Clinical Trial: Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Gel) 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 Gel) of Dexchlorpheniramine Maleate in the Evaluation of Safety and Efficacy for the Relief of

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% gel) 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 ]

The evaluation of the pruritus will be made by a 10-point visual analog scale, answered by patients at each visit. The sum of weighted scores will be calculated for each sign / symptom in each patient.


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: November 8, 2010
Date Started:
Date Completion:
Last Updated: November 8, 2010
Last Verified: November 2010