Effectiveness and Safety of Spinosad 0.9 Percent Topical Solution vs Permethrin 5 Percent Topical Solution in the Treatment of Scabies: A Prospective, Comparative, Two arm, Double blind, Randomized Controlled Study at a Tertiary Care Centre in Mandya.
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Proportion of subjects within each treatment group showing complete clinical cure defined as reduction in both the number of lesions as well as the grade of pruritus by more than or equal to 50% and negative dermatoscopy.
Overview
Brief Summary
This study is a prospective, double-blind, randomized controlled trial comparing Spinosad 0.9% topical solution and Permethrin 5% cream in the treatment of scabies.
A total of 60 patients with clinically and dermatoscopically confirmed scabies will be enrolled and randomly allocated into two groups.
Each participant will receive a single application of either Spinosad or Permethrin, with follow-up assessments at 1, 2, and 4 weeks.
Effectiveness will be measured by reduction in lesions, pruritus severity, and dermatoscopic cure, while safety will be monitored through adverse events.
The primary objective is to compare complete clinical cure rates between the two drugs.
The findings aim to provide evidence on whether Spinosad can serve as an effective and safe alternative to Permethrin in routine scabies management.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 5.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients aged 5 years or older, either gender with active scabies infestation showing the presence of scabies inflammatory lesions (papules, pustules, vesicles, excoriations), pruritus and confirmed with burrows or mite or eggs in dermatoscopy.
- •Patient (or their legal guardians) are willing to give the informed consent/ assent to participate in the study.
Exclusion Criteria
- •Pretreatment with topical or oral scabicide in the previous 4 weeks.
- •Use of topical steroids or topical immunosuppressives within 2 weeks.
- •Patients having scabies with secondary infection or eczematization and coexisting dermatological disease that could interfere with the diagnosis and subsequent monitoring of scabies.
- •Patients with immunodeficiency or severe systemic disease.
- •Pregnant, planning for pregnancy during the study and lactating females.
- •Patients with known hypersensitivity to the drugs.
Outcomes
Primary Outcomes
Proportion of subjects within each treatment group showing complete clinical cure defined as reduction in both the number of lesions as well as the grade of pruritus by more than or equal to 50% and negative dermatoscopy.
Time Frame: Dat 14
Secondary Outcomes
- Proportion of patients showing reduced number of lesions/ symptoms.(Proportion of patients showing recurrence of lesions)
Investigators
Dr Deepadarshan K
Mandya Institute Of Medical Sciences