Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Permethrin 5.0% w/w Cream: Permethrin 30 gm tube applied topically once on dry and cool body surface once at time of recruitment.
Control Intervention1: Permethrin 5.0% w/w Cream: Perme
Sponsors
Morningside Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject is in good general health with normal appearing skin in non infected areas. 2.Subject is in good general health with normal appearing skin in non infected areas. 3.Clinical findings typical of scabies (burrows, erythematous papules, etc.) and microscopic confirmation of scabies mite, ova, or mite feces at classical sites. 4.Subject is able to provide written informed consent prior to study. 5.Willingness to comply with the study schedule and procedures.
Exclusion criteria
Exclusion criteria: 1.Subjects with any condition which in opinion of the investigator makes the subject unsuitable for inclusion. 2.Skin conditions that could make it difficult to evaluate the extent of an infestation or would present a problem in the evaluation of response to therapy (e.g. atopic dermatitis, eczema, contact dermatitis, lichen planus, papular urticaria, seborrheic dermatitis). 3.Subjects used following within 4 weeks of baseline visit 1 immunomodulators 2 systemic medications that suppress the immune system 3 topical or oral parasiticides. 4.Subject used following within 2 weeks of baseline visit (1) topical steroids (2) topical or systemic antibiotics. 5.Subject has crusted scabies. 6.Subject with known history of irritation or sensitivity to parasiticides. 7.Known allergy or hypersensitivity to permethrin, any synthetic pyrethroid or pyrethrin, plants in the Asteraceae/Compositae family (e.g. chrysanthemums, ragweed, marigolds, and daisies). 8.Subjects whose household members and close contacts refuse treatment. 9.Subjects whose sexual contacts do not agree to restrict prolonged skin to skin contact with non-household members during the study period. 10.Subjects with a household member less than 2 months of age. 11.Subject with signs of systemic infection or is receiving systemic therapy for an infectious disease. 12.Subjects with secondary bacterial infection based on subjective evidence. 13.Subjects with skin wounds, open injuries or other conditions of broken skin at the site of proposed application. 14.Subjects with history of severe cardiac, central nervous system, immunodeficiency, diabetes mellitus, hepatic, gastrointestinal, renal, pulmonary and skin diseases. 15.Subject is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding. 16.Participation in any other clinical trial during last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Proportion of responder during the 28 days will be compared between treatments. The responder will be defined as patients with no scabies remaining and at least 50% improvement in the VAS score for pruritus.Timepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Dermoscopy & confirmation of absence of mites, eggs/ova and/or mite feces by Microscopy. Reported reduction or absence of pruritus (itching). Clinical visual reduction or absence of scabietic lesions. Percentage reduction in VAS scores for pruritus.Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactDr Milan Satia
Ethicare Clinical Trial Services
Outcome results
None listed