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Trial record 4 of 32 for:    Clotrimazole AND day

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.

Tracking Information
First Submitted Date  ICMJE May 1, 2008
First Posted Date  ICMJE May 5, 2008
Results First Submitted Date  ICMJE May 19, 2011
Results First Posted Date  ICMJE June 16, 2011
Last Update Posted Date January 13, 2015
Study Start Date  ICMJE July 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2011)
Percent Improvement of Individually Measured Signs of the Disease [ Time Frame: Days 1 (prior to start of treatment), 8, 15, 21, and 28. ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2008)
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. ]
Change History Complete list of historical versions of study NCT00671528 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2011)
Number of Days Required to Achieve Total Remission [ Time Frame: Up to 28 days ]
The speed of action, measured as the number of days required to achieve total remission of all signs and symptoms of the disease.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2008)
  • The speed of action, measured as the number of days required to achieve total remission. [ Time Frame: Up to 28 days of treatment. ]
  • 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. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4)
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Dermatitis, Atopic
  • Eczema, Atopic
  • Skin Diseases, Eczematous
Intervention  ICMJE
  • 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
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: QUADRIDERME® cream
    QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)
    Intervention: Drug: Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)
  • Active Comparator: Betamethasone and Gentamicin
    Combination of betamethasone diproprionate cream and gentamicin sulfate cream
    Intervention: Drug: Cream (betamethasone diproprionate and gentamicin)
  • Active Comparator: Betamethasone
    Betamethasone diproprionate cream
    Intervention: Drug: Cream (betamethasone diproprionate)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 19, 2011)
3
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2008)
207
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Portugal
 
Administrative Information
NCT Number  ICMJE NCT00671528
Other Study ID Numbers  ICMJE P05134
EudraCT No.: 2007-004980-23
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP