Combination Therapy for Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Combination of pimecrolimus and fluticasone; pimecrolimus
Intervention description: Pimecrolimus cream twice a day and fluticasone cream once a day; apply daily with fluticasone cream for flares
Intervention MeSH terms: Fluticasone; Xhance; Pimecrolimus; Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 90.0
Sex: All
Minimum age: 2 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: THerapy for acute moderate to severe flares

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 2 to 65 years

          -  Clinical diagnosis of (Atopic Dermatitis) AD according to the American Academy of
             Dermatology (AAD) Consensus Conference (2001)

          -  At least two lesions of AD on symmetrical part of the body (same location for each
             side of the body), of severe intensity (m-EASI is at least 7 on each site, with
             erythema of at least 3 (severe) and papulation/infiltration of at least 3 (severe))
             and similar severity (m-EASI does not differ from more than 2 points on both sides)

          -  Signed written informed consent

          -  Willingness and ability to comply with the study requirements

          -  Female is able to enter and participate in this study if she is of:

               -  Non-childbearing potential (i.e., physiologically incapable of becoming pregnant)
                  or

               -  Childbearing potential, has a negative pregnancy test (urine) at the screen visit
                  and agrees to an adequate method of birth control throughout the study (which
                  may, at the investigator's discretion, include abstinence)

        Exclusion Criteria:

          -  History of immune deficiencies or history of malignant disease

          -  Patients with moderate to severe lichenification at the target areas (i.e. score 2 or
             3)

          -  Active cutaneous bacterial, viral or fungal infections in target areas

          -  History of other skin disorders, including Netherton syndrome, that could interfere
             with the evaluations

          -  Use of any topical treatment known or suspected to have an effect on atopic dermatitis
             within one week prior to the screen visit (except for calcineurin inhibitors, for
             which the washout is 2 weeks)

          -  Use of any systemic treatment (including phototherapy) known or suspected to have an
             effect on AD within four weeks prior to the screen visit [(patients on a stable and
             low dose of inhaled steroids, on a stable dose of anti histamines, on stable dose of
             leukotriene antagonists, or receiving occasional short-acting b2-agonists for the
             treatment of asthma and topical corticosteroids (nasal spray) for the treatment of
             allergic rhinitis may participate). High-dose inhaled corticosteroids (> 440 mcg of
             fluticasone a day) and anti-IgE products are not permitted].

          -  Known sensitivity to pimecrolimus or vehicle (placebo) or fluticasone propionate cream
             or any of their ingredients

          -  Patients with severe medical condition(s) that in the view of the investigator
             prohibits participation in the study

          -  Use of any other investigational agent in the last 30 days