Treatment with stromal vascular fraction of Peyronie's disease - a study protocol.

INTRODUCTION: Peyronie´s disease is the result of an acquired fibrotic plaque in the tunica albuginea. It remains unknown why the condition appears, but it seems to affect up to 9% of all men. It can result in a debilitating curvature of the erect penis, which has extensive impact on the quality of life for many men. Thus, the disease may result in low self-esteem, depression and impaired sexual performance. METHODS: This is a prospective pilot study investigating the feasibility and safety of stromal vascular fraction injection into the plaque of 22 men with Peyronie´s disease in the chronic phase. The stromal vascular fraction is obtained from a small liposuction of 250 ml fat in general anaesthesia and injected the same day. CONCLUSION: We hope to show that injection of stromal vascular fraction is safe and effective in reducing curvature in men with Peyronie´s disease. FUNDING: The study was made possible with funding from: the Region of Southern Denmark, Louis-Hansen Fund, Lizzi and Mogens Staal Fund, Karola Jørgensen Fund, Marie and Børge Kroghs Fund, the Senior Doctors Research Fund OUH, the Fund for gentle Surgery OUH and the PhD fund of the executive board of the South West Denmark Hospital. The funding sources had no influence on the trial design, data collection, analysis or publication. CLINICALTRIALS: gov NCT04771442, EudraCT 2020-004297-22, Danish Medicines Agency 2020090057, National Ethics Committee 74705 and Danish Data Protection Agency (record no. 1/21757).

Deep learning for AI-based diagnosis of skin-related neglected tropical diseases: A pilot study.

BACKGROUND: Deep learning, which is a part of a broader concept of artificial intelligence (AI) and/or machine learning has achieved remarkable success in vision tasks. While there is growing interest in the use of this technology in diagnostic support for skin-related neglected tropical diseases (skin NTDs), there have been limited studies in this area and fewer focused on dark skin. In this study, we aimed to develop deep learning based AI models with clinical images we collected for five skin NTDs, namely, Buruli ulcer, leprosy, mycetoma, scabies, and yaws, to understand how diagnostic accuracy can or cannot be improved using different models and training patterns. METHODOLOGY: This study used photographs collected prospectively in Côte d'Ivoire and Ghana through our ongoing studies with use of digital health tools for clinical data documentation and for teledermatology. Our dataset included a total of 1,709 images from 506 patients. Two convolutional neural networks, ResNet-50 and VGG-16 models were adopted to examine the performance of different deep learning architectures and validate their feasibility in diagnosis of the targeted skin NTDs. PRINCIPAL FINDINGS: The two models were able to correctly predict over 70% of the diagnoses, and there was a consistent performance improvement with more training samples. The ResNet-50 model performed better than the VGG-16 model. A model trained with PCR confirmed cases of Buruli ulcer yielded 1-3% increase in prediction accuracy across all diseases, except, for mycetoma, over a model which training sets included unconfirmed cases. CONCLUSIONS: Our approach was to have the deep learning model distinguish between multiple pathologies simultaneously-which is close to real-world practice. The more images used for training, the more accurate the diagnosis became. The percentages of correct diagnosis increased with PCR-positive cases of Buruli ulcer. This demonstrated that it may be better to input images from the more accurately diagnosed cases in the training models also for achieving better accuracy in the generated AI models. However, the increase was marginal which may be an indication that the accuracy of clinical diagnosis alone is reliable to an extent for Buruli ulcer. Diagnostic tests also have their flaws, and they are not always reliable. One hope for AI is that it will objectively resolve this gap between diagnostic tests and clinical diagnoses with the addition of another tool. While there are still challenges to be overcome, there is a potential for AI to address the unmet needs where access to medical care is limited, like for those affected by skin NTDs.

Evaluation of the safety and efficacy of platelet-rich plasma in the treatment of female patients with chronic telogen effluvium: A randomised, controlled, double-blind, pilot clinical trial.

