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

Mantecorp Industria Quimica e Farmaceutica Ltd.124 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

124

Conditions

Sunburn

Interventions

Dexchlorpheniramine 1% gel

Eligibility

Sex: ALLMin age: 2 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signs of solar erythema of mild to moderate intensity resulting from voluntary exposure to sun within the last 72 hours * 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 severe sunburn (vesicles, bullae or ulceration) * 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

Outcomes

Primary Outcomes

Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS)

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.

Time frame: 7 days

Secondary Outcomes

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).