the quality of individual studies. Relevant demographic data and the intended results of the selected studies were extracted, and their adjusted risk ratios (RRs) were pooled using random and fixed effect analysis based on the heterogeneity index. FINDINGS: Twelve studies were entered in our systematic review, and finally, six publications were enrolled in meta-analysis. Overall, Meta-analysis showed no significant association between an increase of PM2.5 on the third day and SLEDAI score with pooled adjusted RR of 1.212 (95% CI, 0,853-1.721), p-value = 0.284. However, there was a positive relationship between 6 days increase of Particulate matter (PM) 2.5 and the systemic lupus erythematosus disease activity Index (SLEDAI) score (pooled adjusted RR 1.112; 95% CI, 1.005-1.231), p-value = 0.040. There was no significant association between carbon monoxide (CO), nitrogen dioxide (NO2), PM2.5, and PM10 increase in the air and hospitalization of SLE patients with pooled RR of 1.021 (95% CI, 0,986-1.1.057), p-value = 0.249, 1.034 (95% CI, 0.996-1.068); p-value = 0.079, 1.042 (95% CI, 0.994-1.092); p-value = 0.084 and 1.004 (95% CI, 0.996-1.013); p-value = 0.323, respectively. Also, analysis showed a significant relation between ozone (O3) increase and hospitalization with a pooled RR of 1.076 (95% CI, 1.009-1.147); p-value = 0.025. Finally, analysis of SO2 increase and risk of hospitalization demonstrated no significant relationship with the pooled RR of 1.011; (95% CI, 0.962-1.062), p-value = 0.0.671. CONCLUSION: Our findings prove that PM2.5 was associated with increased SLE risk. We also showed that only O3 was associated with increased hospital admissions of SLE patients.

Complementary and integrative remedies in the treatment of chronic pruritus: A review of clinical trials.

BACKGROUND: Chronic pruritus is one of the most common conditions in dermatology and a common manifestation in many systemic diseases. Since the etiology of chronic pruritus remains somewhat unknown, hence, conventional medications may not always show a good therapeutic response. This finding has led both investigators and patients to use herbal and complementary remedies for its treatment. The aim of this study was to review clinical trials in which herbal and complementary medicine was used in the control and treatment of chronic pruritus. MATERIALS AND METHODS: In this study, we reviewed related articles in this domain, from 2000 to 2020. The search involved electronic databases including PubMed, Scopus, Web of Science, Cochrane, Google Scholar, and SID databases using the keywords "pruritus," "itch," "herb," "complementary medicine," "traditional medicine," "integrative medicine," and their related MeSH terms. Finally, we extracted the pertinent information from these articles and summarized the results. RESULTS: The findings of this study showed that 17 clinical trials have been conducted till date in order to evaluate the efficacy of herbal remedies and complementary medicines in the treatment of chronic pruritus. Herbal remedies including turmeric, Fumaria parviflora, Avena sativa, capsaicin, sweet almond oil, peppermint oil, violet oil, vinegar, as well as manual therapies including aromatherapy, auricular acupressure, and acupuncture, were significantly effective in the treatment of chronic pruritus. CONCLUSION: There are only a few studies published on the therapeutic efficacy of herbal remedies and complementary medicine in the treatment of chronic pruritus. Some have shown promising results. Therefore, more evidence-based studies are needed in order to determine if herbal remedies and complementary medicine could be an effective alternative or adjuvant treatment modality in chronic pruritus.

Lettuce as an Effective Remedy in Uremic Pruritus: Review of the Literature Supplemented by an In Silico Study.

