A Randomized, Open-label, Comparative Study to Evaluate an Intermittent Dosing Regimen of Fluticasone Propionate 0.05% Cream (Twice Per Week) in Reducing the Risk of Relapse When Added to Regular Daily Moisturization Using PHYSIOGEL Lotion in Paediatric Subjects With Stabilized Atopic Dermatitis
Condition: Skin Diseases
MeSH terms: Dermatitis, Atopic; Dermatitis; Skin Diseases
Intervention: Fluticasone propionate
Intervention description: All subjects receive FP 0.05% cream twice daily up to 4 weeks to all affected sites and any newly occurring sites in ACUTE phase. After randomization in MAINTENANCE phase, subjects either receive emollient (Physiogel) twice daily extendedly plus FP 0.05% cream once daily twice a week to all healed sites and any newly occurring sites (Group A), or emollient (Physiogel) twice daily extendedly (Group B), up to 20 weeks. In FOLLOW-UP phase, all subjects apply emollient (Physiogel) twice daily up to 12 weeks.
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open-label, randomized, comparative study, including 4 phases: SCREENING, ACUTE,
      MAINTENANCE and FOLLOW-UP.

      Subjects will complete the SCREENING phase to check the eligibility within 7 days after they
      sign the written informed consent form. All eligible subjects will be enrolled in ACUTE phase
      to receive twice daily Fluticasone propionate (FP) 0.05% cream up to 4 weeks. The efficacy
      and safety in ACUTE phase will be assessed every 2 weeks up to 4 weeks or until Treatment
      Success which depends on which time point comes first. Then subject can get into the
      MAINTENANCE phase receiving either emollient twice daily plus FP 0.05% cream once daily twice
      a week (Group A), or emollient twice daily (Group B), by 1:1 randomization. The treatment
      duration in MAINTENANCE phase will be up to 20 weeks. The efficacy and safety in MAINTENANCE
      phase will be assessed every 4 weeks up to 20 weeks or until AD relapse that depends on which
      time point comes first. If subjects don't experience relapse during MAINTENANCE phase,
      subsequent FOLLOW-UP phase applying emollient twice daily won't be longer than another 12
      weeks.

      Total study duration is up to 37 weeks. All subjects receive FP 0.05% cream twice daily up to
      4 weeks to all affected sites and any newly occurring sites in ACUTE phase. After
      randomization in MAINTENANCE phase, subjects either receive emollient twice daily extendedly
      plus FP 0.05% cream once daily twice a week to all healed sites and any newly occurring sites
      (Group A), or emollient twice daily extendedly (Group B), up to 20 weeks. In FOLLOW-UP phase,
      all subjects apply emollient twice daily up to 12 weeks.

      This study will enrol 120 subjects, and propose at least 80 subjects to be randomized.

      Study Endpoints/Assessments:

      Primary endpoint is to observe the median time to the first relapse of AD during MAINTENANCE
      phase.

      Secondary endpoints are:

        1. Median time to the first relapse of AD during the whole study (including maintenance
           phase and follow-up phase.

        2. Numbers of recurrent patients at the end of MAINTENANCE phase;

        3. Numbers of recurrent patients at the end of FOLLOW-UP phase;

        4. The effective rates (proportion of "treatment success" patients) during ACUTE phase (V3,
           W-2±2days;V4, W0±2days )

        5. Evaluate the safety during the whole study duration (ACUTE phase, MAINTENANCE phase,
           FOLLOW-UP phase respectively);

        6. Evaluate visual skin assessment for signs of cutaneous atrophy, epidermal thickening /
           lichenification and abnormal pigmentation changes during the whole study duration (ACUTE
           phase, MAINTENANCE phase, FOLLOW-UP phase respectively);

        7. The change of Quality of Life (QoL) from baseline at the end of MAINTENANCE phase;

        8. The change of Quality of Life (QoL) from baseline at the end of FOLLOW-UP phase;

        9. Subjects' post-study evaluation to drugs.
    

Eligibility criteria:

        Inclusion Criteria:

        Specific information regarding warnings, precautions, contraindications, adverse events,
        and other pertinent information on the GSK investigational product or other study treatment
        that may impact subject eligibility is provided in the package insert of CUTIVATE and
        PHYSIOGEL Lotion.

