Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4)(COMPLETED) - Full Text View

Sponsor:	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.

Note: This study was terminated early due to lack of recruitment (only 3 of the 207 planned participants were enrolled). Statistical analyses were not performed.

Further, 7 sites were planned, but only 4 sites were approved out of which 3 sites were initiated.

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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 [ Time Frame: Days 1 (prior to start of treatment), 8, 15, 21, and 28. ] [ Designated as safety issue: No ]
Percent improvement of individually measured signs of the disease (erythema, vesiculation, scaling, pruritis) in a given target area that was chosen by the investigator was assessed objectively & quantified on a scale of 0-5 (0-absent, 5-very intense). Overall assessment reflected the changes in the disease & was carried out by the investigator.

The following scale was used:
1. Cure- Complete remission
2. > 75% reduction: Marked improvement
3. 50-75% reduction: Moderate improvement
4. 25-50% reduction: Slight improvement
5. <25% reduction: Ineffectiveness
6. Worsening of signs & symptoms

Secondary Outcome Measures:

Number of Days Required to Achieve Total Remission [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
The speed of action, measured as the number of days required to achieve total remission of all signs and symptoms of the disease.

Enrollment:	3
Study Start Date:	July 2009
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: QUADRIDERME® cream QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)	Drug: Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% cream applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), 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. Other Name: QUADRIDERME® cream, SCH 000411
Active Comparator: Betamethasone and Gentamicin Combination of betamethasone diproprionate cream and gentamicin sulfate cream	Drug: Cream (betamethasone diproprionate and gentamicin) Betamethasone diproprionate 0.05% and gentamicin sulfate 0.1% cream applied in a thin layer that covers the affected and surrounding area BID, 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.
Active Comparator: Betamethasone Betamethasone diproprionate cream	Drug: Cream (betamethasone diproprionate) Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, 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 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 Criteria:

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00671528 History of Changes
Other Study ID Numbers:	P05134, EudraCT No.: 2007-004980-23
Study First Received:	May 1, 2008
Results First Received:	May 19, 2011
Last Updated:	May 19, 2011
Health Authority:	Portugal: National Pharmacy and Medicines Institute

Keywords provided by Schering-Plough:

Impetiginous

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Clotrimazole
Miconazole

Gentamicins
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012