Uremic pruritus is a frequent and prominent symptom in patients with advanced or end-stage renal disease. Lack of an effective treatment for kidney disease-associated pruritus often leads to many problems for these patients and makes it difficult to choose an appropriate treatment. The purpose of this evidence-based hypothesis is to share the scientific reasons and related mechanisms in order to claim that lettuce could be useful in the treatment of uremic pruritus. This hypothesis is based on studies related to lettuce and its anti-inflammatory, antioxidant, antidiabetic, sedative, hypnotic, nephroprotective, potassium balancing, and blood purification properties. As a result, we suggest that lettuce could be a good choice for improving and reducing uremic pruritus due to its certain characteristics. Although proof of this hypothesis requires further clinical trial studies, this hypothesis can nevertheless lead to formulating an appropriate therapy for uremic-induced pruritus. By conducting a molecular docking study, we investigated the interactions between nineteen natural bioactive components of lettuce (Lactuca sativa L.) and human kappa opioid receptors. The in silico docking studies revealed that most of the ligands showed better antipruritic efficacy than gabapentin. Gamma-tocopherol, delta-tocopherol, and campesterol demonstrated the highest binding affinities toward the target protein.

The effect of integration of basic and clinical aspects of a specific topic in a parasitology course on medical students learning: A randomized controlled trial.

BACKGROUND AND AIM: Parasitology course is one of the basic science courses in the educational curriculum for medical students. Since the integration of basic and clinical sciences has helped students better understand the basic science course content, the aim of the present study was to determine the effect of integration of basic and clinical aspects of a specific topic in a parasitology course on medical students learning. MATERIALS AND METHODS: A randomized controlled trial was conducted on 110 undergraduate fifth-semester medical students from April to July 2018. The students were randomly divided into two groups, based on student identification number: Intervention and control groups. The topic selected for this study from the parasitology course was "cutaneous leishmaniasis." At the beginning of the program, a dermatologist presented the clinical aspects of the topic to the intervention group. Then, a parasitologist delivered a traditional lecture about the basic aspects of the topic to both groups. The students' scores on questions related to cutaneous leishmaniasis in the final exam were used as a measure of learning and teaching outcomes. A questionnaire that consisted of seven items and three open-ended questions was used based on the objectives of the randomized controlled trial. Statistical analysis was performed by SPSS software. RESULTS: Based on the result of the final examination, there was no significant difference in the learning rate of students between the intervention and control groups (P ≥ 0.05). According to students' comments, the teaching of clinical science alongside basic science increased the importance of the topic and the students' interest in basic science. Most students agreed that this method prepares them for their clinical years. CONCLUSION: Many medical students believe that the content of many basic science courses are forgotten in the future. Therefore, basic science education alongside clinical science presentations are suggested.

Family dermatology life quality index in patients with pemphigus vulgaris: A cross-sectional study.

BACKGROUND AND AIMS: Pemphigus vulgaris is a rare autoimmune intraepidermal vesiculobullous disease involving the skin and mucosa. It impacts the quality of life of both patients and their families. METHODS: A total of 70 patients with pemphigus vulgaris (either outpatient or hospitalized) were enrolled using the simple sampling method between 2016 and 2017 from the dermatology clinic at Faghihi Hospital, Shiraz, Iran. A validated Persian version of the Family Dermatology Life Quality Index (FLDQI) questionnaire was filled by a family caregiver. The questionnaire contained 10 items assessing the quality of life of the family. Demographic variables were recorded in a separate form. RESULTS: The mean age of the patients was 51 ± 11.3 years and that of the family caregivers was 32 ± 8.8 years. The FLDQI score was higher (poorer quality of life) if the patient was male, older, had shorter disease duration or had fewer disease recurrences (P = 0.046, 0.01, 0.001 and >0.001, respectively). Higher scores were also obtained in the less-educated caregivers (P = 0.026) but there was no association with either gender or age (P = 0.399, 0.1). CONCLUSION: Pemphigus vulgaris significantly affects the Family Dermatology Life Quality Index. Education and counseling of family caregivers by various support groups such as Pemphigus Family Associations could be effective in improving the quality of life of the caregivers. LIMITATIONS: This study did not assess the effect of comprising domain analysis, severity of disease, patients' Dermatology Life Quality Index (DLQI), mucosal involvement, response to treatment, outpatient or admitted status, socioeconomic status, or the quality of life among the various family members.

Assessing the quality of life in the families of patients with epidermolysis bullosa: The mothers as main caregivers.

BACKGROUND: Epidermolysis bullosa (EB) is an uncommon group of inherited disorders characterized by skin blistering after friction or mechanical trauma. EB affects patients and their families physically, socially, and emotionally. OBJECTIVE: This study aimed to assess the family quality of life of these patients using the Family Dermatology Life Quality Index (FDLQI) questionnaire. METHODS: In this cross-sectional study, we enrolled caregivers of patients with EB registered at the Molecular Dermatology Research Center, affiliated with Shiraz University of Medical Sciences, up to 2020. Participants filled out a demographic data collection form and the FDLQI questionnaire. The data were analyzed using SPSS software, version 22. RESULTS: Overall, 80 participants, consisting of 65 mothers (81.2%) and 15 fathers (18.7%) as primary caregivers, were enrolled in this study. The average FDLQI score was 19.88 ± 4.71. The FDLQI scores of caregivers of patients with EB simplex was significantly lower than scores observed in those with other types of EB (p < .001). There was a significant positive association between the number of patients with EB in the family and FDLQI score (p = .049). FDLQI scores were lower in caregiving mothers who had a higher education (p < .001) and those who were employed (p < .001). CONCLUSION: Family quality of life is affected in patients with EB. Families with lower socioeconomic status and unemployed caregivers require special attention. More studies are needed to determine the parameters involved in the quality of life of patients with EB and their families.

The Evaluation of Serum Lipids Profile in Patients with Pemphigus Vulgaris: A Case-Control Study.

BACKGROUND: Pemphigus vulgaris (PV) is a chronic autoimmune disease. Dyslipidemia, increased risk of atherosclerosis and higher cardiovascular morbidity, and mortality have been reported in several autoimmune conditions. It has been hypothesised that there might be an association between dyslipidemia and PV. Therefore, the objective of this study was to compare the serum lipid profile of patients with PV with healthy controls. METHODS: This case-control study was carried out on 113 patients with PV and 100 healthy controls. Total cholesterol, high-density lipoprotein (HDL) and triglycerides (TG) levels were measured and low-density lipoprotein (LDL), non-HDL cholesterol (non-HDL-C) and atherogenic index of plasma (AIP) were calculated. Chi-squared test and independent Student t-test (or their alternatives) were used for group comparison. RESULTS: The mean age and BMI of patients and controls were 47.7 ± 14.5 and 28 ± 6.2 and, 44.5 ± 18.5 and 25.5 ± 5.1, respectively. Total cholesterol, LDL, HDL, non-HDL-C and TG were statistically different between the two groups (P values < 0.001; < 0.001; < 0.001; < 0.001 and 0.021, respectively). However, AIP was not significantly different (P-value = 0.752). CONCLUSION: The serum lipid profile was significantly higher in PV patients compared to healthy controls. Therefore, PV patients may be more prone to develop atherosclerosis and this finding can be important in the overall management of these patients.

Psychodermatology in Iran: A survey on knowledge, awareness, and practice patterns in Iranian dermatologists.

Psychodermatology is an interdisciplinary field in dermatology which involves the interaction between mind and skin. Studies from various parts of the world demonstrate generalized lack of knowledge regarding psychocutaneous disorders among dermatologists. We provide this survey to evaluate the knowledge, awareness, and practice patterns of Iranian dermatologists about psychodermatology. A survey questionnaire on the topic of this study was randomly distributed among Iranian dermatologists in a national dermatology conference and also by mail. All collected data were entered into SPSS software version 20.0 and were analyzed using descriptive statistics. The questionnaires were filled out by 65 dermatologists aged 30 to 60 years. From this group, 60% (39) were male and 40% (26) were female. About 86% of the dermatologists saw more than 30 psychodermatology patients weekly and about 43% mentioned they felt somewhat comfortable managing psychodermatology patients. Alopecia, vitiligo, and acne were the most common primary dermatology diseases with secondary psychiatric problems. More than half of our responders mentioned that they did not take any psychodermatology courses during their training program. However, about 66% of the dermatologists expressed interest in participating in psychodermatology continuing medical education programs. Further collaboration between dermatologists and psychiatrists can shape a brilliant future in psychodermatology and improve the quality of life of patients. We highly recommend educational courses in psychodermatology for both dermatologists and psychiatrists.

Overview of herbal and traditional remedies in the treatment of cutaneous leishmaniasis based on Traditional Persian Medicine.

This study aims to describe the herbal and traditional remedies in the treatment of cutaneous leishmaniasis (CL) with an overview on related available evidence in modern medicine. This study is a review that focuses on the most important Traditional Persian Medicine (TPM) sources including Avicenna's Canon of Medicine, Jorjani's Zakhira-yi Kharazmshahi, and Aazam-Khan's Eksir-e-Aazam, as well as pertinent information from Embase, PubMed, Scopus, Scientific Information Database, and Google Scholar by using the keywords salak, rish-e-balkhi, cutaneous leishmaniasis, and leishmaniasis for selected remedies. Several oral and topical herbal remedies, such as Vitis vinifera L. (Unripe grapes), Berberis vulgaris L., Rheum ribes L., Santalum album L., Cinnamomum camphora (L.) J.Presl (Camphor), Brassica nigra (L.) K. Koch, Crocus sativus L., Juniperus excelsa M. Bieb, honey, and Alum root, were mentioned in TPM resources for the treatment of CL. Furthermore, cauterization, cupping, and leech therapy were considered for this purpose. In this review, some evidence-based studies will also be presented that have demonstrated the therapeutic properties of some of these products. In conclusion, the sages of TPM have recommended several systemic or topical medications, in addition to physical procedures, for treatment of CL, all of which could be a base for conducting further research on its efficacy.

CO2 laser treatment for plantar warts in children: A case series.

Several types of human papillomaviruses induce warts. Warts are one of the most common infections in childhood with a reported prevalence of up to 20%. Warts are divided clinically into genital and nongenital forms. Plantar warts are common nongenital warts. In this series, five pediatric cases treated with CO2 laser for their plantar warts are presented. One patient was a known case of Hodgkin's lymphoma. Three of our patients had history of unsuccessful treatments with other modalities, while the other had received no previous treatment. CO2 laser with continuous mode (focused and defocused) was used. In our cases, only one session was enough for clearance of the warts. All the patients were visited 1 week and 3 months after treatment to assess the efficacy and any possible recurrences. Follow-up showed that all the patients remained in remission up to 3 months posttreatment with no adverse events.

Patients' preferences of cutaneous leishmaniasis treatment outcomes: Findings from an international qualitative study.

BACKGROUND: Cutaneous leishmaniasis (CL) is a disease that often affects exposed skin areas and may heal leaving lifelong scars. Patients' expectations from treatment are rarely considered in drug development for CL. An initiative aiming to address shortcomings in clinical trial design and conduct for CL treatments involving the researchers' community is on-going. This manuscript presents patient-preferred outcomes for CL and an assessment on how to consider these in the conduct of future trials. METHODOLOGY/PRINCIPAL FINDINGS: We report preferred treatment outcomes by 74 patients with confirmed CL in endemic regions of Brazil, Burkina Faso, Colombia, Iran, Morocco, Peru and Tunisia during individual in-depth interviews. Beyond outcomes customarily considered in trials (such as lesion appearance and adverse events), patients talked about a large number of outcomes related to quality of life, such as pain, scar formation, and others affecting their work and daily activities. They also reported fears around getting rid of the parasite, disease recurrence, and possible sequelae. CONCLUSIONS/SIGNIFICANCE: The study results provide a rich insight into important outcomes for CL treatments, as well as related topics, from the perspective of a diverse patient population. Among the outcomes identified, we argue that those related to quality of life as well as recurrence should be included to a greater extent for assessment in clinical trials, and discuss the suitability of measurement instruments such as the Dermatology Quality of Life Index (DLQI). Interviews also point out the potential need to address concerns related to parasitological cure or scar formation, such as social stigmatization and disability. In addition, patients should be given information in order to clarify reported misconceptions. This study therefore suggests a methodology for consulting CL patients on outcomes as elements of clinical trial design, and how to incorporate these outcomes in trials. It also discusses how reported outcomes could be addressed in clinical care.

