Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.
Condition: Scabies
MeSH terms: Scabies
Intervention: Permethrin Cream, 5%; Elimite
Intervention description: Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.; Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
Intervention MeSH terms: Permethrin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a multi-center, double-blind, randomized, two arm parallel design study. This study
      is comprised of two phases: screening and treatment. The screening period will be up to 5
      days, followed by the treatment phase of 28±4 days. During the treatment phase subjects will
      be randomized to receive either test or reference treatments in a double-blind manner in an
      outpatient setting. Randomization of subjects will be in a 1:1 ratio for the test and
      reference drug arms and will be stratified by site.

      Screening will begin at visit 1, during which eligibility will be determined and prohibited
      treatments will be discontinued. Randomization will occur following the confirmation of the
      eligibility criteria at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The
      treatment phase will be 28±4 days in duration wherein subject will receive treatment with
      investigational product (either test or reference) on Day 1 or Baseline (visit 2). Safety and
      tolerability assessments will be performed on Day 7 (visit 3). Efficacy, safety and
      tolerability will be assessed on Day 14 (visit 4) followed by the End of study visit on Day
      28 (visit 5). If positive identification of scabies is confirmed at Day 14 (visit 4), the
      subject will be retreated with the second application of the investigational product.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or non-pregnant, non-lactating female subject at least 12 years of age or older.

          2. Subject must have a positive identification for mites, eggs, or mite fecal matter by
             microscopic examination of a skin scraping.

          3. Subjects must have at least two of the three following: a) excoriations and
             inflammatory papules with a typical distribution pattern and localization (webbed
             spaces of the fingers, flexor surfaces of the wrists, elbows, axillae, belt line,
             feet, skin surface of external genitalia, or areolae); b) presence of burrows; c)
             family or contacts with moderate to severe itching which increases during the night.

          4. Subjects must be willing to make every effort to immediately disinfect clothes,
             towels, and linens and all potentially infected household items upon diagnosis of
             infestation to prevent re-infestation.

          5. All household members with prolonged physical contact with the subject must be willing
             to attend Baseline visit and receive treatment with standard of care if deemed
             necessary by the Investigator in order to prevent re-infestation of the subject
             enrolled.

          6. Subject or representative must read and sign an Institutional Review Board/Independent
             Ethics Committee (IRB/IEC) approved Informed Consent Form (ICF); for minor subjects
             (18 years or younger in most states) the parent or legal guardian should sign the ICF
             and the child will be required to sign the Assent Form that will written in such a way
             as to be understandable to a child.

          7. Subject must be able to apply study product to self. If the subject is a child, then
             parent/guardian will apply study product to him/her.

        Exclusion Criteria:

          1. Females who are pregnant as shown in a urine pregnancy test at the Baseline visit,
             prior to randomization, or lactating, or of childbearing potential (for purpose of
             this study a female of childbearing potential is considered to be not surgically
             sterile or postmenopausal for at least 1 year) who are not using or do not agree to
             use an acceptable form of contraception (oral /implant /injectable /transdermal
             contraceptives, intrauterine device (IUD), condom, diaphragm, or abstinence) during
             the study, or who intends to become pregnant during the study; contraceptive method
             must also be consistent throughout the study.

          2. Treatment for scabies <4 weeks prior to enrollment, including permethrin, benzyl
             alcohol, lindane, crotamiton, malathion, and ivermectin.

          3. Use of prohibited medications:

               -  Topical or oral scabicidal/antiparasitic treatment including: permethrin, 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 visit 2.

               -  Systemic corticosteroids (including inhaled steroids) taken within 14 days of
                  visit 2.

               -  Topical corticosteroids including hydrocortisone taken within 24 hours of visit
                  2.

               -  Topical antipruritics, including antihistamines within 24 hours of any study
                  visits.

               -  Oral antihistamine including diphenhydramine (Benadryl) taken within 24 hours of
                  any study visits.

               -  Topical antibiotics including mupirocin taken within 24 hours of any study
                  visits.

          4. Patients with immunosuppressive disorders requiring therapy, severe systemic disease,
             history of HIV infection and/or seizures.

          5. Patients with crusted/Norwegian scabies.

          6. Presence of underlying skin disease that would obscure evaluation of the papules and
             burrows associated with scabies infection as determined by the Investigator.

          7. Presence of severe cutaneous bacterial or fungal infections requiring therapy
             (including systemic and topical antibiotics) as determined by the Investigator.

          8. Sensitivity or allergy to Permethrin Cream or any of its components, synthetic
             pyrethroids, pyrethrin, chrysanthemums or ragweed.

          9. A recent (less than 1 year) history of alcoholism, drug abuse, or other problems which
             would likely make the subject unreliable for the study.

         10. Participation in another investigational study or using any investigational product
             within the 30 days prior to the Baseline visit.

         11. Participation of family member, or another member of the household (including regular
             bedmates) in the current study.

         12. Total number of bedmates and family members with prolonged physical contact is greater
             than 6 (including study subject).

         13. Any employees of the clinic, investigators, or family members of the study staff.

         14. Patients who in the opinion of the Investigator would be non-compliant with the
             requirements of the study protocol.