Comparison of Permethrin and Ivermectin in Children Greater Than 6 Yrs Age for Treatment of Scabies (not existed)

Children Hospital and Institute of Child Health, Lahore

Status and phase: Begins enrollment this month; Phase 2

Conditions: Scabies

Treatments: Drug: Permethrin Cream, 5%; Drug: Ivermectin 200 µg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT06896929

715-24-10-2023ApprovedbyCHUCHS

Details and patient eligibility

About

Scabies is highly contagious,pruritic infestation of skin.Various treatment modalities have been used but search for ideal scabicide is ongoing.we wnt to coduct this study to compare the outcome of permethrin verses ivermectin in children for treatment of scabies .This randomized clinical trial will be done in children hospital lahore for 12 months.Sample size of 90 cases;30 in each group will be included through non probability consecutive sampling.Then patient will be randomly divided into 3 groups.In group A patient will be given 5% permethrin topical application to whole body single application. In Group B ,patients will be given topical permethrin for twice application 24 hrs appart ,In group C patients will be given Tablet Ivermectin single dose 200microgram/kg.Then patients will be examined after 2 weeks and 4 weeks for no of lesions and pruritis and cure will be labeled.All this information will be recorded on performa .Data will be entered and analysed by using SPSS version 26.Three groups will be compared for cure by using chi-square test.P value less than and equal to 0.05 will be considered as significant.

Enrollment: 90 estimated patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 6-15
• Both genders
• Diagnosed with scabies (as per operational definition)

Exclusion criteria

• Children with recurrent scabies on medical record
• Known allergy to ivermectin or permethrin.
• Widespread eczema or impetigo.
• Liver dysfunction or renal failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Group A

Experimental group

Description:

Group A will be given Permethrin

Treatment:

Drug: Permethrin Cream, 5%

Drug: Permethrin Cream, 5%

Group B

Experimental group

Description:

Group B will be given Permethrin 5% cream twice application

Treatment:

Drug: Permethrin Cream, 5%

Drug: Permethrin Cream, 5%

Group C

Experimental group

Description:

Group C will be given Tab Ivermectin

Treatment:

Drug: Ivermectin 200 µg/kg