Evaluating prevalence of depression, anxiety and hopelessness in patients with Vitiligo on an Iranian population.

INTRODUCTION: Vitiligo is caused by partial or complete destruction of melanocytes in the affected skin area and influences the patient's quality of life. Besides physical involvement, vitiligo patients experience a high level of stress. Depression and Anxiety are common psychiatric disorders in vitiligo patients. AIM: This study, as the first study, evaluates hopelessness, anxiety, depression and general health of vitiligo patients in comparison with normal controls in an Iranian population. METHOD: Hundred patients with vitiligo and hundred healthy controls were examined. General health, depression, hopelessness and anxiety were evaluated based on general health questionnaire. Anxiety, depression and hopelessness levels were analyzed using Chi-Square, and the mean value of general health was evaluated through t-test. RESULTS: The results showed that anxiety and hopelessness levels were significantly higher in vitiligo patients than those who are in healthy controls. This significant difference refers to high levels of anxiety and hopelessness among women with vitiligo. It was also found that the single patients were more anxious, hopeless and depressive, while the married patients were only more anxious and hopeless than those who are in the control group, respectively. General health of patients was significantly worse than in healthy controls. The low level of general health in patients was related to poorer level of general health among women with vitiligo. CONCLUSION: It seems that women with vitiligo are more mentally stressed than men with vitiligo. Both singles and married vitiligo patients suffer from anxiety and hopelessness.

Leishmania cytochrome b gene sequence polymorphisms in southern Iran: relationships with different cutaneous clinical manifestations.

BACKGROUND: Cutaneous leishmaniasis (CL) caused by Leishmania species, is a geographically extensive disease that infects humans and animals. CL is endemic in half of the 31 provinces of Iran, with 29,201 incidence cases reported in Fars province from 2010 to 2015. CL is polymorphic and may result in lesions characterized by different clinical features. Parasite genetic diversity is proposed to be one of the factors affecting the clinical outcome and lesion characteristics in CL patients. However, there is still very limited data regarding the genetic variation of Leishmania spp. based on the sequencing of Cytochrome b (Cyt b) gene. METHODS: All patients originated from endemic regions in Fars province. The amplification of the Cyt b gene from isolates of 100 patients with disparate clinical forms of CL was accomplished using Nested-PCR. Sequence analysis of the amplified Cyt b was used to scrutinize the genetic variations among Leishmania isolates and connect the results with clinical pictures. The clinical demonstrations were basically of two types, typical and atypical lesions. Molecular phylogenetic tree was constructed using the Neighbor-Joining method, with species/strains from this study compared to species/strains from other geographical regions. RESULTS: Leishmania major was identified as the predominant infecting Leishmania spp. (86% of cases), with the remainder of cases being infected by Leishmania tropica. Clinical examination of patients revealed 12 different clinical CL forms. Among Leishmania samples analyzed, five distinct haplotypes were recognized: three in L. major and two in L. tropica. We found a correlation between clinical outcomes and Cyt b sequence variation of Leishmania spp. involved. Moreover, we observed a higher presence of polymorphisms in L. major compared with L. tropica. This difference may be due to the different eco-epidemiologies of both species, with L. tropica being an anthroponosis compared to L. major, which is a zoonosis. CONCLUSIONS: The sequence analysis of Cyt b gene from 25 L. major and L. tropica strains demonstrated genetic variability of L. major and L. tropica causing CL in southern Iran, and a feasible connection amid the genetic heterogeneity of the parasite, geographical source and clinical appearance of the disease in human was detected.

Real life management of chronic urticaria: Multicenter and cross sectional study on patients and dermatologists in Iran.

Recently, advances in understanding the etiology of urticaria and updates of diagnostic and therapeutic management guidelines have drawn attention to chronic urticaria (CU) morbidity. The present study aimed to evaluate Iranian dermatologists' practice and real life management of CU patients. A total of 35 dermatologists and 443 patients were included in the study. Number of female patients was 321 (72.5%). Mean (standard deviation) age of the study patients was 38 (13) years and the median (inter quartile range) of disease duration was 12 (6-48) months. Severity of patients' symptoms was mild for 32.1%, moderate for 38.7%, severe for 18.8%, and 10.4% of them had no evident signs or symptoms. The most common diagnostic methods were physical examination (96.6%), differential blood count (83.5%), erythrocyte sedimentation rate (77.4%), and C-reactive protein (62.8%). The number of dermatologists prescribed nonsedating antihistamines (nsAH) in regular dose and high dose mono therapy were 26 (74%) and 6 (17%), respectively. About 66% of dermatologists were familiar with British Association of Dermatologists (BAD) guideline. The most common first-line treatment for CU by Iranian dermatologists was nonsedating antihistamines in regular or high doses. The real-life management of patients with CU in Iran was in accordance with the available practice guidelines.

Cryotherapy versus CO2 laser in the treatment of plantar warts: a randomized controlled trial.

BACKGROUND: Warts are one of the most common infections in humans. Plantar warts are a subtype of non-genital warts, and several procedures and topical treatments have been used in its treatment. Cryotherapy is one of the most popular modalities, but it is time-consuming and remission rates vary in different studies. CO2 laser was the first laser used for treating warts. To date, no clinical trial has been done to compare CO2 laser with cryotherapy in the treatment of plantar warts. PATIENTS AND METHODS: This randomized controlled trial was performed in order to compare the efficacy and number of sessions needed to treat plantar warts in 60 patients who had received no previous treatment in the previous 3 months. They were randomly allocated to the cryotherapy or CO2 laser group. The number of sessions needed for response and the recurrence rate after a 3-month follow-up was compared in the 2 groups. RESULTS: Sixty patients with plantar warts were randomly allocated to either the CO2 laser or cryotherapy groups. Median age was 25 (range=18-53) and 27 (range= 18-75) years in the cryotherapy group and CO2 laser groups, respectively. Both groups were matched for age and sex (56% male and 44% female in the cryotherapy group and 34% male and 66% female in the CO2 laser group). The median number of sessions needed for complete resolution of the warts in the CO2 laser and cryotherapy groups were 1 (range=1-2) and 3 (range=1-12), respectively. The difference in the number of sessions was statistically significant between the 2 groups (P-value≤0.001). Recurrence rates after a 3-month follow-up was not statistically significant (P-value= 0.069). CONCLUSION: The number of sessions needed to treat plantar warts was less using CO2 laser than cryotherapy; therefore, this modality can be a good addition to the already existing anti-wart armamentarium.

The myrtus communis L. solution versus ketoconazole shampoo in treatment of dandruff: A double blinded randomized clinical trial.

OBJECTIVE: To evaluate the efficacy and safety of myrtus communis L. solution in the treatment of dandruff and to compare it with ketoconazole. METHODS: This double-blind randomised clinical trial was conducted at Shiraz University of Medical Sciences, Shiraz, Iran, from December 2015 to August 2016, and comprised patients with dandruff aged 18-60 years visiting the dermatology out-patient clinic. The subjects were randomised into two equal groups. The treatment group received myrtus communis L. solution and a placebo shampoo, while the control group received ketoconazole shampoo and a placebo solution. The total duration of the study for each subject was one month and subjects in both groups used their respective interventions 8 times during that period. The parameters studied were pruritus, erythema, severity of scaling, and the extent of scalp involvement. All subjects underwent scalp scaling tests at the beginning, after 10 days and at the end of the 30th day. SPSS 21 was used for data analysis. RESULTS: Of the 90 individuals, there were 45(50%) in each of the two groups. However, 74(82%) subjects completed the third visit and, of them, there were 37(50%) in each group. Both groups showed significant improvement in all outcome measures (p<0.001). There were no significant differences between the groups in terms of efficacy, satisfaction rate and side effects (p>0.05 for each outcome). CONCLUSIONS: Myrtus solution was found to be effective in the treatment of dandruff.

An international qualitative study exploring patients' experiences of cutaneous leishmaniasis: study set-up and protocol.

INTRODUCTION: Lack of investments in drug development, lack of standardisation of clinical trials and the complexity of disease presentations contribute to the current lack of effective, safe and adapted treatments for cutaneous leishmaniasis (CL). One aspect concerns outcomes affecting patients' quality of life (QoL): these are hardly assessed in trials, despite potential functional and/or aesthetic impairment caused by CL, which typically affects disadvantaged and vulnerable people living in rural areas. Here, we describe the approach used to bring perspectives of patients with CL into designing and assessing treatments. METHODS AND ANALYSIS: This international qualitative study uses interviews with patients to explore their experiences with CL to (1) elicit outcomes and eligibility criteria for clinical trials important to them and (2) to better understand their needs and views about the disease and their requirements and expectations from treatment. Here, we describe the set-up of this collaborative study and the protocol. Data collection is ongoing.The protocol includes study design, preparation, conduct and analysis of individual interviews with approximately 80 patients in seven countries (Burkina Faso, Brazil, two sites in Colombia, Iran, Morocco, Peru and Tunisia) where CL is prevalent. Principal investigators and sites were selected through an open call, and two workshops were organised for protocol development and training in conduct and analysis of qualitative health research. Patient recruitment aims at covering a maximum variation of experiences. Transcripts will be analysed to identify outcomes and eligibility criteria as well as further topics that are expected to emerge from the interviews, such as direct and indirect costs related to CL, its psychological impact, preferred modes of drug administration and traditional treatments. ETHICS AND DISSEMINATION: The study received ethical approval by the responsible committees of each of the participating institutions. Findings will be disseminated through publication in peer-reviewed journals, scientific meetings and to participants and their communities.

Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation.

INTRODUCTION: Progress with the treatment of cutaneous leishmaniasis (CL) has been hampered by inconsistent methodologies used to assess treatment effects. A sizable number of trials conducted over the years has generated only weak evidence backing current treatment recommendations, as shown by systematic reviews on old-world and new-world CL (OWCL and NWCL). MATERIALS AND METHODS: Using a previously published guidance paper on CL treatment trial methodology as the reference, consensus was sought on key parameters including core eligibility and outcome measures, among OWCL (7 countries, 10 trial sites) and NWCL (7 countries, 11 trial sites) during two separate meetings. RESULTS: Findings and level of consensus within and between OWCL and NWCL sites are presented and discussed. In addition, CL trial site characteristics and capacities are summarized. CONCLUSIONS: The consensus reached allows standardization of future clinical research across OWCL and NWCL sites. We encourage CL researchers to adopt and adapt as required the proposed parameters and outcomes in their future trials and provide feedback on their experience. The expertise afforded between the two sets of clinical sites provides the basis for a powerful consortium with potential for extensive, standardized assessment of interventions for CL and faster approval of candidate treatments.

Interleukin-10 and Interferon-γ Levels in Patients with Cutaneous Leishmaniasis Treated with Cryotherapy.

Pentavalent antimonials, as the 1st choice for the treatment of cutaneous leishmaniasis (CL), have various side effects. Also, there are some reports of drug resistance. Due to its safety, cryotherapy can be a good alternative or complementary treatment in CL. The aim of this study was to explore the possible systemic immunological mechanisms of cryotherapy besides its local effects in the treatment of CL. Twenty patients with CL were selected. The disease was confirmed via a direct smear. A venous blood sample was collected to determine IL-10 and IFN-γ levels before starting cryotherapy. Then, 1 week after 8 sessions of cryotherapy were completed (i.e., 63 d), a 2nd venous sample was taken in order to compare the results with the pretreatment levels of these cytokines using the ELISA method. Cryotherapy resulted in no change in the levels of IL-10 and significantly increased the IFN-γ levels in our patients with CL. Given these inconclusive or even mixed results, a larger sample size is needed in order to better assess the systemic immunological effects of cryotherapy.