        Deviations from inclusion criteria are not allowed because they can potentially jeopardize
        the scientific integrity of the study, regulatory acceptability or subject safety.
        Therefore, adherence to the criteria as specified in the protocol is essential. Subjects
        eligible for enrolment in the study must meet all of the following criteria:

          1. male or female patients age between 1 to 18 years old (including 1 year and excluding
             18 years old);

          2. Diagnose atopic dermatitis according to criteria of Williams;

          3. Mild to moderate AD on the head/neck, trunk, upper limbs or lower limbs and PSGA
             scores 2-3;

          4. The informed consent must be signed before any study specific tests or procedures are
             initiated;

             Subjects eligible for enrolment in the MAINTENANCE phase of the study must meet all of
             the following criteria:

          5. Achieve treatment success after receiving Fluticasone propionate 0.05% cream twice
             daily up to 4 weeks in ACUTE phase

        Exclusion Criteria:

        Deviations from exclusion criteria are not allowed because they can potentially jeopardize
        the scientific integrity of the study, regulatory acceptability or subject safety.
        Therefore, adherence to the criteria as specified in the protocol is essential.

        Subjects meeting any of the following criteria must not be enrolled in the study:

        Acute phase:

          1. Dermatitis of only the face, feet or hands;

          2. The involved area has exceeded 10% of the whole body area;

          3. Diagnosed contact dermatitis at predilection sites of AD;

          4. Atrophy, telangiectasia, extensive scarring lesions in the area or areas to be
             treated;

          5. Had topical therapies including but not limit to calcineurin inhibitors (topical
             tacrolimus or topical pimecrolimus), corticosteroids, antihistamines within 14 days
             prior to screening;

          6. Has accepted nonsteroidal immunosuppressants (eg cyclosporine, methotrexate), or
             ultraviolet light treatments including ultraviolet-A and ultraviolet-B, or systemic
             corticosteroids regardless administration by oral, intramuscular, or intravenous
             within 4 weeks prior to screening;

          7. Pregnant or breast-feeding. Women of Childbearing Potential (WOCBP) with a positive
             urine pregnancy test performed within 7 days before the start of treatment;

          8. Has immunocompromised disease (e.g. lymphoma, AIDS, Wiskott-Aldrich syndrome) or have
             a history of malignancy (including basal cell carcinoma, squamous cell carcinoma,
             melanoma);

          9. Has open skin infections (bacterial, viral or fungal) if at the application site;

         10. Has head lice or scabies;

         11. Present with clinical conditions other than AD that may interfere with the valuation
             (e.g. generalized erythrodema, toxicoderma, acne, Netherton's Syndrome, psoriasis);

         12. Require systemic therapy for the treatment of atopic dermatitis, or had systemic
             therapy including but not limit to antihistamines within 14 days prior to screening;

         13. Has accepted any experimental or investigational drug or therapy within 6 weeks prior
             to screening;

         14. Has known hypersensitivity to Fluticasone Propionate 0.05% cream, or PHYSIOGEL lotion,
             or relate drugs;

         15. Non-compliance with general medical treatment, or are known to miss appointments, or
             don't intend to comply with the protocol for the duration of the study;

         16. Drug abuse, mental dysfunction, or other factors limiting the subject's ability to
             cooperate fully with study-related procedures;

         17. Know to be unreliable or may be unable to complete the study;

         18. Any condition or prior/present treatment that would render the subject not eligible
             for the study;

             Maintenance phase:

         19. Accepted topic therapies other than Fluticasone propionate 0.05% cream and emollients
             during the ACUTE phase;

         20. Has active skin infection (bacterial, viral or fungal).