Status:
TERMINATED
Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4)
Lead Sponsor:
Organon and Co
Conditions:
Dermatitis, Atopic
Eczema, Atopic
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
This is a parallel-group, randomized, active-controlled, double-blind, Phase 4 trial comparing three creams in the treatment of impetiginous eczema: * Arm A: QUADRIDERME® cream (betamethasone dipropr...
Eligibility Criteria
Inclusion
- Minimum age: 12 years
- Good general health confirmed by clinical history and a physical and skin examination (excluding area of skin with impetiginous eczema).
- Diagnosis of impetiginous eczema.
- Ability to understand the procedures of the protocol and follow the requirements during the course of the study.
- Results of routine laboratory tests - hemogram with leukogram and platelet count, creatinine, glucose, sed. rate, IgE level and transaminases; along with plasma cortisol and adrenocorticotropic hormone (ACTH) levels prior to the start of the treatment. These results must all be within normal limits or not clinically relevant in order to be included in the trial.
Exclusion
- Pregnant participants or women of childbearing age who are not using birth control methods considered reliable by the attending physician.
- Participants with a history of hypersensitivity to any of the components of the medication being studied.
- Participants in whom the extent or severity of the lesions requires treatment of a different type than what is planned for this trial.
- Participants who need any other type of topical or systemic medication during the trial that might affect the course of the disease.
- Participants who have been treated with other topical medications during the 14-day period prior to the start of the trial.
- Participants who have received systemic corticosteroids or any other immunosuppressant medication during the 28-day period prior to the start of the study.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00671528
Start Date
July 1 2009
End Date
May 1 2010
Last Update
February 9 2022
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