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

Study Overview
=================
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.

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 of Sunburn Related Symptoms

Conditions
-----------------
Sunburn

Intervention / Treatment
-----------------
* Drug: Dexchlorpheniramine 1% lotion
* Drug: Dexchlorpheniramine 1% cream


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexchlorpheniramine 1% lotion<br> | Drug: Dexchlorpheniramine 1% lotion<br>* Small amount applied over the lesion twice a day for 7 days<br>|
| Active Comparator: Dexchlorpheniramine 1% cream<br> | Drug: Dexchlorpheniramine 1% cream<br>* Small amount applied over the lesion twice a day for 7 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS) |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sunburn, Dexchlorpheniramine, Lotion, Cream