BACKGROUND: Chronic telogen effluvium is characterised by diffuse loss of hair of the scalp. One of the emerging lines of treatment is platelet-rich plasma. However, not much of published data exist. AIMS: A pilot study was conducted on chronic telogen effluvium patients to evaluate the efficacy and safety of platelet-rich plasma, and to compare two different methods of platelet-rich plasma preparation. METHODS: The study included 30 female patients with chronic telogen effluvium. Patients were randomised into three groups: Group (1): Special platelet-rich plasma tubes centrifuged at 3500 rpm; Group (2): Ordinary laboratory tubes centrifuged at 1000 rpm; Group (3): Normal saline as a placebo. Patients' evaluation was done with visual analog scale, hair pull test, trichoscopy, photos, satisfaction questionnaire, and safety. All patients received four monthly sessions. Patients were evaluated one month and three months after the last session. RESULTS: The hair pull test,visual analogue scale, and patient satisfaction results showed a statistically significant difference between group 1 vs. group 3 and group 2 vs.group 3 at one and three months after the sessions, while there was no difference between group1 vs. group 2. Trichoscopy results (baseline, one and three months after treatment) showed a significant increase in hair density and thickness in the frontal area, temporal area, and the vertex in groups 1 and 2 only. There was no statistically significant difference between the three groups with regards to side effects. LIMITATIONS: The sample size was small with ten patients in each group. Furthermore, the follow-up of patients was for only three months. CONCLUSIONS: Platelet-rich plasma could be considered as a promising therapy for patients with chronic telogen effluvium with an excellent safety profile. The ordinary laboratory low-cost tubes might be a reliable alternative to the expensive special platelet-rich plasma kits tubes. The trial registry number is PACTR202006539654415.

Comparative study of the efficacy and safety of two grafting procedures (an automated epidermal harvesting system and non-cultured epidermal cell suspension) in the treatment of stable vitiligo.

Background The non-cultured epidermal cell suspension method is a well-established but tedious grafting modality in the management of stable vitiligo. Recently a more user-friendly automated epidermal harvesting system has been introduced. Aim This was a pilot study to compare the efficacy and safety outcomes of the above two grafting procedures. Study design The study was a single-blinded split-body randomised controlled trial. After scientific and ethical clearance, the trial was registered with CTRI (CTRI/2018/05/014225). Thirty consenting patients of stable vitiligo with 60 near-symmetrical patches were recruited. Block randomisation was done using computer-generated randomisation software and each patch was allocated either of the two grafting modalities. Efficacy was assessed by the Physician Global Assessment Scale on serial images and pain by the Numerical Rating Pain Scale. Results and conclusion The non-cultured epidermal cell suspension was found to be an overall statistically superior technique to the automated epidermal harvesting system in terms of efficacy (re-pigmentation). Both donor and recipient site complications were significantly less with the automated epidermal harvesting system grafting and this method had the distinct advantage of being a painless and easy technique with minimal recovery time. A novel observation was that a good colour match and near-complete re-pigmentation occurred in patients with a darker skin colour with both techniques. Limitations The main limitation of our study was the small sample size. Also, the size of the treated patches was limited such that they could be covered by the 5 × 5 cm size of the automated epidermal harvesting system blade. However, a larger area can be covered with multiple sessions.

Multiplex peptide microarray profiling of antibody reactivity against neglected tropical diseases derived B-cell epitopes for serodiagnosis in Zimbabwe.

