Status:
UNKNOWN
Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Insect Bite Related Symptoms
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 :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00995397
Last Update
October 22 2009
Active Locations (1)
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1
Medcin Instituto da Pele Ltda.
Osasco, São Paulo, Brazil, 06023-000