Clinical Trial: Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Insect Bite Related Symptoms

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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

Brief 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% lotion) with the standard preparation (1% cream) for the relief of insect bite related symptoms and to demonstrate the safety of both preparations.

Detailed Summary:
Sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.

Current Primary Outcome: Pruritus intensity at insect bite site, evaluated with a 10 point Visual Analogic Scale (VAS) [ Time Frame: 7 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Composite clinical evaluation of erythema, pruritus and papule formation, performed by the investigator using a 4-point scale for each one of the parameters (absent, mild, moderate, intense). This evaluation constitutes the Insect Bite Score. [ Time Frame: 7 days ]

Original Secondary Outcome: Same as current

Information By: Mantecorp Industria Quimica e Farmaceutica Ltd.

Dates:
Date Received: October 14, 2009
Date Started:
Date Completion:
Last Updated: October 20, 2009
Last Verified: October 2009