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

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ClinicalTrials.gov Identifier: NCT00995397
Recruitment Status : Unknown
Verified October 2009 by Mantecorp Industria Quimica e Farmaceutica Ltd..
Recruitment status was:  Not yet recruiting
First Posted : October 15, 2009
Last Update Posted : October 22, 2009
Information provided by:

Study Description
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% lotion) 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% lotion Drug: Dexchlorpheniramine 1% cream Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 the National Library of Medicine

MedlinePlus related topics: Itching
U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

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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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00995397

Contact: Sérgio Schalka, MD +551136811334

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

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
First Posted: October 15, 2009    Key Record Dates
Last Update Posted: October 22, 2009
Last Verified: October 2009

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