Back to resultsComparative Study of Two Forms of Topical Dexchlorpheniramine Maleate (Cream Versus Gel) for Insect Bites
Primary Purpose
Insect Bites
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Dexchlorpheniramine 1% Gel
Dexchlorpheniramine 1% Cream
Sponsored by
About this trial
This is an interventional treatment trial for Insect Bites focused on measuring Insect bites, Dexchlorpheniramine, Gel, Cream
Eligibility 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.
Sites / Locations
- Medcin Instituto da Pele Ltda.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Dexchlorpheniramine 1% Cream
Dexchlorpheniramine 1% Gel
Arm Description
Outcomes
Primary Outcome Measures
Pruritus Intensity at Insect Bite Site, Evaluated With a 10 Point Visual Analogic Scale (VAS)
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.
Full Information
NCT ID
NCT01233934
First Posted
November 2, 2010
Last Updated
November 2, 2010
Sponsor
Mantecorp Industria Quimica e Farmaceutica Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01233934
Brief Title
Comparative Study of Two Forms of Topical Dexchlorpheniramine Maleate (Cream Versus Gel) for Insect Bites
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
July 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Mantecorp Industria Quimica e Farmaceutica Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. 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% gel) with the standard preparation (1% cream) for the relief of insect bite related symptoms and to demonstrate the safety of both preparations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insect Bites
Keywords
Insect bites, Dexchlorpheniramine, Gel, Cream
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexchlorpheniramine 1% Cream
Arm Type
Active Comparator
Arm Title
Dexchlorpheniramine 1% Gel
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dexchlorpheniramine 1% Gel
Intervention Description
Small amount applied over the lesion twice a day for 7 days.
Intervention Type
Drug
Intervention Name(s)
Dexchlorpheniramine 1% Cream
Intervention Description
Small amount applied over the lesion twice a day for 7 days.
Primary Outcome Measure Information:
Title
Pruritus Intensity at Insect Bite Site, Evaluated With a 10 Point Visual Analogic Scale (VAS)
Time Frame
7 days
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergio Schalka, MD
Phone
551136811334
Email
medci004@terra.com.br
Facility Information:
Facility Name
Medcin Instituto da Pele Ltda.
City
Osasco
State/Province
São Paulo
ZIP/Postal Code
06023000
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Schalka, MD
12. IPD Sharing Statement
Learn more about this trial
Comparative Study of Two Forms of Topical Dexchlorpheniramine Maleate (Cream Versus Gel) for Insect Bites
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