NCT00928447

Study of the Intradermal Injection of rHuPH20 or Placebo in Participants With Nickel Allergic Contact Dermatitis

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of the Intradermal Injection of rHuPH20 or Placebo in Subjects With Nickel Allergic Contact Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Halozyme Therapeutics · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will involve 2 regimens which will run in parallel. Each participant's upper back will be divided into 2 equal spaces for Regimen 1 and 2. Each of the 4 treatment sites in each space will be independently randomized to placebo or rHuPH20 treatment in a 1:1 ratio. Thus, each participant will serve as their own control. Regimen 1 will evaluate the treatment of cutaneous reactions to nickel and Regimen 2 will evaluate the prevention as well as the treatment of cutaneous reactions to nickel. At screening, the nickel sulfate concentration (1%, 2.5%, or 5%) applied to the skin of the upper back with a patch, that will cause no more than a ++ reaction according to the scale of the International Contact Dermatitis Research Group (ICDRG) will be determined. This concentration will be used to elicit cutaneous reactions during the study period.

Conditions

• Dermatitis, Allergic Contact

Interventions

Type	Name	Description
DRUG	rHuPH20	0.25 milliliter (mL) Intradermal (ID) syringe push bolus injection of rHuPH20
DRUG	Placebo	0.25 mL ID syringe push bolus injection of placebo control

Timeline

• Start date: 2009-06-23
• Primary completion: 2009-09-13
• Completion: 2009-09-13
• First posted: 2009-06-26
• Last updated: 2021-12-17
• Results posted: 2021-12-17

Locations

1 site across 1 country: United States