Dermal Safety Study to Evaluate Potential Irritation of Abametapir Lotion
Condition: Head Lice
Intervention: Abametapir Lotion 0.74% w/w; Sodium Lauryl Sulfate; Saline 0.9%; Placebo
Intervention description: applied 0.2 mL topically under occlusive condition; Sodium Lauryl Sulfate is prepared as a 0.2% aqueous solution by the site for topical administration, and applied 21 times over consecutive days under occlusive conditions, will serve as a positive control.; A solution of 0.9% saline for topical administration, applied 21 times over consecutive days under occlusive conditions, will serve as a negative control
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hatchtech

Summary:

      The purpose of the study is to determine the irritation potential of repeat applications of
      abametapir lotion on normal skin.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Are healthy (to be confirmed by medical history) males or females, 18 years of age or
             older;

          2. In the case of females of childbearing potential, are using an acceptable form of
             birth control (oral/implant/injectable/transdermal contraceptives, intrauterine
             device, condom with spermicide, diaphragm with spermicide, abstinence, partner's
             vasectomy). Abstinence or vasectomized partner are acceptable if the female subject
             agrees to implement one of the other acceptable methods of birth control if her
             lifestyle/partner changes;

          3. If female of childbearing potential, have a negative urine pregnancy test (UPT) at Day
             1, and are willing to submit to a pregnancy test at the end of study (EOS);

          4. Are free of any systemic or dermatologic disorder, which, in the opinion of the
             investigator, will interfere with the study results or increase the risk of adverse
             events;

          5. Are of any skin type or race, providing the skin pigmentation will allow discernment
             of erythema;

          6. Complete a patch study Medical Screening form as well as a Medical Personal History
             form; and

          7. Read, understand, and provide signed informed consent.

        Exclusion Criteria:

          1. Have any visible skin disease at the application site which, in the opinion of the
             investigative personnel, will interfere with the evaluation of the test site reaction;

          2. Are not willing to refrain from using topical/systemic analgesics such as aspirin
             (daily use of 81 mg aspirin is acceptable), Aleve, Motrin, Advil, or Nuprin for 72
             hours prior to and during the study (occasional use of acetaminophen will be
             permitted);

          3. Are using inhaled/systemic/topical corticosteroids in the 3 weeks prior to and during
             the study, or systemic/topical antihistamines for 72 hours prior to and during the
             study;

          4. Are using medication which, in the opinion of the investigative personnel, will
             interfere with the study results, including anti-inflammatory medications;

          5. Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams,
             ointments, lotions, or similar products on the back during the study;

          6. Have psoriasis and/or active atopic dermatitis/eczema;

          7. Are females who are pregnant, plan to become pregnant during the study, or are
             breast-feeding a child;

          8. Have a known sensitivity to constituents present in the material being evaluated;

          9. Have damaged skin in or around the test sites, including sunburn, excessively deep
             tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other
             disfigurations of the test site

         10. Have received treatment for any type of internal cancer within 5 years prior to study
             entry;

         11. Have a history of, or are currently being treated for skin cancer;

         12. Are currently participating in any other clinical trial,

         13. Have any known sensitivity to adhesives; and/or

         14. Have received any investigational treatment(s) within 4 weeks prior to study entry.