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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01915914
First received: June 27, 2013
Last updated: November 19, 2015
Last verified: October 2015
  Purpose

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.

Condition Intervention Phase
Skin Diseases
Drug: Fluticasone propionate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Time to the First Relapse of AD During the Maintenance Phase [ Time Frame: From the start of treatment up to Week 20 during the Maintenance Phase ] [ Designated as safety issue: No ]
    Time to the first relapse of AD is defined as the number of days from start of the FP treatment in Maintenance Phase until AD relapse. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success during Acute Phase. Participants with treatment success are defined as participants with PSGA <=1; and the improvement >=2 compared to Baseline.


Secondary Outcome Measures:
  • Median Time to the First Relapse of AD During the Maintenance Phase and Follow-up Phase [ Time Frame: From the start of treatment up to Week 32 during the Maintenance Phase and Follow-up Phase ] [ Designated as safety issue: No ]
    Median time to the first relapse of AD during the Maintenance Phase and Follow-up Phase is defined as the number of days from start of the FP treatment until AD relapse during the Maintenance Phase and Follow-up Phase. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success during the Acute Phase.

  • Numbers of Recurrent Participants at the End of the Maintenance Phase (Week 20) [ Time Frame: From Week 0 (or treatment success, if earlier) to Week 20 ] [ Designated as safety issue: No ]
    The number of participants with AD recurrent/relapse at the end of Maintenance Phase is presented. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success. Participants with treatment success is defined as participants with PSGA <=1; and the improvement >=2 compared to Baseline.

  • Numbers of Recurrent Participants at the End of the Follow-up Phase (Week 32) [ Time Frame: From Week 20 to Week 32 ] [ Designated as safety issue: No ]
    The number of participants with AD recurrent/relapse at the end of the Follow-up Phase is presented. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success. Participants with treatment success is defined as participants with PSGA <=1; and the improvement >=2 compared to Baseline.

  • Number of Participants With "Treatment Success" During the Acute Phase [ Time Frame: From the start of treatment up to Visit 4 (Week 0) or treatment success (depends on which time point comes first) ] [ Designated as safety issue: No ]
    The number of participants with "treatment success" during the Acute Phase is presented. Participants with treatment success are defined as participants with PSGA <=1; and the improvement >=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to Baseline in the Acute Phase of the study.

  • Change From Baseline in Quality of Life (QoL) at the End of the Maintenance Phase [ Time Frame: Baseline and Week 20 ] [ Designated as safety issue: No ]
    Infant's Dermatitis Quality of Life Index (IDQOL) and Children's Dermatology Life Quality Index (CDLQI) were used to evaluate quality of life for participants of age between 1 to 16 years. IDQOL and CDLQI questionnaires were designed for infants (below the age of 4 years) and children (age 4 to age 16) with atopic dermatitis, respectively. The IDQOL and CDLQI were calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. The change from Baseline in the QoL score is based on each questionnaire at the end of the Maintenance Phase and is calculated as the score at the end of the Maintenance Phase minus the Baseline score. Baseline is defined as QoL scores obtained at Visit 4 (end of Acute Phase). A QOL is equal to IDQOL if the age of a participant is < 4 years and it is equal to CDLQI if the age of a participant is between 4 and 16 years.

  • Change From Baseline in QoL at the End of the Follow-up Phase [ Time Frame: Baseline and Week 32 ] [ Designated as safety issue: No ]
    Infant's IDQOL and Children's CDLQI were used to evaluate quality of life for participants of age between 1 to 16 years. IDQOL and CDLQI questionnaires were designed for infants (below the age of 4 years) and children (age 4 to age 16) with AD, respectively. The IDQOL and CDLQI were calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. The change from Baseline in QoL score is based on each questionnaire at the end of the Follow-up Phase and is calculated as the score at the end of the Follow-up Phase minus the Baseline score. Baseline is defined as QoL scores obtained at Visit 4 (end of Acute Phase). A QOL is equal to IDQOL if the age of a participant is < 4 years and it is equal to CDLQI if the age of a participant is between 4 and 16 years.

  • Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire [ Time Frame: At early withdrawal or end of the therapy visit (up to Week 32) ] [ Designated as safety issue: No ]
    Participants from each group completed the post-study questionnaire to rate the skin emollients (gel, lotion, cream, ointment, solution and foam) used in the past based on their experience. Participants rated skin emollients on a 5-point scale (5= "liked the best", 4= "second best", 3= "third best", 2= "fourth best, 1= "liked the least", N/A=Does not apply to me).

  • Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire [ Time Frame: At early withdrawal or end of the therapy visit (up to Week 32) ] [ Designated as safety issue: No ]
    Participants from each group completed the post-study questionnaire to rate the qualities of the lotion as compared with other skin emollients used in the past based on their experience. Each participant was asked the following Questions (Q). Q 1: This product is easier to use than other skin emollients; Q 2: When I apply this product I am able to start my daily activities quicker than with other skin emollients; Q 3: This product leaves my skin feeling softer than other skin emollients; Q 4: I am able to apply this product to larger body surface areas than other skin emollients; Q 5: This product disappears into my skin quicker than when I apply other skin emollients. Participants rated the qualities of the lotion based on a 5 point scale (5= "Strongly Agree", 4= "Agree", 3= "Neutral", 2= "Disagree", 1= "Strongly Disagree" N/A=Does not apply to me). Participant's rating for each question were summarized.

  • Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire [ Time Frame: At early withdrawal or end of the therapy visit (up to Week 32) ] [ Designated as safety issue: No ]
    Participants from each group completed the post-study questionnaire to rate the qualities of the lotion as compared with other skin emollients used in the past based on their experience. Each participant was asked the following Questions (Q). Q 1: It leaves my skin feeling soft and smooth; Q 2: There is nothing left on my skin; Q 3: Does not feel greasy; Q 4: Disappears into my skin quickly after I put it on; Q 5: Easy to apply; Q 6: Fragrance-free; Q 7: Spreadability; Q 8: Lack of stickiness. Participants rated the qualities of the lotion based on a 5 point scale (5= "Strongly Agree", 4= "Agree", 3= "Neutral", 2= "Disagree", 1= "Strongly Disagree" N/A=Does not apply to me). Participant's rating for each question were summarized.

  • Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Acute Phase [ Time Frame: From the start of treatment up to Visit 4 (Week 0) or treatment success (depends on which time point comes first) ] [ Designated as safety issue: No ]
    Investigator evaluated and scored the signs of cutaneous atrophy (CA), epidermal thickening/lichenification (ET/L) and abnormal pigmentation (AP) using Visual Analogue Scale (ranging from 0 to 10, higher values represent a worse outcome) based on their subjective judgment. The change from Baseline in each signs (Cutaneous atrophy, epidermal thickening / lichenification and abnormal pigmentation) score at the end of the Acute Phase (Visit 4 [Week 0 or treatment success, depend on which time point comes first) ±2day]) and is calculated as the score at Visit 4 minus the Baseline score. Baseline is defined as the VAS score for each sign obtained before the first dose of study drug in the Acute Phase of the study (Visit 2). Summation of the VAS scores for each sign (CA, ET/L and AP) was done to calculate the Total VAS score (ranging from 0 to 30, higher values represent a worse outcome) at Visit 4 of the Acute Phase of the study.

  • Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Maintenance Phase and Follow-up Phase [ Time Frame: Baseline, Week 20 and Week 32 ] [ Designated as safety issue: No ]
    Investigator evaluated and scored the signs of cutaneous atrophy (CA), epidermal thickening/lichenification (ET/L) and abnormal pigmentation (AP) using the Visual Analogue Scale (ranging from 0 to 10, higher values represent a worse outcome) based on their subjective judgment. The change from Baseline in each sign (Cutaneous atrophy, epidermal thickening / lichenification and abnormal pigmentation) score at the end of the Maintenance Phase and Follow-up Phase and is calculated as the score at the end of the Maintenance and Follow-up Phase minus the Baseline score. Baseline is defined as VAS score for each sign obtained at Visit 4 (end of Acute Phase). Summation of VAS scores for each sign (CA, ET/L and AP) was done to calculate the Total VAS score (ranging from 0 to 30, higher values represent a worse outcome) at the Maintenance and Follow-up phase of study. The missing value was imputed using last-observation-carry-forward (LOCF) method.


Enrollment: 107
Study Start Date: December 2013
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fluticasone propionate
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
Drug: Fluticasone propionate
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.
Active Comparator: physiogel
To compare the efficacy and safety of fluticasone propionate 0.05% cream (twice per week) added to regular daily moisturization using Physiogel Lotion with Physiogel Lotion alone in paediatric subjects with stabilized atopic dermatitis
Drug: Fluticasone propionate
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915914

Locations
China, Guangdong
GSK Investigational Site
Shenzhen, Guangdong, China, 518038
China, Hunan
GSK Investigational Site
Changsha, Hunan, China, 410007
China
GSK Investigational Site
Beijing, China
GSK Investigational Site
Shanghai, China, 200092
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01915914     History of Changes
Other Study ID Numbers: 117291 
Study First Received: June 27, 2013
Results First Received: October 12, 2015
Last Updated: November 19, 2015
Health Authority: United States: Food and Drug Administration
China: Ethics Review Board

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on December 09, 2016