2022-501184-41-00已完成4 期
A phase IV randomised, double-blind, parallel-design, controlled multi-center trial of a NOVel moisturiser for Atopic dermatitis: effect on relapse prevention in children, NOVA II
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 10
- 主要终点
- Relapse of atopic eczema, measured as a hazard ratio. Definition of relapse is an episode that, from the participants/participants’ parent(s) and/or legal guardian(s)’s perspective, requires escalation of treatment of the study area eczemas. Date of relapse will be noted in the eDiary and confirmed by the Investigator.
研究概览
简要总结
To demonstrate superiority of a newly developed moisturiser in preventing eczema relapse in children with AD compared to a reference cream.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Children >2- ≤12 years old (male and female)
- •Diagnosis of AD according to UK working party 1994,(32) i.e.: a) Any itching skin condition and b) Three or more of the following: (i) History of flexural involvement, e.g. front of elbows, behind the knees, front of ankles, around the neck (ii) Personal history of other atopic disease, e.g. asthma or hay fever (iii) History of generally dry skin in the last 12 months (iv) Visible flexural dermatitis, e.g. front of elbows, behind the knees, front of ankles, around the neck (v) Onset below age 2
- •Visible mild (≤ 15 ) to moderate (> 15 to < 40) eczema according to the objective SCORAD, which ideally should be symmetrical in localization and/or face.
- •Participants with at least two relapses during last 12 months, including the one at the screening visit
- •Participants willing to agree to avoid any other prescription/OTC/natural remedies treatments for eczema and/or dry skin
- •Legally acceptable representatives (i.e. parent(s) or guardians) of participant according to local regulations have provided the appropriate written informed consent and participant has given their assent (as age appropriate).
排除标准
- •Participants with severe eczema, as defined by objective SCORAD
- •Any treatment with immunomodulatory systemic medications, e.g. dupilumab, omalizumab or other biologics, JAK inhibitors, methotrexate, cyclosporine, oral or systemic corticosteroids (except inhaled corticoid spray for allergic asthma if on a stable dose and asthma status well controlled) within 3 months prior screening and throughout the study
- •Any treatment with TCS' (other than the corticosteroids prescribed in the stabilisation phase) or other established topical treatment for AD within 2 weeks prior screening and throughout the study.
- •Phototherapy (UVB, UVA, UVA1, PUVA) within 4 weeks prior screening and throughout the study
- •Moisturisers, home remedies or other topical products on the study area eczemas, except for the AxMP (during the stabilisation phase) and the IP in the maintenance phase.
- •Asthma which is not stable during the last 6 months prior screening as per clinical judgement (reflected by symptoms>2 days per week or nighttime awakening with symptoms > 2 times per week or reduced normal activities due to asthma, PEF <80% of predicted value)
- •Any infectious disease of the skin within 4 weeks prior screening
- •Viral diseases (e.g. chicken pocks, shingles), rosacea, perioral dermatitis, ulcers, acne vulgaris,skin atrophy, vaccination reaction in the treatment area
- •Skin infections caused by bacteria and fungi
- •Diaper rash in the treatment area
- •Any infectious disease including unexplained diarrhea within 2 weeks prior screening
- •Participants with eczema on the hands only
- •Any immunosuppression or history of unusual frequent, recurrent, severe or prolonged infections
- •History of immunomodulatory or immunosuppressant diseases e.g. lymphoproliferative diseases, diabetes mellitus, malignancies of any organ within 5 years prior screening
- •History of intolerance to topical corticosteroids or any condition which prohibits or does not recommend treatment with topical corticosteroids e.g. atrophy of the skin
- •Participants with known or suspected allergies or contraindications to any of the study product ingredients (including products for the treatment in the stabilization phase)
- •Participants/participants’ parent(s) and/or legal guardian(s) who, in the opinion of the Investigator, are unable to complete all study related visits and/or procedures.
- •Pregnancy confirmed by a positive human chorionic gonadotropin (hCG) urine test for females of childbearing potential
- •Enrolment in any investigational study or use of an investigational product (oral or topical) within 3 months prior to the screening visit
- •Planning to participate in any other clinical study during participation in this current study, including the maintenance phase.
- •Participants unwilling to refrain from using prohibited medication including moisturizers (other than the study treatments)
- •Antibiotic, antimycotic or antiviral treatment (oral or topical) within 2 weeks prior screening and throughout the study
结局指标
主要结局
Relapse of atopic eczema, measured as a hazard ratio. Definition of relapse is an episode that, from the participants/participants’ parent(s) and/or legal guardian(s)’s perspective, requires escalation of treatment of the study area eczemas. Date of relapse will be noted in the eDiary and confirmed by the Investigator.
Relapse of atopic eczema, measured as a hazard ratio. Definition of relapse is an episode that, from the participants/participants’ parent(s) and/or legal guardian(s)’s perspective, requires escalation of treatment of the study area eczemas. Date of relapse will be noted in the eDiary and confirmed by the Investigator.
次要结局
- Time to relapse of atopic eczema (days)
- Proportion of participants still eczema free after 1, 2, 3, 4, 5 and 6 months maintenance treatment
- Absolute and relative risk reduction
- Assessment of disease severity using PO-SCORAD, and POEM (visits 1-4)
- Assessment of peak itch intensity by VAS obtained from PO-SCORAD (Visits 1-4)
- Weekly assessment of disease severity by using RECAP during the maintenance phase
- Quality of life, assessed by disease specific instruments using IDQoL (below four years) or CDLQI (above four years) (Visits 1-4)
- Quality of life, assessed by general instrument EQ-5D-Y (participants above four years) (Visits 1-4)
- Cream consumption, based on weight of IP product before and after use (Visit 2 and Visit 4)
- Questionnaire for evaluation of cosmetic/organoleptic properties of the creams by participant or parents/guardians
- Questionnaire connected to microbiome for those consenting for microbiome swabbing
- Number of participants with FLG loss-of-function mutations and evidence of a relationship to treatment effects
- Tolerability, measured as smarting/stinging on a VAS immediately and 5 minutes after first application (V2) and after one week of treatment
- Number of participants with Treatment-Emergent Adverse Events (AEs) [Time Frame: Baseline (Day 1) up to Day 180/relapse]
研究者
Tina Holm
Scientific
Aco Hud Nordic AB
研究点 (10)
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