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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Mantecorp Industria Quimica e Farmaceutica Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Mantecorp Industria Quimica e Farmaceutica Ltd.
ClinicalTrials.gov Identifier:
NCT01233934
First received: November 2, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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 Intervention Phase
Insect Bites
Drug: Dexchlorpheniramine 1% Gel
Drug: Dexchlorpheniramine 1% Cream
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:

Primary Outcome Measures:
  • Pruritus Intensity at Insect Bite Site, Evaluated With a 10 Point Visual Analogic Scale (VAS) [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: February 2011
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   2 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233934

Contacts
Contact: Sergio Schalka, MD 551136811334 medci004@terra.com.br

Locations
Brazil
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.
  More Information

No publications provided

Responsible Party: Celso Sustovich, Medical Director
ClinicalTrials.gov Identifier: NCT01233934     History of Changes
Other Study ID Numbers: ERP 185v3-10
Study First Received: November 2, 2010
Last Updated: November 2, 2010
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Dexchlorpheniramine
Chlorpheniramine
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipruritics
Dermatologic Agents
Therapeutic Uses
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 16, 2014