Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% in the Treatment of Scabies
Condition: Scabies
MeSH terms: Scabies
Intervention: Permethrin Cream, 5%; Elimite™ Cream (permethrin) 5%
Intervention description: Permethrin Cream 5%; Permethrin Cream 5%
Intervention MeSH terms: Permethrin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be assigned to the test or reference permethrin to treat scabies.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The study product will be randomized, packaged and blinded so that the packaging for both treatments look identical.
Enrollment: 254.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      Study to Evaluate the Therapeutic Equivalence of Permethrin Cream 5%in the Treatment of
      Scabies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or non-pregnant, non-lactating female, 2 years of age or older.

          2. If female and of childbearing potential, prepared to abstain from sexual intercourse
             or use a reliable method of contraception during the study (e.g., double barrier
             methods, intrauterine device (IUD), oral, transdermal or injected hormonal
             contraceptives). Female patients using hormonal contraceptives should have been on the
             same product/dosing regimen for at least 28 days before baseline and should not change
             this regimen during the study.

          3. Signed informed consent that meets all criteria of current FDA and International
             Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
             (ICH) regulations. For patients who are considered minors in the state the study is
             being conducted (< 18 years in most states) the parent or legal guardian should sign
             the consent form and the child will be required to sign a patient "assent" form, as
             appropriate. Patients 11-17 years of age will read and sign an Independent Review
             Board (IRB)-approved assent form and patients 6-10 years of age will provide verbal
             assent. Patients 2-5 years of age will be exempt from providing assent based on the
             child's comprehension and cognitive skills.

          4. Clinical diagnosis of active scabies by presence of a burrow and/or typical scabietic
             lesions at the classic sites of infestation.

          5. Parasitological confirmation of clinical diagnosis with demonstration under light
             microscope of mites and/or their products (larvae, eggs or fecal material).

          6. Symptom score of 2 or 3 on a 4-point rating scale of 0-3 for nocturnal
             itching/pruritus.

          7. Ability to apply or have study product applied as directed. If patient is a child,
             then parent/guardian will apply study product to him/her.

        Exclusion Criteria:

          1. Patients who are pregnant, lactating, or planning to become pregnant during the study.

          2. 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 (AEs).

          3. Known hypersensitivity to permethrin cream or any of its components.

          4. Use of any systemic or topical acaricide or ectoparasiticide within one month before
             Screening.

          5. Patient has signs of a systemic infection or is receiving systemic therapy for an
             infectious disease.

          6. Patients with 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) or
             heavily crusted with lesions consistent with Norwegian scabies.

          7. Patients with an underlying immunodeficient state (including prolonged treatment with
             corticosteroids), immunosuppressive disorders requiring therapy, severe systemic
             disease and history of HIV infection.

          8. Any condition, medical, psychological, or social, that, in the Investigator's opinion,
             would interfere with participation in the study.

          9. Family members of employees of the clinic or Investigator.

         10. Patients who, in the opinion of the Investigator, would be non-compliant with the
             requirements of the study protocol.

         11. Patients whose close personal contacts will not or are not willing to comply with
             standard of care for Scabies management.

         12. Receipt of any drug as part of a research study within 30 days before Screening.

         13. History of seizures.

         14. Use of systemic corticosteroids within two weeks before Screening.

         15. Use of topical corticosteroids within one week before Screening.

         16. Previous participation in this study.