Health Condition 1: null- Diagnosis of scabies characterized by having Burrows, Scabetic Lesions, and Noctural Pruritus
Conditions
Interventions
Intervention1: Permethrin 5% Cream, Zydus Worldwide DMCC, United Arab Emirates: 15 gm for children and 30 gm for adults.
Single application, Topical cream
Control Intervention1: Elimite® (Permethrin
Sponsors
Zydus Worldwide DMCC UAE
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-lactating female aged 5 - 65 years (inclusive both) in good general health. 2. The diagnosis of scabies as demonstrated by presence of eggs, larva, mites/mite products or fecal pellets by dermatoscopy/microscopy of skin scraping. 3. Presence of Atleast Three of the following clinical criteria (a) demonstration of burrow; (b) presence of scabetic lesions at the classical sites; (c) nocturnal pruritus; (d) Family history of similar illness. 4. Willing to refrain from use of other topical medications or anti-scabetic agents during the 4 week study period. 5. No history of chronic or recurrent dermatological disease. 6. If female of childbearing potential, willing to use an acceptable form of birth control during the study. 7. Able to comply with the study requirements and procedures as per protocol. 8. Willing to provide written informed consent or assent (as applicable).
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women or women of child bearing potential planning to become pregnant during the study period. 2. Patients with known hypersensitivity to study drugs or any of its components. 3. Patients with a history of treatment with any anti-scabetic or topical steroid in the previous 4 weeks. 4. Patients with signs of systemic infections; or scabies with atypical presentations like crusted scabies or scabies incognito. 5. Patients with heavily crusted or nodular lesions, secondary infection or eczematization and coexisting dermatological disease that could interfere with the diagnosis and subsequent monitoring of scabies. 6. History of any significant cardiovascular, hepatic, renal, pulmonary, haematologic, gastrointestinal, endocrine, immunologic, musculoskeletal psychiatric disease, or malignancies which in the opinion of the investigator, may compromise patient safety. 7. History of uncontrolled diabetes mellitus, hypertension, or chronic infectious diseases. 8. Patients consuming tobacco in any form, alcohol, or any substance of abuse. 9. Known/suspected immunocompromised individuals. 10. Participation in any other clinical study within 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Endpoint Proportion of patients clinically cured at End of study Day 28 plus 03 defined as subject either Cured or Improved At day 28 plus 3 patients will be classified as Cured if all original primary lesions have healed Improved if original primary lesions are healing but persist Not cured if no improvement is noted Safety Endpoint Adverse events Application site reactions Timepoint: At 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in severity score of scabies at End of study â?¢ Proportion of patients with microbiological cure at End of study Proportion of patients with therapeutic cure Proportion of patients with persistence of pruritus at End of study The subjective assessment of pruritus will be doneTimepoint: Day 14 and 28 | — |
Countries
India
Contacts
Public ContactMr Vidhu Shekhar Mishra
Cliantha Research Limited,
Outcome results
None listed