Who is sponsoring NCT01233934?

NCT01233934 is sponsored by Mantecorp Industria Quimica e Farmaceutica Ltd..

What condition does NCT01233934 study?

NCT01233934 studies Insect Bites.

What drugs are being tested in NCT01233934?

Interventions: Dexchlorpheniramine 1% Gel, Dexchlorpheniramine 1% Cream.

What is the status of NCT01233934?

NCT01233934 is currently UNKNOWN.

Last reviewed 2010-11-02 · How we verify

Comparative Study of Two Forms of Topical Dexchlorpheniramine Maleate (Cream Versus Gel) for Insect Bites

NCT01233934 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Mantecorp Industria Quimica e Farmaceutica Ltd.
Phase	Phase 3
Status	UNKNOWN
Enrolment	90
Start date	2011-02
Completion	2011-07

Conditions

Insect Bites

Interventions

Dexchlorpheniramine 1% Gel
Dexchlorpheniramine 1% Cream

Primary outcomes

Pruritus Intensity at Insect Bite Site, Evaluated With a 10 Point Visual Analogic Scale (VAS) — 7 days

Countries

Brazil