INTRODUCTION: Peptides (B-cell epitopes) have broad applications in disease diagnosis and surveillance of pathogen exposure. In this framework, we present a pilot study to design and produce a peptide microarray for the integrated surveillance of neglected tropical diseases. The peptide microarray was evaluated against peptides derived from Ascaris lumbricoides, Necator americanus, Schistosoma haematobium, Schistosoma mansoni, Trichuris trichiura, Bacillus anthracis, Mycobacterium leprae, Wuchereria bancrofti, Rabies lyssavirus, Chlamydia trachomatis and Trypanosoma brucei. METHODS: S. haematobium was diagnosed using the urine filtration technique. S. mansoni, A. lumbricoides, N. americanus and T. trichiura were diagnosed using the Kato Katz and formal ether concentration techniques. Immunogenic peptides were retrieved from the Tackling Infection to Benefit Africa infectious diseases epitope microarray. Further peptides were predicted using ABCpred. IgG and IgM reactivity against the derived peptides were evaluated using peptide microarray multiplex immunoassays. Positive response was defined as fluorescence intensity ≥ 500 fluorescence units. Immunodominant peptides were identified using color-coded heat maps and bar graphs reflecting the obtained fluorescence signal intensities. Receiver Operating Characteristic analysis and Mann-Whitney-U test were performed to determine the diagnostic validity of the peptides. RESULTS: Species-specific responses with at least one peptide derived from each NTD pathogen were observed. The reactive peptides included; for S. haematobium, XP_035588858.1-206-220 and XP_035588858.1-206-220 immunodominant for IgG and IgM respectively, for S. mansoni, P20287.1-58-72 immunodominant for both antibodies and for T. trichiura, CDW52482.1-326-340 immunodominant for IgG and CDW57769.1-2017-2031 and CDW57769.1-1518-1532 immunodominant for IgM. According to ROC analysis most of the peptides selected were inaccurate; with AUC < 0.5. Some peptides had AUC values ranging from 0.5 to 0.5875 for both IgM and IgG suggesting no discrimination. CONCLUSION: Multiplex peptide microarrays are a valuable tool for integrated NTDs surveillance and for screening parasites exposure in endemic areas. Species sero-reactivity observed in the study maybe indicative of exposure to the different NTDs parasites. However, although peptides with the least cross reactivity were selected there is need to validate the sero-reactivity with recombinant antigens and immune-blotting techniques such as western blotting.

Effectiveness and safety of topical amphotericin B in 30% dimethyl sulfoxide cream versus 30% dimethyl sulfoxide cream for nondermatophyte onychomycosis treatment: A pilot study.

Background Although topical amphotericin B cream is effective for the treatment of nondermatophyte mold onychomycosis in vitro, studies of its effectiveness and safety in vivo are limited. Objectives We studied the effectiveness and safety of topical 0.3% amphotericin B in 30% dimethyl sulfoxide cream (amphotericin B cream) in nondermatophyte mold onychomycosis using the vehicle cream 30% dimethyl sulfoxide cream as control. Methods This randomized controlled study was conducted between January 2019 and November 2020. Patients diagnosed with nondermatophyte mold onychomycosis were randomly divided into two groups of ten patients each: one treated with amphotericin B cream and the other with the vehicle cream. Clinical and mycological cure as well as safety were evaluated. Results Ten patients each treated with amphotericin B cream and the vehicle cream were included in the study, but only nine patients in the vehicle cream group were available for follow up. All the 19 evaluable patients had distal lateral subungual onychomycosis and the great toenails were affected in 18 (94.7%) of these. Mycological cure was achieved in 8 (80%) patients treated with amphotericin B cream and in 4 (44.4%) patients using the control (vehicle) cream. Clinical cure was achieved in 7 (70%) patients treated with amphotericin B cream, but only in 2 (22.2%) patients on the control cream. No adverse events were observed. Limitations The small sample size and the fact that PCR fungal identification that provides accurate identification of fungal species was not performed are limitations of our study. Conclusion Topical amphotericin B cream was both very effective and safe in the treatment nondermatophyte mold onychomycosis. The control (vehicle) cream containing 30% dimethyl sulfoxide also demonstrated some antifungal activity.

A pilot study to determine Neisseria gonorrhoeae-Chlamydia trachomatis coinfection rates in symptomatic patients attending STI Clinics, New Delhi, India.

