Status:
UNKNOWN
Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Gel) in the Relief of Sunburn Related Symptoms
Lead Sponsor:
Mantecorp Industria Quimica e Farmaceutica Ltd.
Conditions:
Sunburn
Eligibility:
All Genders
2-60 years
Phase:
PHASE3
Brief Summary
Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation ap...
Eligibility Criteria
Inclusion
- Signs of solar erythema of mild to moderate intensity resulting from voluntary exposure to sun within the last 72 hours
- 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
- Signs of severe sunburn (vesicles, bullae or ulceration)
- Use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study
- History of atopy or allergic diseases
- History of allergy to 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 :
124 Patients enrolled
Trial Details
Trial ID
NCT01237925
Last Update
November 10 2010
Active Locations (1)
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1
Medcin Instituto da Pele Ltda
Osasco, São Paulo, Brazil, 06023-000