Study of the Intradermal Injection of rHuPH20 or Placebo in Participants With Nickel Allergic Contact Dermatitis
Condition: Dermatitis, Allergic Contact
MeSH terms: Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact
Intervention: rHuPH20; Placebo
Intervention description: 0.25 milliliter (mL) Intradermal (ID) syringe push bolus injection of rHuPH20; 0.25 mL ID syringe push bolus injection of placebo control
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: rHuPH20; Recombinant Human hyaluronidase

Summary:

      The purpose of this study is to compare the effect and safety of rHuPH20 or placebo for the
      prevention and treatment of skin allergic reaction to nickel. The study drug and placebo will
      be administered by intradermal injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females 18-60 years of age. Females of child-bearing potential must use a standard and
             effective means of birth control for the duration of the study.

          -  Known contact dermatitis to nickel with a confirmed positive patch-test result to
             nickel sulfate.

          -  Intact normal skin without potentially obscuring tattoos, acne, dermatitis,
             pigmentation or lesions on the posterior aspect of the torso (back) in the area
             intended for allergen testing and dose administration.

          -  Vital signs (blood pressure [BP], heart rate [HR], temperature, respiratory rate)
             within normal range or, if out of range, assessed by the Investigator as not
             clinically significant and it is mutually agreed by both Investigator and sponsor
             medical monitor that the participant need not be excluded from the study for this
             reason.

          -  A negative serum or urine pregnancy test (if female of child-bearing potential) within
             14 days of initial study drug administration.

          -  Participant should be in good general health based on medical history and physical
             examination, without medical conditions that might prevent the completion of study
             drug injections and assessments required in this protocol.

          -  Decision-making capacity and willingness and ability to comply with the requirements
             for full completion of the study.

          -  Signed, written Institutional Review Board (IRB)/Ethics Committee (EC)-approved
             informed consent.

        Exclusion Criteria:

          -  Nickel allergen patch test greater than a ++ reaction.

          -  Participants who were treated with chemotherapy agents or systemic corticosteroids
             within the past 3 months.

          -  Use of topical steroids, antihistamines, or immunosuppressants used near the site of
             allergen testing/injection within 14 days.

          -  Use of oral antihistamines within 14 days of study conduct.

          -  Extensive ongoing outbreaks of contact dermatitis anywhere on the body.

          -  Pregnant or women who are breast-feeding.

          -  Participants with a current disease state that can affect immune response (for
             example, flu, cancer, human immunodeficiency virus [HIV]).

          -  Known allergy to any hyaluronidase or the ingredients in the dose preparation.

          -  History of autoimmune disorder.

          -  Participants with any other medical condition that, in the opinion of the
             investigator, might significantly affect their ability to safely participate in the
             study or affect the conduct of this study. Examples might include asthma, diabetes,
             heart disease, epilepsy, cancer, etc.