BACKGROUND: Neisseria gonorrhoeae and Chlamydia trachomatis are the two most prevalent bacterial sexually transmitted infections. For over two decades, treatment guidelines have recommended empirical co-treatment for N.gonorrhoeae and C.trachomatis as symptoms overlap and co-infection is common. Studies from India estimating the same are limited and mostly based on conventional techniques. AIM AND OBJECTIVE: The aim of this study was to determine the frequency of N.gonorrhoeae and C.trachomatis coinfection using nucleic acid amplification tests. Further, we assessed the utility of pus cell estimation in Gram stained smears as a screening tool for inclusion of samples for molecular diagnosis. METHODS: This was a prospective study conducted at two tertiary care hospitals; 100 patients (55 females and 45 males) with genitourinary discharge attending STI clinics were recruited, and endocervical or urethral swabs were collected. PCRs for N.gonorrhoeae and C.trachomatis were put up. In addition, microscopy and culture for gonococcus was performed followed by antimicrobial susceptibility testing. Statistical analysis was performed using the SPSS 16 software. RESULTS: N.gonorrhoeae infection was more common than C.trachomatis. A total of 14 patients were positive by PCR (9 males and 5 females) for gonococcus. However, culture was positive only in 8 male patients. PCR for C.trachomatis was positive in 9 (4 males and 5 females) and the co-infection rate was 5%. The sensitivity and negative predictive value of pus cell estimation was 100% for males and 64% and 94.6% respectively for females. All isolates were susceptible to extended spectrum cephalosporins and azithromycin. LIMITATION: The sample size of the study was small. CONCLUSION: Frequency of N.gonorrhoeae/C.trachomatis coinfection in symptomatic STI patients is low. Coinfection is considerably overestimated and necessary confirmation of etiological diagnosis could reduce widespread empirical administration of broad-spectrum antibiotics.

Patch testing with expired Indian patch test kits: Results of a pilot study.

BACKGROUND: The reliability of patch testing with expired Indian standard patch test kits has been not evaluated before. METHODS: Thirty adults (men:women 25:5) with allergic contact dermatitis were divided into three groups of ten patients each for patch testing by Finn chamber® method using Indian standard patch test kits having expiry in 2016, 2015 and 2014. The results were compared with those from a new kit with 2018 expiry. RESULTS: Ten patients in group-1, eight patients in group-2 and seven patients in group-3 developed positive reactions of identical intensities and mostly from identical allergens from all four kits. The major contact allergens eliciting positive reactions of identical intensities were parthenium in nine, five and three patients, colophony in four, one and zero patients, fragrance mix in three, three and one patients, thiuram mix in three, one and one patients, and paraphenylene diamine in two, one and three patients from group-1,-2, and -3, respectively. LIMITATIONS: Small number of patients in each group remains the major limitation of the study. Whether or not these results can be extrapolated with patch test results from other similar patch test kits available across countries also needs confirmation. CONCLUSION: The patch test allergens can be used beyond labeled expiry dates but needs confirmation by a few large studies and using other available patch test kits. This is important as the relevance of patch test results for individual allergen in this scenario may remain debatable requiring careful interpretation.

A qualitative study on the implementation of a holistic care package for control and management of lymphoedema: experience from a pilot intervention in northern Ethiopia.

BACKGROUND: Neglected Tropical Diseases (NTDs) such as podoconiosis, lymphatic filariasis (LF) and leprosy mainly affect communities in low resource settings. These diseases are associated with physical disability due to lymphoedema as well as poor mental health and psychosocial outcomes. Integration of care across these NTDs at primary health care level, which includes mental health and psychosocial care alongside physical health care, is increasingly recommended. METHODS: A holistic integrated care package was developed and piloted as part of the EnDPoINT project in Gusha district, Awi zone, Ethiopia. The intervention was conducted at the health care organization, health facility and community levels. To assess the impact of the care package in terms of acceptability, scalability, sustainability and barriers to implementation, a qualitative study was conducted in January 2020. This included four focus group discussions (29 participants) and ten key informant interviews with decision makers, health professionals, patients, and community representatives. RESULTS: The integrated lymphoedema care package was found to be efficient compared to vertical programs in saving time and resources. It also resulted in improved awareness of the causes, treatment and prevention of lymphoedema, in marked improvements in the lymphoedema, and in reduced stigma and discrimination. The care package was found to be acceptable to patients, health professionals and decision makers. The barriers to integrated care were unrealistic patient expectations, inadequate dissemination across health workers, and poor transportation access. Health professionals, decision makers and patients believed the integrated lymphoedema care package to be scalable and sustainable. CONCLUSION: The integrated holistic care package was found to be acceptable to patients, health professionals and decision makers. We recommend its scale-up to other endemic districts.

A randomized controlled pilot study of a proprietary combination versus sunscreen in melasma maintenance.

