| May 1, 2008 |
| September 14, 2009 |
| July 2009 |
| October 2010 (final data collection date for primary outcome measure) |
| Percent improvement of individually measured signs of the disease (in a given target area) assessed objectively by the investigator according to predefined scales: 0 to 5 for Erythema, Vesiculation, Scaling, and Pruritis; 1 to 6 for Overall Assessment. [ Time Frame: Days 1, 8, 15, 21, and 28. ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00671528 on ClinicalTrials.gov Archive Site |
- The speed of action, measured as the number of days required to achieve total remission. [ Time Frame: Up to 28 days of treatment. ] [ Designated as safety issue: No ]
- Safety profile (adverse events, clinical laboratory tests, physical examination, and vital signs) [ Time Frame: For adverse events, up to 30 days after last dose of study medication; for clinical laboratory tests, Days 1 and 28; for physical examination and vital signs, Days 1, 8, 15, 21, and 28. ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM1) |
| Double-blind Evaluation of the Safety and Efficacy of Quadriderme® (Betamethasone Diproprionate, Clotrimazole and Gentamicin) Compared With Betamethasone Diproprionate Combined With Gentamicin Sulfate and With Betamethasone Diproprionate in the Treatment of Impetiginous Eczema |
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 diproprionate, clotrimazole and gentamicin sulfate)
- Arm B: Combination of betamethasone diproprionate cream and gentamicin sulfate cream
- Arm C: Betamethasone diproprionate cream
At 7 sites, in Portugal, a total of 207 subjects will be randomized using a 1:1:1 randomization ratio to receive one of the three possible treatments for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. Assessments will be made of level of improvement of the target area in each treatment group, number of days for total remission, and safety profile. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
- Dermatitis, Atopic
- Eczema, Atopic
- Skin Diseases, Eczematous
|
- Drug: Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)
- Drug: Cream (betamethasone diproprionate and gentamicin)
- Drug: Cream (betamethasone diproprionate)
|
- Experimental: QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)
- Active Comparator: Combination of betamethasone diproprionate cream and gentamicin sulfate cream
- Active Comparator: Betamethasone diproprionate cream
|
| |
| |
| Recruiting |
| 207 |
| October 2010 |
| October 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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 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 Criteria:
- Pregnant patients or women of childbearing age who are not using birth control methods considered reliable by the attending physician.
- Patients with a history of hypersensitivity to any of the components of the medication being studied.
- Patients in whom the extent or severity of the lesions requires treatment of a different type than what is planned for this trial.
- Patients who need any other type of topical or systemic medication during the trial that might affect the course of the disease.
- Patients who have been treated with other topical medications during the 14-day period prior to the start of the trial.
- Patients who have received systemic corticosteroids or any other immunosuppressant medication during the 28-day period prior to the start of the study.
|
| Both |
| 12 Years and older |
| No |
| Contact: SP Clinical Trial Registry Call Center |
1-888-772-8734 |
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| Portugal |
| |
| NCT00671528 |
| Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| P05134, EudraCT No.: 2007-004980-23 |
| Schering-Plough |
|
|
| Schering-Plough |
| September 2009 |