EUCTR2017-001574-42-Outside-EU/EEA进行中（未招募）1 期
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 - physiogel lotion with or without FP in AD patients
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 123
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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).
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