NCT01237925

Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Gel) in the Relief of Sunburn Related Symptoms

Non-inferiority, Monocentric Comparative Open Study of Two Topical Pharmaceutical Preparations (Cream and Gel) of Dexchlorpheniramine Maleate in the Evaluation of Safety and Efficacy for the Relief of Mild to Moderate Sunburn Related Symptoms

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd. · Industry
• Sex: All
• Age: 2 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus, including the ones caused by sunburn. 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 sunburn related symptoms and to demonstrate the safety of both preparations.

Conditions

• Sunburn

Interventions

Type	Name	Description
DRUG	Dexchlorpheniramine 1% gel	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: 2010-11-10
• Last updated: 2010-11-10

Locations

1 site across 1 country: Brazil