A PROSPECTIVE, RANDOMIZED, OPEN LABEL STUDY ON EFFICACY, SAFETY AND TOLERABILITY OF TOPICAL PERMETHRIN 5 PERCENTAGE VS TOPICAL SPINOSAD 0.9 PERCENTAGE IN MANAGEMENT OF SCABIES
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Dr.Noorain Hamid Khan
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- To assess the clinical efficacy of topical permethrin 5% vs topical spinosad 0.9% in management of scabies
Overview
Brief Summary
Scabies is a contagious parasitic infestation of the skin caused by the itch mite Sarcoptes scabiei var.hominis. There are various treatment options available. This is a prospective, randomized open label clinical study to assess the efficacy, safety, and tolerability of topical permethrin 5% vs topical Spinosad 0.9% in the management of scabies. Each group will have 48 patients each. Group A will include patients who will be treated with topical permethrin 5% cream applied locally 8 hours overnight from the neck down, followed by shower the next morning and then repeat in 1 week. Group B will include patients who will be treated with topical Spinosad 0.9% cream applied locally 8 hours overnight from the neck down followed by shower the next morning. Both the groups will be followed up for 4 more weeks thus total duration will be of 6 weeks. Thus the study aims to find the best possible results in management of scabies.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 4.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients who are clinically diagnosed case of scabies.
- •Household contacts of the patients.
- •Age include Above 4 years and less than 65 years.
- •Both sexes.
- •Complaint of nocturnal pruritus and papules or excoriation marks over the body.
- •Patient having typical burrows over the web spaces and involvement of flexures of upper limb, axilla, breast, and groins.
Exclusion Criteria
- •Age less than 4 years, pregnancy, those females planning for pregnancy in next one month and lactation.
- •Atypical variant and scabies with secondary infection.
- •H/O recent live vaccination, other scabicide drugs taken in recent past.
- •Patients with anemia, liver diseases, kidney disease.
- •Patients with malignancies or lymphoproliferative disorders.
- •Patients on potent immunosuppresants, immunocompromised individuals.
- •Family history of melanoma or non melanoma skin cancers.
- •Patients unwilling to participate in the study.
Outcomes
Primary Outcomes
To assess the clinical efficacy of topical permethrin 5% vs topical spinosad 0.9% in management of scabies
Time Frame: Baseline, Week One, Week Two, Week Four, Week six
Secondary Outcomes
- To assess the safety and tolerability of topical permethrin 5% vs topical spinosad 0.9% in management of scabies(6 weeks)
Investigators
DrNoorain Hamid Khan
Shri Bhausaheb Hire Government Medical College