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

Study Status: Completed
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: 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% lotion) with the standard preparation (1% cream) for the relief of sunburn related symptoms and to demonstrate the safety of both preparations.

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

Current Primary Outcome: Pruritus intensity 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 burning sensation performed by the investigator using a 4-point scale for each one of the variables (absent, mild, moderate, intense). [ Time Frame: 7 days ]

Original Secondary Outcome: Same as current

Information By: Mantecorp Industria Quimica e Farmaceutica Ltd.

Dates:
Date Received: March 11, 2010
Date Started:
Date Completion:
Last Updated: March 11, 2010
Last Verified: October 2009