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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 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:
NCT00995397
First received: October 14, 2009
Last updated: October 20, 2009
Last verified: October 2009
History of Changes
  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% lotion) 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% lotion
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
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Itching
U.S. FDA Resources

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: 30
Arms Assigned Interventions
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.

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995397

Contacts
Contact: Sérgio Schalka, MD +551136811334

Locations
Brazil
Medcin Instituto da Pele Ltda. Not yet recruiting
Osasco, São Paulo, Brazil, 06023-000
Contact: Patricia C Pinto            
Sponsors and Collaborators
Mantecorp Industria Quimica e Farmaceutica Ltd.
  More Information

No publications provided

Responsible Party: Celso Pereira Sustovich, Medical Director, Mantecorp Industria Quimica e Farmaceutica Ltda.
ClinicalTrials.gov Identifier: NCT00995397     History of Changes
Other Study ID Numbers: ERP 976-08
Study First Received: October 14, 2009
Last Updated: October 20, 2009
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Insect Bites and Stings
Bites and Stings
Poisoning
Substance-Related Disorders
Dexchlorpheniramine
Chlorpheniramine
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on May 23, 2013