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

Study Overview
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Brief Summary
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Insect bite related symptoms (pruritus and papules) are caused by the release of histamine by mast cells in the skin. Topical anti-histaminics can be used to promote relief of these symptoms. Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the ones caused by insect bites. 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 insect bite related symptoms and to demonstrate the safety of both preparations.

Official Title
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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 Insect Bite Related-symptoms

Conditions
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Insect Bites

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of papules resulting from insect bites within the last 72 hours Presence of symmetric lesions to compare one side to the other 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 Use of topical or systemic anti-inflammatory, anti-histaminics or immunosuppressive drugs within the last 48 hours prior to the study History of atopy or allergic diseases History of allergy of any component of the formulations Other conditions considered by the investigator as reasonable for non-eligibility

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pruritus intensity at insect bite site, 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 papule formation, performed by the investigator using a 4-point scale for each one of the parameters (absent, mild, moderate, intense). This evaluation constitutes the Insect Bite Score. |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insect bites, Dexchlorpheniramine, Lotion, Cream