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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

October 14, 2009
October 20, 2009
Not Provided
Not Provided
Pruritus intensity at insect bite site, evaluated with a 10 point Visual Analogic Scale (VAS) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00995397 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Insect Bite Related Symptoms
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Insect Bites
  • Drug: Dexchlorpheniramine 1% lotion
    Small amount applied over the lesion twice a day for 7 days.
  • Drug: Dexchlorpheniramine 1% cream
    Small amount applied over the lesion twice a day for 7 days.
  • Experimental: Dexchlorpheniramine 1% lotion
    Intervention: Drug: Dexchlorpheniramine 1% lotion
  • Active Comparator: Dexchlorpheniramine 1% cream
    Intervention: Drug: Dexchlorpheniramine 1% cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
Not Provided
Not Provided

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
Both
2 Years to 60 Years
No
Contact: Sérgio Schalka, MD +551136811334
Brazil
 
NCT00995397
ERP 976-08
Yes
Celso Pereira Sustovich, Medical Director, Mantecorp Industria Quimica e Farmaceutica Ltda.
Mantecorp Industria Quimica e Farmaceutica Ltd.
Not Provided
Not Provided
Mantecorp Industria Quimica e Farmaceutica Ltd.
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP