Status:
UNKNOWN
Comparative Study of Two Forms of Topical Dexchlorpheniramine Maleate (Cream Versus Gel) for Insect Bites
Lead Sponsor:
Mantecorp Industria Quimica e Farmaceutica Ltd.
Conditions:
Insect Bites
Eligibility:
All Genders
2-60 years
Phase:
PHASE3
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. Dexchlor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01233934
Start Date
February 1 2011
End Date
July 1 2011
Last Update
November 3 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medcin Instituto da Pele Ltda.
Osasco, São Paulo, Brazil, 06023000