Comparative Study of Two Forms of Topical Dexchlorpheniramine Maleate (Cream Versus Gel) for Insect Bites

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% gel) with the standard preparation (1% cream) for the relief of insect bite related symptoms and to demonstrate the safety of both preparations.

Study Overview

• Status: Unknown
• Conditions: Insect Bites
• Intervention / Treatment: Drug: Dexchlorpheniramine 1% Cream; Drug: Dexchlorpheniramine 1% Gel

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sergio Schalka, MD; Phone Number: 551136811334; Email: medci004@terra.com.br

Study Locations

• Brazil
  • São Paulo
    • Osasco, São Paulo, Brazil, 06023000
      • Medcin Instituto da Pele Ltda.
      • Principal Investigator: Sergio Schalka, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexchlorpheniramine 1% Cream	Drug: Dexchlorpheniramine 1% Cream; Small amount applied over the lesion twice a day for 7 days.
Experimental: Dexchlorpheniramine 1% Gel	Drug: Dexchlorpheniramine 1% Gel; Small amount applied over the lesion twice a day for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pruritus Intensity at Insect Bite Site, Evaluated With a 10 Point Visual Analogic Scale (VAS)	7 days

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): July 1, 2011

Study Registration Dates

• First Submitted: November 2, 2010
• First Submitted That Met QC Criteria: November 2, 2010
• First Posted (Estimate): November 3, 2010

Study Record Updates

• Last Update Posted (Estimate): November 3, 2010
• Last Update Submitted That Met QC Criteria: November 2, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Gel; Insect bites; Dexchlorpheniramine; Cream
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Wounds and Injuries; Poisoning; Bites and Stings; Insect Bites and Stings; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Chlorpheniramine; Dexchlorpheniramine
• Other Study ID Numbers: ERP 185v3-10