View clinical trials related to Scabies.
Filter by:The EPIC-15 trial will evaluate the safety, pharmacokinetics, acceptability, and efficacy of pediatric ivermectin (CHILD-IVITAB) in scabies infected children weighing 5 to less than 15 kg. This trial will support future efforts to expand the indication of ivermectin treatment to infants weighing 5 to less than 15 kg to treat numerous NTDs, allowing this young age group equitable access to the numerous benefits of pediatric ivermectin therapy
In 2017, the World Health Organization (WHO) labeled scabies as a neglected tropical disease. It is a serious health problem especially in poor developing countries like Syria, where overcrowding, poverty, and war consequences are considered major factors for spreading the disease. Permethrin lotion or cream is the treatment of choice for scabies, and it is applied once a week for two consecutive weeks according to the global guidelines. However, most practitioners in Syria do not adhere to this standard regimen, and a variety of regimens are used instead based mostly on clinical experience. In this study, the investigators are comparing four different regimens of permethrin application and comparing Sulfur to permethrin in terms of efficacy and safety.
The multi-center, prospective, randomized, double-blind phase III clinical trial will primarily investigate the efficacy and safety of treatment of scabies with Permethrin Cream 5% (approved drug InfectoScab 5% Cream) in direct comparison with Permethrin Cream 10%. The trial participants will be randomly assigned and blinded to either Permethrin Cream 5% or Permethrin Cream 10%.
Moxidectin is not approved to treat scabies in humans. The effective dose of moxidectin to treat scabies is not known. This study aims to assess the efficacy of a single administration of 8 mg, 16 mg, or 32 mg moxidectin per oral in achieving Scabies Complete Cure at Day 28. This study also aims to assess the safety of three strengths of single moxidectin doses in adults with scabies.
Sarcoptes scabiei is responsible for a skin infection called scabies. Permethrin is most widely used anti-scabicidel drug and is taken as drug of choice because of its efficacy, safety and patient's compliance. Sulfur 6-33%, as cream, ointment or lotion, is recommended by the European guidelines as an effective alternative treatment and is among the oldest treatments used for scabies. It is recommended to be applied for 3 consecutive days. Both permethrin and sulfur have been shown in previous studies to be superior to other anti-scabietic drugs in terms of efficacy. Two studies showed that permethrin was more efficacious than sulfur, whereas a single study showed otherwise. Therefore, only a few studies are available to find a direct comparison of the efficacy of topical 5% permethrin and topical 10% sulfur in the treatment of scabies and none of them have been carried out in Pakistan. The objective of the study is to compare the efficacy of topical 5% permethrin cream and sulfur 10% ointment in the treatment of scabies.
Scabies is a skin disease characterized by intense itching that worsens at night. It is very contagious, still has a high occurrence rate, and impacts patient quality of life. The use of scabicide followed by a clean and healthy lifestyle is the principle of scabies therapy. The primary treatment option for scabies is permethrin 5% cream. Ivermectin is an alternate treatment for scabies.
This is an open label prospective pharmacokinetic single arm study in Laos PDR. This study will be embedded within a cluster-randomized controlled trial of interventions to address childhood undernutrition (SUANHOAM Trial, ACTRN12620000520932) and involves a collaboration with the Murdoch Children's Research Institute, Burnet institute and Lao Tropical and Public Health Institute. ITCHY Study: The primary objective is to determine in young children aged 2 to <5 years and weighing 10 to <15 kg if an ivermectin dose of 3 mg achieves comparable drug exposures to the recommended dose in older children. It aims to provide reliable evidence for a safe and effective dose of ivermectin in young children who are especially vulnerable to scabies infections and the associated secondary complications. ITCHY2 Study: An embedded phase 2 multicentre, open label prospective pharmacokinetic study in Laos PDR of ITCHY Study. The primary objective is to determine the plasma ivermectin drug exposure in children aged 3 months to 2 years and weighing ≥2 kg receiving an age specific ivermectin dose.
