Conditions: Allergic Skin Reaction
Keywords: hyaluronidase enzymes with tissue spreading activity allergic reaction intradermal skin testing
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 253
Healthy volunteers: yes

Brief summary:
This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers using an intradermal skin test.

Detailed description:

Arms:
arm 1: Intradermal injection of Amphadase (hyaluronidase 150 USP units/mL) arm 2: Intradermal injection of Histatrol (histamine base 0.1 mg/mL) arm 3: Intradermal injection of saline (0.02 mL)

Interventions: intervention 1: Hyaluronidase intervention 2: Histamine intervention 3: Saline
Intervention descriptions: intervention 1: Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two random sites on their forearms. intervention 2: Subjects received one intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one random sites on their forearms. intervention 3: Subjects received one intradermal injection of 0.02 mL saline at one random site on their forearm.

Protocol document: