Dermatitis Study

Phase 1

Conditions: stabilized atopic dermatitis
MedDRA version: 20.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000018018
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2017-001574-42-Outside-EU/EEA

Lead Sponsor: GlaxoSmithKline Research & Development Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 123

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 (Appendix 10.3);

3. Mild to moderate AD on the head/neck, trunk, upper limbs or lower limbs and PSGA scores 2-3 (six-point scale of PSGA described in Appendix 10.5)

4. The informed consent must be signed before any study specific tests or procedures are initiated; As the subjects are children mainly, special requirement of informed consent is described in 9.2;

Subjects eligible for enrolment in the MAINTENANCE phase of the study must meet all of the following criteria:

5. Achieve treatment success as defined in section 6.2.1 after receiving Fluticasone propionate 0.05% cream twice daily up to 4 weeks in ACUTE phase.
Are the trial subjects under 18? yes
Number of subjects for this age range: 123
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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:
2. Dermatitis of only the face, feet or hands;

3. The involved area has exceeded 10% of the whole body area;

4. Diagnosed contact dermatitis at predilection sites of AD;

5. Atrophy, telangiectasia, extensive scarring lesions in the area or areas to be treated;

6. Had topical therapies including but not limit to calcineurin inhibitors (topical tacrolimus or topical pimecrolimus), corticosteroids, antihistamines within 14 days prior to screening;

7. 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;

8. Pregnant or breast-feeding. Women of Childbearing Potential (WOCBP) with a positive urine pregnancy test performed within 7 days before the start of treatment;

9. Has immunocompromised disease (e.g. lymphoma, AIDS, Wiskott-Aldrich syndrome) or have a history of malignancy (including basal cell carcinoma, squamous cell carcinoma, melanoma);

10. Has open skin infections (bacterial, viral or fungal) if at the application site;

11. Has head lice or scabies;

12. Present with clinical conditions other than AD that may interfere with the valuation (e.g. generalized erythrodema, toxicoderma, acne, Netherton’s Syndrome, psoriasis);

13. 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;

14. Has accepted any experimental or investigational drug or therapy within 6 weeks prior to screening;

15. Has known hypersensitivity to Fluticasone Propionate 0.05% cream, or Physiogel lotion, or relate drugs;

16. 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;

17. Drug abuse, mental dysfunction, or other factors limiting the subject’s ability to cooperate fully with study-related procedures;

18. Know to be unreliable or may be unable to complete the study;

19. Any condition or prior/present treatment that would render the subject not eligible for the study;

Maintenance phase:

20. Accepted topic therapies other than Fluticasone propionate 0.05% cream and emollients during the ACUTE phase;

21. Has active skin infection (bacterial, viral or fungal).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study is aimed to demonstrate the risk of AD relapse can be significantly reduced by extended intermittent dosing with Fluticasone propionate (FP) 0.05% cream in addition to regular emollient therapy (Physiogel lotion) in the maintenance treatment (20 weeks) of atopic dermatitis (AD) as compared with application of emollient alone.;Secondary Objective: The secondary objective is to evaluate the safety of FP 0.05% cream and emollient combination usage in AD maintenance treatment and determine the optimal treatment regimen in Chinese paediatric patients with AD.;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: FOLLOW-UP phase will be assessed every 4 weeks up to 12 weeks or until AD relapse defined in 6.2.1 dependent on which time point comes first.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The following measurements will be assessed as secondary efficacy endpoints:<br>1) Median time to the first relapse of AD during the whole study (including maintenance phase and follow-up phase.<br>2) Numbers of recurrent patients at the end of MAINTENANCE phase;<br>3) Numbers of recurrent patients at the end of FOLLOW-UP phase;<br>4) The effective rates (proportion of treatment success” patients) during ACUTE phase (V3, W-2±2days;V4, W0±2days )<br>5) The change of Quality of Life (QoL) from baseline at the end of MAINTENANCE phase;<br>6) The change of Quality of Life (QoL) from baseline at the end of FOLLOW-UP phase;<br>7) Subjects’ post-study evaluation to drugs (including FP 0.05% cream and emollient, Appendix 10.10);Timepoint(s) of evaluation of this end point: FOLLOW-UP phase will be assessed every 4 weeks up to 12 weeks or until AD relapse defined in 6.2.1 dependent on which time point comes first.