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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)
Enrollment 3
Recruitment Details  
Pre-assignment Details Due to lack of recruitment, the study was terminated early. Only 3 participants of the anticipated 207 participants were enrolled.
Arm/Group Title Quadriderme® Cream Betamethasone Diproprionate and Gentamicin Sulfate Cream Betamethasone Diproprionate Cream
Hide Arm/Group Description 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. 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 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.
Period Title: Overall Study
Started 1 1 1
Completed 1 1 1
Not Completed 0 0 0
Arm/Group Title Quadriderme® Cream Betamethasone Diproprionate and Gentamicin Sulfate Cream Betamethasone Diproprionate Cream Total
Hide Arm/Group Description 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. 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 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 of all reporting groups
Overall Number of Baseline Participants 1 1 1 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 3 participants
Between 18 and 65 years 0 0 1 1
>=65 years 1 1 0 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 3 participants
Female
1
 100.0%
0
   0.0%
1
 100.0%
2
  66.7%
Male
0
   0.0%
1
 100.0%
0
   0.0%
1
  33.3%
1.Primary Outcome
Title Percent Improvement of Individually Measured Signs of the Disease
Hide Description

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
Time Frame Days 1 (prior to start of treatment), 8, 15, 21, and 28.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to lack of participant recruitment and therefore study termination, no analyses were performed.
Arm/Group Title Quadriderme® Cream Betamethasone Diproprionate and Gentamicin Sulfate Cream Betamethasone Diproprionate Cream
Hide Arm/Group Description:
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.
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 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.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Days Required to Achieve Total Remission
Hide Description The speed of action, measured as the number of days required to achieve total remission of all signs and symptoms of the disease.
Time Frame Up to 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quadriderme® Cream Betamethasone Diproprionate and Gentamicin Sulfate Cream Betamethasone Diproprionate Cream
Hide Arm/Group Description:
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.
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 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.
Overall Number of Participants Analyzed 1 1 1
Measure Type: Number
Unit of Measure: Days
15 15 8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quadriderme® Cream Betamethasone Diproprionate and Gentamicin Sulfate Cream Betamethasone Diproprionate Cream
Hide Arm/Group Description 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. 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 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.
All-Cause Mortality
Quadriderme® Cream Betamethasone Diproprionate and Gentamicin Sulfate Cream Betamethasone Diproprionate Cream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quadriderme® Cream Betamethasone Diproprionate and Gentamicin Sulfate Cream Betamethasone Diproprionate Cream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quadriderme® Cream Betamethasone Diproprionate and Gentamicin Sulfate Cream Betamethasone Diproprionate Cream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%) 
This study was terminated early due to lack of recruitment (only 3 of 201 participants were enrolled). Statistical analyses were not performed.
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 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.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
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