Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4)
Condition: Dermatitis, Atopic; Eczema, Atopic; Skin Diseases, Eczematous
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Eczematous
Intervention: Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate); Cream (betamethasone diproprionate and gentamicin); Cream (betamethasone diproprionate)
Intervention description: 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.; 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.; 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.
Intervention MeSH terms: Gentamicins; Clotrimazole; Miconazole; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Impetiginous

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.
    

Eligibility 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.