Cumulative Irritation Potential of 828 Ointment
Condition: Healthy Volunteers
Intervention: HP828-101
Intervention description: 21 day patches
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cumulative irritation; healthy adult volunteers

Summary:

      Cumulative Irritation Patch Test
    

Eligibility criteria:

        1. SUBJECTS 1.1 SUBJECT POPULATION

        Subjects will be normal, healthy volunteers of either gender aged 18 to 65 years.

        Inclusion Criteria:

        Subjects must satisfy all of the following criteria:

          1. Subjects must be ambulatory, 18 to 65 years of age and in reasonably good health.

          2. Subjects may be of any ethnicity or skin type provided their skin pigmentation does
             not interfere with evaluations.

          3. Female subjects must be surgically sterile, post-menopausal or using an acceptable
             method of birth control and all females of childbirth potential must be willing to
             take a urine pregnancy test at the beginning and at the end of the study.

          4. Minor deviations in normal medical history not considered to be clinically significant
             by the investigator and the sponsor will be permitted.

          5. Subjects must refrain from sunbathing, using tanning salons, swimming or using hot
             tubs during the course of the study.

          6. Bathing is permitted, however, subjects must agree to attempt to keep the patches as
             dry as possible.

          7. Subjects must read and sign an IRB approved informed consent form.

        Exclusion Criteria:

        Subjects with any of the following conditions are not eligible for participation:

          1. Any systemic disease or disorder, complicating factors or structural abnormality that
             would negatively affect the conduct or outcome of the study (i.e., hepatitis, acute or
             chronic renal insufficiency).

          2. Use of a prescribed pain medication, prescribed or over-the-counter anti-inflammatory
             drugs, immunosuppressive drugs or prescribed antihistamine medication (steroid nose
             drops and/or eye drops are permitted). Use of any over-the-counter pain medication
             that is ingested in quantities exceeding label instructions.

          3. Subjects who have received an investigational drug or have participated in a patch
             test within the past 28 days or who are currently participating in or plan to enter a
             clinical trial.

          4. A history of non-compliance or subjects who are considered potentially unreliable.

          5. A history of skin allergies, including known sensitivity or strong reactions to any
             cosmetics and/or personal care products, topically prepared medical dressings, tapes
             or adhesives.

          6. A history of clinically significant skin diseases which may contraindicate
             participation, including psoriasis, active eczema, atopic dermatitis and active
             cancer, even if currently controlled through medication.

          7. Current use of topical or oral antibiotics.

          8. Use of topical medications at the test area 2 weeks prior to enrollment or any body
             lotions/oils/creams at the test area for 48 hours prior to enrollment and throughout
             the trial.

          9. Female subjects who are pregnant, stop contraceptive measures, expect to become
             pregnant or who are breast-feeding.

         10. Subjects with any condition known to interfere with the absorption, distribution,
             metabolism or excretion of drugs.

         11. Subjects with hematological disorders or immunologic disorders (HIV positive, AIDS and
             Systemic Lupus Erythematosus).

         12. Subjects with any significant organ abnormality or disorders including gastric
             ulcer/insulin dependent diabetes.

         13. Subjects with any clinically significant illness (sought medical attention, fever,
             took prescription medication) within the 4 weeks prior to study entry.

         14. History of asthma, chronic bronchitis or any other bronchospastic condition that
             requires medication.

         15. Known history of either real or suspected allergy or sensitization to any test article
             ingredient.

         16. Anticipated change in the use of a systemic medication during the study that may
             affect the conduct or outcome of the study. Subjects must be stabilized on these
             medications for at least one month prior to receiving study drug and continue the same
             regimen throughout the study.

         17. Bilateral mastectomy involving removal of lymph nodes.

         18. Treatment of any type of cancer within the last six months.

         19. The Principal Investigator may declare any subject ineligible for a sound medical
             reason.