A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of Scabies

Launched by DR. REDDY'S LABORATORIES LIMITED · Oct 8, 2015

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Signed Informed Consent that meets all criteria of current FDA regulations.
• • 2. Male or non-pregnant, non-lactating female at least 2 years of age or older.
• • 3. Diagnosis of active scabies by presence of a burrow and/or typical scabietic lesions at the classic sites of infestation.
• • 4. Parasitological confirmation of clinical diagnosis with demonstration under light microscope of mites and/or their products (larvae, eggs or fecal material).
• • 5. Symptom score of 2 or 3 on a 4-point rating scale of 0-3 for nocturnal itching.
• 6. Women must be either 1 year post-menopausal (no menstrual periods for at least 12 months), surgically sterile, or if they are of child-bearing potential, they must:
• • Have been using systemic birth control, intrauterine device, or used barrier methods such as diaphragm plus spermicide or condom plus spermicide consistently, at least 14 days before study cream administration.
• • Had a normal menstrual cycle for the month before start of treatment.
• • Have a negative urine pregnancy test result upon entry into the study.
• • Agree to use a medically accepted form of birth control (oral, implant, injectable or transdermal contraceptives, intrauterine device, condom plus spermicide, diaphragm plus spermicide) or practice abstinence throughout the study period.
• • 7. Free from any systemic or dermatologic disorder that, in the opinion of the Investigator, will interfere with the study results or increase the risk of adverse events.
• • 8. Ability to apply study product to self or to other person if a child. If patient is a child, then parent/guardian will apply study product to him/her.
• Exclusion Criteria:
• • 1. Known hypersensitivity to permethrin cream or any of its components, ragweed or chrysanthemums, synthetic pyrethroids or pyrethrin.
• • 2. Use of any systemic or topical acaricide 1 month before enrollment.
• • 3. Patients with crusted/Norwegian scabies.
• • 4. Patients with an underlying immunodeficient state (including prolonged treatment with corticosteroids), immunosuppressive disorders requiring therapy, severe systemic disease and history of HIV infection.
• • 5. Any condition, medical, psychological, or social, that, in the Investigator's opinion, would interfere with participation in the study.
• • 6. Women who are pregnant, planning pregnancy or lactating.
• • 7. Family members of employees of the clinic or Investigator.
• • 8. Patients who, in the opinion of the Investigator, would be non-compliant with the requirements of the study protocol.
• • 9. Patients whose close personal contacts will not or are not willing to comply with standard of care for Scabies management.
• • 10. Patients less than 2 years of age.
• • 11. Patients or guardians of patients, who are unable or unwilling to give informed consent or assent respectively.
• • 12. Receipt of any drug as part of a research study within 30 days before screening.
• • 13. History of seizures.
• • 14. Severe cutaneous bacterial or fungal infections requiring therapy (including systemic and topical antibiotics) or coexisting dermatological disorder that could interfere with the diagnosis and subsequent monitoring of scabies.
• • 15. Treatment with systemic or topical corticosteroids less than 2 weeks and less than 1 week from enrollment, respectively.