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

This study has been terminated.

( terminated early due to lack of recruitment [only 3 of 207 subjects were enrolled] )

Study NCT00671528 Information provided by Schering-Plough

First Received on May 1, 2008. Last Updated on May 19, 2011 History of Changes

Results First Received: May 19, 2011

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
Conditions:	Dermatitis, Atopic Eczema, Atopic Skin Diseases, Eczematous
Interventions:	Drug: Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) Drug: Cream (betamethasone diproprionate and gentamicin) Drug: Cream (betamethasone diproprionate)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Due to lack of recruitment, the study was terminated early. Only 3 participants of the anticipated 207 participants were enrolled.

Reporting Groups

	Description
Quadriderme® Cream	Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% 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.
Betamethasone Diproprionate and Gentamicin Sulfate Cream	Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% 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.
Betamethasone Diproprionate Cream	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.

Participant Flow: Overall Study

	Quadriderme® Cream	Betamethasone Diproprionate and Gentamicin Sulfate Cream	Betamethasone Diproprionate Cream
STARTED	1	1	1
COMPLETED	1	1	1
NOT COMPLETED	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Quadriderme® Cream	Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% 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.
Betamethasone Diproprionate and Gentamicin Sulfate Cream	Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% 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.
Betamethasone Diproprionate Cream	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.

Baseline Measures

	Quadriderme® Cream	Betamethasone Diproprionate and Gentamicin Sulfate Cream	Betamethasone Diproprionate Cream	Total
Number of Participants [units: participants]	1	1	1	3
Age, Customized [units: participants]
Between 18 and 65 years	0	0	1	1
>=65 years	1	1	0	2
Gender [units: participants]
Female	1	0	1	2
Male	0	1	0	1

Outcome Measures

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1. Primary:

Percent Improvement of Individually Measured Signs of the Disease [ Time Frame: Days 1 (prior to start of treatment), 8, 15, 21, and 28. ]

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2. Secondary:

Number of Days Required to Achieve Total Remission [ Time Frame: Up to 28 days ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The principal investigators agree not to publish or publicly present any interim results of the study without prior written consent of the SPONSOR. The principal investigator further agrees to provide 45 days written notice to the sponsor prior to submission for publication or presentation to permit the SPONSOR to review copies of abstracts or manuscripts for publication which report any results of the study. The SPONSOR shall have the right to review and comment on any presentation.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was terminated early due to lack of recruitment (only 3 of 201 participants were enrolled). Statistical analyses were not performed.

Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com

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