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

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.