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

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.

Inclusion Criteria:

• Signs of solar erythema of mild to moderate intensity resulting from voluntary exposure to sun within the last 72 hours
• Presence of lesions with some degree of symmetry to allow comparison between both pharmaceutical formulations
• Compliance of the subject to the treatment protocol
• Agreement with the terms of the informed consent by the participants or their legal guardians when younger than 18 years old

Exclusion Criteria:

• Pregnancy or risk of pregnancy
• Lactation
• Signs of solar erythema of severe intensity
• Use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study
• History of atopy or allergic diseases
• History of allergy to any component of the formulations
• Other conditions considered by the investigator as reasonable for non-eligibility