We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 : February 9, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment 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 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00671528    
Other Study ID Numbers: P05134
EudraCT No.: 2007-004980-23
First Posted: May 5, 2008    Key Record Dates
Results First Posted: June 16, 2011
Last Update Posted: February 9, 2022
Last Verified: February 2022
Keywords provided by Organon and Co:
Impetiginous
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Gentamicins
Clotrimazole
Miconazole
Betamethasone
Betamethasone Valerate
 Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action