BACKGROUND: Melasma is the commonest cause of facial hypermelanosis in skin type IV-VI. First-line treatment includes a triple combination containing topical corticosteroid and hydroquinone which have side effects on prolonged use. Chemical peels are a second-line management option with the laser being used in refractory cases, but the worsening of hyperpigmentation in darker skin types can occur following laser therapy. Sunscreen is a must to prevent relapses. AIMS AND OBJECTIVES: (i) To compare the effects of treatment with a proprietary combination (phenyl ethyl resorcinol, nonapeptide-1, aminoethyl phosphinic acid, antioxidants and sunscreen) versus sunscreen alone in limiting or reducing, melasma and preventing recurrence as a maintenance regimen after the initial use of triple combination,(ii) to evaluate the safety of the formulation studied, and (iii) to study the improvement of the quality of life of the patients after using the study formulation versus placebo. METHODS: It was a prospective double-blinded parallel-group randomized controlled pilot study. A total of 46 subjects were recruited by consecutive sampling methods and randomized to 23 each in case and control groups. The study period was eight months with three phases. Phase 1 constituted the application of triple combination for eight weeks by both groups followed by phase 2 with the case group applying proprietary medicine and the control group applying sunscreen. Phase 3 was a follow-up period to see the sustenance of results in both groups as well as any evidence of relapses. Sunscreen was applied in all three phases. RESULTS: Case group in the study showed improvement in the melasma severity score and mean melanin index as measured by mexameter but it did not attain statistical significance as compared to the control group. The melasma area and severity index score showed a consistent reduction in the case group, whereas it increased in the control group from baseline. LIMITATIONS: Small sample size and a short follow-up period of our study were major limitations. CONCLUSION: The proprietary combination, which has sunscreen as one of its constituents, is more effective in maintaining remission after triple combination without any added inconvenience of application of two separate preparations as compared to sunscreen alone.

Mycobacterium indicus pranii vaccine immunoprophylaxis in anti-phenolic glycolipid-1-positive leprosy contacts - A pilot study from a tertiary care center in North India.

BACKGROUND: Contacts of leprosy patients have an increased risk of infection with Mycobacterium leprae. Contact tracing and chemo- or immunoprophylaxis are important means of preventing leprosy transmission. AIMS: We aimed to evaluate the efficacy of immunoprophylaxis with Mycobacterium indicus pranii vaccine in reducing anti-phenolic glycolipid-1 titers in household contacts of leprosy patients. METHODS: This prospective single-center study was conducted in a tertiary care center in North India from January 2015 to December 2016. Contacts of leprosy patients (both paucibacillary and multibacillary) were screened for anti-phenolic glycolipid-1 antibodies with enzyme-linked immunosorbent assay. Those found positive were given immunoprophylaxis with a single dose of Mycobacterium indicus pranii vaccine, and anti-phenolic glycolipid-1 titers were evaluated at six and 12 months. All contacts were clinically followed for three years. RESULTS: Of the 135 contacts of 98 leprosy patients that were screened, 128 were recruited. Seventeen of these contacts were positive for anti-phenolic glycolipid-1 antibodies and were given Mycobacterium indicus pranii vaccine. Two contacts were lost to follow-up. After immunoprophylaxis, anti-phenolic glycolipid-1 titers were negative in all patients at all intervals, and no contact developed any clinical signs or symptoms of leprosy during the three-year follow-up. LIMITATIONS: The small number of contacts studied, the short follow-up period and the absence of a control group were limitations of this study. Dicussion: We could not find any papers on natural decline of PGL 1 titres in contacts, although in leprosy patients, these titres may even increase after completion of treatment. However the titres do correlate with bacterial load (reference: Int J Lepr Other Mycobact Dis. 1998 Sep;66(3):356-64) so if the tires decrease or become negative it may be considered as an indirect evidence of bacillary clearance. Hence we may suggest the protective efficacy. Furthermore, as the editor mentioned, considering the small number of positive patients, a control group was not possible in the present pilot study, but such studies may be carried out in the future. CONCLUSION: Immunoprophylaxis with Mycobacterium indicus pranii vaccine is effective and safe in preventing disease in contacts of leprosy patients. However, these findings need to be replicated in larger studies.

