Three Arm Clinical Study to Compare the Efficacy and Safety of Test formulations of Permethrin in adults with scabies
- Conditions
- Health Condition 1: null- Patients with Scabies.
- Registration Number
- CTRI/2018/01/011266
- Lead Sponsor
- Glasshouse Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.The diagnosis of scabies as demonstrated by presence of eggs, larva, mites/mite products or fecal pellets by dermatoscopy/microscopy of skin scraping.
2.Presence of At least 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.
3.Willing to refrain from use of other topical medications or anti-scabetic agents during the 4 week study period.
4.No history of chronic or recurrent dermatological disease.
5.If female of childbearing potential, willing to use an acceptable form of birth control [Intrauterine device in place or Oral contraceptives for at least 2 months prior to the start of the study and remaining in place during the study period, or Barrier methods containing or used in conjunction with a spermicidal agent, or Practicing sexual abstinence throughout the course of the study] during the study.
1.Pregnant or lactating women or women of child bearing potential planning to become pregnant during the study period.
2.Subjects with known hypersensitivity to study drugs or any of its components.
3.Subjects with a history of treatment with any anti-scabetic or topical steroid in the previous 4 weeks.
4. Subjects with signs of systemic infections; or scabies with atypical presentations like crusted scabies or scabies incognito.
5. Subjects with severe cutaneous bacterial or fungal infections requiring therapy (including systemic and topical antibiotics).
6. Use of prohibited medications:
(a) Any anti-scabetic agent
(b) Topical or oral scabicidal/antiparasitic treatment including:
Permethrin (except study medication), benzyl alcohol, benzyl benzoate,
lindane, crotamiton, malathion, ivermectin, precipitated sulfur,
albendazole, keratolytic cream, tea tree oil, or oil of the leaves of
Lippia multiflora Moldenke within 28 days of baseline visit.
(c) Systemic corticosteroids (including inhaled steroids) taken within 14
days of baseline visit.
(d) Topical corticosteroids including hydrocortisone taken within 24 hours
of baseline visit.
(e) Topical antipruritics, including antihistamines within 24 hours of any
study visits.
(f) Oral antihistamine including diphenhydramine taken within 24 hours of
any study visits.
(g) Topical antibiotics including mupirocin taken within 24 hours of any
study visits.
7. Subjects 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.
8. 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 subject safety.
9. History of uncontrolled diabetes mellitus, hypertension (systolic BP more than or equal to 150 mmHg/diastolic BP more than or equal to 100 mmHg), or chronic infectious diseases.
10.Subjects consuming tobacco in any form, alcohol, or any substance of abuse.
11.Known/suspected immune compromised individuals.
12.Participation in any other clinical study within 30 days prior to screening.
13.Any reason which, in the opinion of the Principal Investigator or Co- Investigator, would prevent the subject from safely participating in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects clinically curedTimepoint: Day 14 and Day 28
- Secondary Outcome Measures
Name Time Method Primary Endpoint- <br/ ><br>Mean change in severity score of scabies at End of study <br/ ><br> <br/ ><br>Secondary Endpoint â?? <br/ ><br> <br/ ><br>(a) Mean change in severity score of scabies at End of study (Day 28 plus or minus 04) <br/ ><br> <br/ ><br>(b) Proportion of subjects with microbiological cure,persistence of pruritus at End of study (Day 28 plus or minus 04). <br/ ><br> <br/ ><br>(c) Proportion of subjects with therapeutic cure (microbiological cure plus clinical cure <br/ ><br> <br/ ><br>(d) Proportion of patients who required additional second dose of treatment.Timepoint: Day 14 and Day 28