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Trial record 23 of 40 for:    Clotrimazole

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

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ClinicalTrials.gov Identifier: NCT00671528
Recruitment Status : Terminated (terminated early due to lack of recruitment [only 3 of 207 subjects were enrolled])
First Posted : May 5, 2008
Results First Posted : June 16, 2011
Last Update Posted : January 13, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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.
Total Total of all reporting groups

Baseline Measures
   Quadriderme® Cream   Betamethasone Diproprionate and Gentamicin Sulfate Cream   Betamethasone Diproprionate Cream   Total 
Overall Participants Analyzed 
[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

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. ]

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


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00671528     History of Changes
Other Study ID Numbers: P05134
EudraCT No.: 2007-004980-23
First Submitted: May 1, 2008
First Posted: May 5, 2008
Results First Submitted: May 19, 2011
Results First Posted: June 16, 2011
Last Update Posted: January 13, 2015