Globally, Scabies infects 300m people each year. In children of developing countries, its prevalence is expected to be about 5 to 10%.In Pakistan, Scabies accounts for 38% of dermatological diseases. Males were more prone to infestation than females, and early school-aged children were the most vulnerable. It was more widespread in urban than in rural areas. A distinct seasonal pattern emerged, with the biggest infestation occurring in the winter and the lowest in the summer. Scabies risk factors estimated 89% of the variation in its prevalence. The classic scabies symptoms include an erythematous papular eruption, burrows, and intense itching. It is usually transmitted by prolonged skin-skin contact. Predilection sites are fingers, axilla, elbows, waist, belly, groin, genital area, etc. Classic scabies can be diagnosed by proper taking history and clinical symptoms. Some of the clinical variations of scabies are Crusted, nodular, and bullous. On examination under a microscope of scrapings collected from skin lesions, finding the mites, eggs, confirms the infestation of scabies . Topical permethrin and oral ivermectin are the medications of choice for scabies mite elimination. Topical Permethrin 5% applied for 9-14 hours for adults than for children only 8-9 hours. Permethrin 5% only single dose is enough but the second dose can be applied after an interval of 2 weeks if the etiology is still there. Ivermectin is now used to treat scabies, with an effective dosage of 150 to 200 μg/kg given once or may give twice after interval of two weeks. The positives include a single dosage and improved compliance in resistant infestations and situations where head-to-toe topical administration is logistically problematic, such as huge outbreaks or mentally impaired individuals. Fever, arthralgia, myalgia, dizziness, headache, hypotension, tachycardia, and lymphadenopathy have all been reported as adverse effects. There have also been reports of a prolonged prothrombin time, a transient EKG, and variations in liver enzymes. The study's implications are to analyze the safety and efficacy of these two drugs in order to better treat patients with evidence-based management and rule out any potential adverse effects.
A population of approximately 50 pediatric subjects will be enrolled to assess the PK of spinosad and benzyl alcohol for 3 hours following a single, full-body topical application (open label) on a single in-clinic visit (Day 1, or Day 2 if screening only on Day 1). There will be approximately 50 subjects ages 1 month to 3 years 11 months of age enrolled with the goal of completing approximately 16 subjects. With assistance from a caregiver, Natroba will be applied over the entire body from the neck down to the toes (including the soles of the feet) and to the hairline, temples, forehead and possibly the scalp (if a scabies infestation is present on the scalp). The open-label Investigational Product (IP) will remain on the skin for at least 6 hours before removing the IP by gentle washing. The subjects will stay in the clinic until the 3-hour procedures are completed. Blood draws will be taken at 0 hours just prior to treatment, and then at 0.5 and 3.0 hours post-treatment. Heel sticks are likely to be the mode of blood collection for children less than 2 years of age. A ±5-minute time window will be allowed for all post-treatment blood samples. Removal of IP can occur by the caregiver at home after it has been on the skin for at least 6 hours before bathing the child. Safety will be assessed with adverse events (AEs), general skin and eye irritation assessments, and pre-dose and pre-discharge laboratory evaluations. Following the sample collections subjects will be released from the clinic and directed to their primary care physician for follow-up. Subjects will be provided scabies medications upon discharge to dispense to family members. These include 5% Permethrin for those in the household that are less than 4 years of age and Natroba for those in the household 4 years of age and older. Subjects who terminate early will not be given these medications to dispense to family members.
Scabies is a parasitic pathology contracted mainly through human contamination. It is caused by a parasite (Sarcoptes Scabiei var. hominis) which lodges into the top layer of the epidermis creating a burrow, which can measure 5 mm to 15 mm, where the female lays her eggs. After 4-6 weeks the patient develops an allergic reaction to the presence of mite proteins and feces in the scabies burrow, causing intense itch and rash. The usual adult form, called common scabies, is characterized by this nocturnal pruritus, and typical and/or atypical lesions. The typical lesions are the vesicle (translucent vesicle on an erythematous base), the scabious burrow (due to the tunnel dug by the female in the stratum), and the papulo- nodule -nodular scabious (red/brown infiltrated on palpation, predominantly on the male genital areas). They predominate in certain regions: the interdigital region of the hands, the anterior face of the wrists, the external face of the elbows, the axillary region, the areolas, the nipples, the umbilical region, the male external genitalia, the buttock region, the face inner thighs. Scabies occurs worldwide. However, studies have shown a greater prevalence among populations that do not have access to common hygiene measures: poor, young children and elderly in resource -poor communities, migrant, homeless populations, etc. The "Baudelaire outpatient clinic" (BOPC) at St Antoine hospital in Paris offers general medicine consultations. It has the particularity of offering a so called "Permanent d'Accès Aux Soins" service that allowed any person without health assurance to have access to a general practitioner and treatment, free of charge and help to recover its social rights. Consequently, more than 60% of the patients encountered at the consultation of the BOPC are in a precarious situation. Usually, poor patients with scabies may be offered a shower and clean clothes at the BOPC Therefore it seemed to us the ideal place to evaluate a treatment's scabies in this population including the hygiene treatment.