Trial record 4 of 3012 for:    Open Studies | "Skin Diseases"

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 is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01915914
First received: June 27, 2013
Last updated: August 21, 2014
Last verified: August 2014
  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:
  • Compare the time to the first relapse of AD during MAINTENANCE phase between emollient twice daily plus FP 0.05% cream once daily twice a week and emollient twice daily [ Time Frame: Participants will be followed during MAINTENANCE phase (up to 20 weeks) ] [ Designated as safety issue: No ]
    Primary endpoint in this study is to compare the time to the first relapse of AD during MAINTENANCE phase between emollient twice daily plus FP 0.05% cream once daily twice a week and emollient twice daily.


Secondary Outcome Measures:
  • Median time to the first relapse of AD during maintenance phase and follow-up phase. [ Time Frame: Participants will be followed during maintenance phaseand follow-up phase (up to 32 weeks) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: December 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 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
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

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
China, Guangdong
GSK Investigational Site Recruiting
Shenzhen, Guangdong, China, 518038
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
China, Hunan
GSK Investigational Site Recruiting
Changsha, Hunan, China, 410007
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
China
GSK Investigational Site Recruiting
Beijing, China
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Shanghai, China, 200092
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01915914     History of Changes
Other Study ID Numbers: 117291
Study First Received: June 27, 2013
Last Updated: August 21, 2014
Health Authority: China: Ethics Review Board

Additional relevant MeSH terms:
Skin Diseases
Skin Diseases, Genetic
Skin Diseases, Eczematous
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
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 August 26, 2014