Combination Therapy for Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      Atopic dermatitis is a chronic relapsing disease with acute flares. The standard therapy is
      to treat acute flares using topical medications. The two most common classes of topical
      medications for atopic dermatitis (AD) are topical corticosteroids and topical calcineurin
      inhibitors.

      Pimecrolimus and topical corticosteroids exert their activity by different mechanisms, there
      may be a synergistic effect of the combination therapy. Therefore, a combination therapy may
      provide a faster resolution of severe skin lesions and consequently reduce the duration of
      the topical corticosteroid treatment. Another benefit of the combination therapy maybe the
      use of a lower potency corticosteroid to achieve the same degree of clearance.

      The hypothesis of this trial is that the combination of the two agents will lead to faster
      clearance than the single agent of topical corticosteroids.
    

Detailed description: 
      This trial is a double-blind controlled trial of fluticasone cream daily and pimecrolimus
      cream BID versus fluticasone cream daily and placebo cream BID for the treatment of acute
      flares of atopic dermatitis.

      While pimecrolimus cream 1% has been proven to be effective in mild and moderate Atopic
      dermatitis (AD), there is a need for a fast control of severe skin lesions. On the other
      hand, reducing the duration of the topical corticosteroid treatment is a reasonable approach
      to minimize the occurrence of adverse effects.

      Because pimecrolimus and topical corticosteroids exert their activity by different
      mechanisms, there may be a synergistic effect of the combination therapy. Therefore, a
      combination therapy may provide a faster resolution of severe skin lesions and consequently
      reduce the duration of the topical corticosteroid treatment. Another benefit of the
      combination therapy maybe the use of a lower potency corticosteroid to achieve the same
      degree of clearance.

      In vitro data have demonstrated that a combination of steroids and tacrolimus has synergistic
      effects on in vitro human lymphocyte proliferation. In addition, it has previously been
      reported, in a pilot investigation in two subjects, that a combination regimen of
      pimecrolimus 1% twice a day and fluticasone propionate cream 0.05% once daily was superior to
      fluticasone propionate cream 0.05% once daily in the acute treatment of atopic dermatitis
      (AD).

      This study is conducted to validate these findings in a larger number of patients.
    

Intervention name(s): Combination of pimecrolimus and fluticasone; pimecrolimus
Intervention type(s): Drug; Drug
Intervention description(s): Pimecrolimus cream twice a day and fluticasone cream once a day; apply daily with fluticasone cream for flares
Other intervention name(s): Pimecrolimus cream; fluticasone
Intervention MeSH terms: Fluticasone; Xhance; Pimecrolimus; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: THerapy for acute moderate to severe flares