Strengthening individual and family resilience against leprosy-related discrimination: A pilot intervention study.

BACKGROUND: Leprosy and leprosy-related stigma can have a major impact on psychosocial wellbeing of persons affected and their family members. Resilience is a process that incorporates many of the core skills and abilities which may enable people to address stigma and discrimination. The current study aimed to develop and pilot an intervention to strengthen individual and family resilience against leprosy-related discrimination. METHODOLOGY: We used a quasi-experimental, before-after study design with a mixed methods approach. The 10-week family-based intervention was designed to strengthen the resilience of individuals and families by enhancing their protective abilities and capacity to overcome adversity. The study was conducted in two sites, urban areas in Telangana state, and in rural areas in Odisha state, India. Persons affected and their family members were included using purposive sampling. Two questionnaires were used pre-and post-intervention: the Connor-Davidson Resilience Scale (CD-RISC, maximum score 100, with high scores reflecting greater resilience) and the WHOQOL-BREF (maximum score of 130, with higher scores reflecting higher quality of life). In addition, semi-structured interviews were conducted post-intervention. Data were collected at baseline, a few weeks after completion of the intervention, and in the Odisha cohort again at six months after completion. Paired t-tests measured differences pre- and post- intervention. Qualitative data were thematically analysed. FINDINGS: Eighty participants across 20 families were included in the study (23 persons affected and 57 family members). We found a significant increase in CD-RISC scores for persons affected and family members from Odisha state (baseline 46.5, first follow-up 77.0, second follow-up 70.0), this improvement was maintained at six-month follow-up. There was no increase in CD-RISC scores post-intervention among participants from Telangana state. WHOQOL-BREF scores were significantly higher at follow-up for persons affected in both states, and for family members in Odisha state. No families dropped out of the study. In the qualitative feedback, all participants described drawing benefit from the programme. Participants especially appreciated the social dimensions of the intervention. CONCLUSION: This pilot study showed that the 10-week family-based intervention to strengthen resilience among persons affected by leprosy and their family members was feasible, and has the potential to improve resilience and quality of life. A large-scale efficacy trial is necessary to determine the effectiveness and long-term sustainability of the intervention.

A family-based intervention for prevention and self-management of disabilities due to leprosy, podoconiosis and lymphatic filariasis in Ethiopia: A proof of concept study.

A key issue for persons with leprosy-, lymphatic filariasis- and podoconiosis-related disabilities is the life-long need to practice self-management routines. This is difficult to sustain without regular encouragement and support of others. Family-based support may be a sustainable and feasible strategy to practice self-management routines. This proof of concept study aimed to develop and pilot a family-based intervention to support prevention and self-management of leprosy, lymphatic filariasis and podoconiosis-related disabilities in Ethiopia. We used a quasi-experimental pre/post intervention study design with a mixed methods approach. The study population included persons affected by leprosy, lymphatic filariasis and podoconiosis and their family members. All persons affected had visible impairments due to their condition. We collected physical impairment outcomes, data on activity limitations, stigma and family quality of life using the SALSA scale (range 0-80), the SARI stigma scale (range 0-63) and the Beach Centre Family Quality of Life scale (range 0-125) and conducted in-depth interviews and focus group discussions. Quantitative data were analysed using paired t-tests, unequal variances t-tests, linear regression and binary logistic regression. Qualitative data were coded using open, inductive coding and content analysis. The family-based intervention consisted of self-management of disabilities, awareness raising and socio-economic empowerment. The intervention was delivered over several monthly group meetings over the course of several months. A total of 275 (100%) persons affected attended at least one session with a family member, and 215 (78%) attended at least three sessions. There was no significant improvement in eye and hand problems after the intervention. However, foot and leg impairments, number of acute attacks, lymphedema and shoe wearing all significantly improved at follow-up. In addition, family quality of life significantly improved from 67.4 at baseline to 89.9 at follow-up for family members and from 76.9 to 84.1 for persons affected (p<0.001). Stigma levels significantly decreased from 24.0 at baseline to 16.7 at follow-up (p<0.001). Activity levels improved, but not significantly. This proof of concept study showed that the family-based intervention had a positive effect on impairments and self-management of disabilities, family quality of life and stigma. We recommend a large-scale efficacy trial, using a randomised controlled trial and validated measurement tools, to determine its effectiveness and long-term sustainability.

