Comparative Study of Two Forms of Topical Dexchlorpheniramine Maleate (Cream Versus Gel) for Insect Bites
Status:
Unknown status
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
Insect bite related symptoms (pruritus and papules) are caused by the release of histamine by
mast cells in the skin. Topical anti-histaminics can be used to promote relief of these
symptoms. Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation
approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the
ones caused by insect bites. The aim of the present study is to demonstrate non-inferiority
of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the
standard preparation (1% cream) for the relief of insect bite related symptoms and to
demonstrate the safety of both preparations.