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

October 20, 2009 updated by: Mantecorp Industria Quimica e Farmaceutica Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sérgio Schalka, MD
  • Phone Number: +551136811334

Study Locations

  • Brazil
    • São Paulo
      • Osasco, São Paulo, Brazil, 06023-000
        • Medcin Instituto da Pele Ltda.
        • Contact:
          • Patrícia C Pinto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 58 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexchlorpheniramine 1% lotion
Drug: Dexchlorpheniramine 1% lotion
Small amount applied over the lesion twice a day for 7 days.
Active Comparator: Dexchlorpheniramine 1% cream
Drug: Dexchlorpheniramine 1% cream
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)
Time Frame: 7 days
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.
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mantecorp Industria Quimica e Farmaceutica Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 14, 2009

First Submitted That Met QC Criteria

October 14, 2009

First Posted (Estimate)

October 15, 2009

Study Record Updates

Last Update Posted (Estimate)

October 22, 2009

Last Update Submitted That Met QC Criteria

October 20, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERP 976-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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