Thymocyte selection-associated high-mobility group box as a potential diagnostic marker differentiating hypopigmented mycosis fungoides from early vitiligo: A pilot study.

BACKGROUND: Hypopigmented mycosis fungoides is a rare variant of mycosis fungoides that may mimic many benign inflammatory hypopigmented dermatoses, and as yet there is no identified marker to differentiate between them. AIM: The aim of this study was to study the expression of thymocyte selection-associated high-mobility group box (TOX) in hypopigmented mycosis fungoides and one of its inflammatory mimickers (early active vitiligo) to assess its potential as a differentiating diagnostic marker. METHODS: A case-control study was done using immunohistochemical analysis of TOX expression in 15 patients with hypopigmented mycosis fungoides and 15 patients with early active vitiligo. Immunohistochemical analysis was done via a semi-quantitative method and an image analysis method. RESULTS: Hypopigmented mycosis fungoides showed a statistically significant higher expression of TOX than early active vitiligo. The expression of TOX was positive in a majority of hypopigmented mycosis fungoides cases (14 cases, 93.3%), while only one case (6.7%) of vitiligo was weakly positive. TOX also displayed 93.3% sensitivity and specificity, with a cut-off value of 1.5. LIMITATIONS: This was a pilot study testing hypopigmented mycosis fungoides against only a single benign inflammatory mimicker (early vitiligo). Other benign mimickers were not included. CONCLUSION: Our findings showed that TOX expression can differentiate hypopigmented mycosis fungoides from early active vitiligo which is one of its benign inflammatory mimickers, with a high degree of sensitivity and specificity.

A Hand-Held Ultrasound Device for the Assessment of Peripheral Nerves in Leprosy.

BACKGROUND AND PURPOSE: Mycobacterium leprae complex affects peripheral nerves, causing nerve enlargement. This proof-of-concept pilot study was conducted to determine if a small hand-held ultrasound device can accurately identify nerve involvement in individuals with leprosy. METHODS: Peripheral nerve ultrasound was conducted of the bilateral median (wrist, forearm, elbow, and mid-humerus), ulnar (wrist, forearm, elbow, 4 cm proximal to the elbow, and mid-humerus), C5 root, and greater auricular nerves with a standard ultrasound device (15 Mhz) and a hand-held ultrasound device (5 MHz). Nerve cross-sectional areas were compared using the two devices. RESULTS: Eight individuals with leprosy were examined. Strong correlation was found between the standard and hand-held ultrasound devices (r = .76, P < .001). A certain amount of variability between ultrasound devices may occur for multiple reasons. CONCLUSION: A hand-held ultrasound device can readily identify nerve enlargement in individuals with leprosy. This type of device may assist in the diagnosis of leprosy in areas with limited healthcare resources because of the portability and low-cost nature of such devices.

Mobile Health Strategies to Tackle Skin Neglected Tropical Diseases With Recommendations From Innovative Experiences: Systematic Review.

