NCT00995397

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd. · Industry
• Sex: All
• Age: 2 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insect Bites

Interventions

Type	Name	Description
DRUG	Dexchlorpheniramine 1% lotion	Small amount applied over the lesion twice a day for 7 days.
DRUG	Dexchlorpheniramine 1% cream	Small amount applied over the lesion twice a day for 7 days.

Timeline

• First posted: 2009-10-15
• Last updated: 2009-10-22

Locations

1 site across 1 country: Brazil