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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01233934
Recruitment Status : Unknown
Verified November 2010 by Mantecorp Industria Quimica e Farmaceutica Ltd..
Recruitment status was:  Not yet recruiting
First Posted : November 3, 2010
Last Update Posted : November 3, 2010
Information provided by:
Mantecorp Industria Quimica e Farmaceutica Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Insect Bites Drug: Dexchlorpheniramine 1% Gel Drug: Dexchlorpheniramine 1% Cream Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2011
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Pruritus Intensity at Insect Bite Site, Evaluated With a 10 Point Visual Analogic Scale (VAS) [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   2 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01233934

Contact: Sergio Schalka, MD 551136811334

Medcin Instituto da Pele Ltda. Not yet recruiting
Osasco, São Paulo, Brazil, 06023000
Principal Investigator: Sergio Schalka, MD         
Sponsors and Collaborators
Mantecorp Industria Quimica e Farmaceutica Ltd.

Responsible Party: Celso Sustovich, Medical Director Identifier: NCT01233934     History of Changes
Other Study ID Numbers: ERP 185v3-10
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: November 3, 2010
Last Verified: November 2010

Keywords provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:
Insect bites

Additional relevant MeSH terms:
Insect Bites and Stings
Bites and Stings
Chemically-Induced Disorders
Wounds and Injuries
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dermatologic Agents
Anti-Allergic Agents