BACKGROUND: Neglected tropical diseases (NTDs) represent a diverse group of 20 communicable diseases that occur in tropical and subtropical areas in 149 countries, affecting over 1 billion people and costing developing economies billions of dollars every year. Within these diseases, those that present lesions on the skin surface are classified as skin NTDs (sNTDs). Mobile health interventions are currently being used worldwide to manage skin diseases and can be a good strategy in the epidemiological and clinical management of sNTDs. OBJECTIVE: We aimed to analyze existing evidence about mobile health interventions to control and manage sNTDs in low- and middle-income countries (LMICs) and make recommendations for what should be considered in future interventions. METHODS: A systematic review was conducted of the MEDLINE, Embase, and Scopus databases over 10 years up to April 30, 2020. All types of clinical studies were considered. Data were synthesized into evidence tables. Apps were selected through a comprehensive systematic search in the Google Play Store and Apple App Store conducted between March 20 and April 15, 2020. RESULTS: From 133 potentially relevant publications, 13 studies met our criteria (9.8%). These analyzed eight different interventions (three SMS text messaging interventions and five app interventions). Six of the 13 (46%) studies were community-based cross-sectional studies intended to epidemiologically map a specific disease, mainly lymphatic filariasis, but also cutaneous leishmaniasis, leprosy, and NTDs, as well as sNTDs in general. Most of the studies were considered to have a high (5/13, 39%) or moderate (4/13, 31%) risk of bias. Fifteen apps were identified in the Google Play Store, of which three were also in the Apple App Store. Most of the apps (11/15, 73%) were targeted at health care professionals, with only four targeted at patients. The apps focused on scabies (3/15, 20%), lymphatic filariasis (3/15, 20%), cutaneous leishmaniasis (1/15, 7%), leprosy (1/15, 7%), yaws and Buruli ulcer (1/15, 7%), tropical diseases including more than one sNTDs (3/15, 20%), and NTDs including sNTDs (2/15, 13%). Only 1 (7%) app focused on the clinical management of sNTDs. CONCLUSIONS: All mobile health interventions that were identified face technological, legal, final user, and organizational issues. There was a remarkable heterogeneity among studies, and the majority had methodological limitations that leave considerable room for improvement. Based on existing evidence, eight recommendations have been made for future interventions.

EnDPoINT: protocol for an implementation research study to integrate a holistic package of physical health, mental health and psychosocial care for podoconiosis, lymphatic filariasis and leprosy into routine health services in Ethiopia.

INTRODUCTION: Neglected tropical diseases (NTDs) causing lower limb lymphoedema such as podoconiosis, lymphatic filariasis (LF) and leprosy are common in Ethiopia. Routine health services for morbidity management and disability prevention (MMDP) of lymphoedema caused by these conditions are still lacking, even though it imposes a huge burden on affected individuals and their communities in terms of physical and mental health, and psychosocial and economic outcomes. This calls for an integrated, holistic approach to MMDP across these three diseases. METHODS AND ANALYSIS: The 'Excellence in Disability Prevention Integrated across NTDs' (EnDPoINT) implementation research study aims to assess the integration and scale-up of a holistic package of care-including physical health, mental health and psychosocial care-into routine health services for people with lymphoedema caused by podoconiosis, LF and leprosy in selected districts in Awi zone in the North-West of Ethiopia. The study is being carried out over three phases using a wide range of mixed methodologies. Phase 1 involves the development of a comprehensive holistic care package and strategies for its integration into the routine health services across the three diseases, and to examine the factors that influence integration and the roles of key health system actors. Phase 2 involves a pilot study conducted in one subdistrict in Awi zone, to establish the care package's adoption, feasibility, acceptability, fidelity, potential effectiveness, its readiness for scale-up, costs of the interventions and the suitability of the training and training materials. Phase 3 involves scale-up of the care package in three whole districts, as well as its evaluation in regard to coverage, implementation, clinical (physical health, mental health and psychosocial) and economic outcomes. ETHICS AND DISSEMINATION: Ethics approval for the study has been obtained in the UK and Ethiopia. The results will be disseminated through publications in scientific journals, conference presentations, policy briefs and workshops.

Nutritional status and morbidity profile of children with leprosy contact in a rural community.

An observational pilot study was conducted to assess the nutritional status and morbidity profile of childhood contacts of leprosy in an endemic area (Chengalpattu) in India. A total of 70 such children were included in the study. Sociodemographic data were collected using a one-to-one interview method and the children were evaluated by dermatologists qualified in paediatric leprosy. The obtained data were computed. Three children were diagnosed to have leprosy through this study. Nutritional status assessment in these children demonstrated malnutrition, a common finding. Regular contact screening of children in endemic areas for early case detection, disability prevention and thereby prevention of community transmission is mandatory. Further research is needed concerning the role of malnutrition in children and its relation to morbidity in leprosy. The closeness and duration of contact of leprosy is also an important risk factor. Effective strategies to diagnose subclinical infection are needed.