Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM1) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00671528

Purpose

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.

Condition	Intervention	Phase
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)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Eczema Skin Conditions

Drug Information available for: Miconazole nitrate Miconazole Clotrimazole Bentelan Betamethasone Gentamicins Betamethasone dipropionate

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	207
Study Start Date:	July 2009
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm A: Experimental QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)	Drug: Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) Cream [betamethasone 0.05% (in the form of diproprionate), clotrimazole 1%, and gentamicin 0.1% (in the form of sulfate)] applied in a thin layer that covers the affected and surrounding area 2 times a day, morning and night 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.
Arm B: Active Comparator Combination of betamethasone diproprionate cream and gentamicin sulfate cream	Drug: Cream (betamethasone diproprionate and gentamicin) Cream [betamethasone 0.05% (in the form of diproprionate) and gentamicin 0.1% (in the form of sulfate)] applied in a thin layer that covers the affected and surrounding area 2 times a day, morning and night 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.
Arm C: Active Comparator Betamethasone diproprionate cream	Drug: Cream (betamethasone diproprionate) Cream [betamethasone 0.05% (in the form of diproprionate)] applied in a thin layer that covers the affected and surrounding area 2 times a day, morning and night 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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671528

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Portugal
Investigational Site 6	Recruiting
Lisboa, Portugal, 1069-166

Sponsors and Collaborators

Schering-Plough

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05134, EudraCT No.: 2007-004980-23
Study First Received:	May 1, 2008
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00671528 History of Changes
Health Authority:	Portugal: National Pharmacy and Medicines Institute

Keywords provided by Schering-Plough:

Impetiginous

Study placed in the following topic categories:

Betamethasone-17,21-dipropionate
Anti-Inflammatory Agents
Anti-Infective Agents
Dermatitis, Atopic
Clotrimazole
Miconazole
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Eczema
Hormones
Anti-Bacterial Agents
Hypersensitivity
Antifungal Agents

Skin Diseases, Eczematous
Skin Diseases, Genetic
Betamethasone
Dermatitis
Skin Diseases
Betamethasone sodium phosphate
Anti-Asthmatic Agents
Glucocorticoids
Anti-Infective Agents, Local
Sodium phosphate
Genetic Diseases, Inborn
Gentamicins
Hypersensitivity, Immediate

Additional relevant MeSH terms:

Betamethasone-17,21-dipropionate
Anti-Inflammatory Agents
Anti-Infective Agents
Respiratory System Agents
Dermatitis, Atopic
Molecular Mechanisms of Pharmacological Action
Clotrimazole
Miconazole
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Eczema
Hormones
Anti-Bacterial Agents
Hypersensitivity
Antifungal Agents

Therapeutic Uses
Skin Diseases, Eczematous
Betamethasone
Skin Diseases, Genetic
Dermatitis
Immune System Diseases
Skin Diseases
Betamethasone sodium phosphate
Anti-Asthmatic Agents
Enzyme Inhibitors
Glucocorticoids
Pharmacologic Actions
Protein Synthesis Inhibitors
Anti-Infective Agents, Local
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 03, 2009