Non-inferiority, Monocentric Comparative Open Study of Two Topical Pharmaceutical Preparations (Cream and Lotion) of Dexchlorpheniramine Maleate in the Evaluation of Safety and Efficacy for the Relief of Insect Bite Related-symptoms

NCT00995397 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% lotion) 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	30

Conditions

• Insect Bites

Interventions

• Dexchlorpheniramine 1% lotion
• Dexchlorpheniramine 1% cream

Primary outcomes

• Pruritus intensity at insect bite site, evaluated with a 10 point Visual Analogic Scale (VAS) — 7 days

Countries

Brazil