Clinical Trial: Study of the Intradermal Injection of rHuPH20 or Placebo in Subjects With Nickel Allergic Contact Dermatitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of the Intradermal Injection of rHuPH20 or Placebo in Subjects With Nickel Allergic Contact Derma
Brief Summary: The purpose of this study is to compare the effect and safety of rHuPH20 or placebo for the treatment of skin allergic reaction to nickel. The study drug and placebo will be administered by intradermal injection.
Detailed Summary: This is a pilot Phase II, prospective, double-blind, placebo-controlled study to compare the efficacy, safety and tolerability of rHuPH20 or placebo control administered intradermally (ID) in the prevention and treatment of subjects with contact allergy to nickel. This study will involve two treatment regimens, which will run in parallel (Treatment Regimens 1 and 2).
Sponsor: Halozyme Therapeutics
Current Primary Outcome: Determine the treatment effect of rHuPH20 or placebo control injection on the exposure to topical nickel allergen [ Time Frame: 7-14 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Determine the time to onset and severity of the cutaneous reaction to nickel allergen after pre-treatment with rHuPH20 or placebo control [ Time Frame: 7-14 days ]
- Assess the safety and tolerability of the rHuPH20 injection [ Time Frame: 7-14 days ]
Original Secondary Outcome: Same as current
Information By: Halozyme Therapeutics
Dates:
Date Received: June 25, 2009
Date Started: June 2009
Date Completion:
Last Updated: September 10, 2012
Last Verified: September 2012
