EUCTR2011-004184-79-GB进行中（未招募）1 期
A placebo controlled evaluation of a developmental gel for the treatment of atopic eczema - NIAD-01: A topical gel for the treatment of atopic eczema
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 54
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
入选标准
- •i) Male or female patients aged 16 years or older.
- •ii) Diagnosed as having atopic eczema as determined according to the UK Working Party's Diagnostic Criteria.
- •iii) Experiencing a mild to moderate acute episode (or flare) including bilaterally symmetrical involvement of the volar aspects of the forearms (including the flexures), presenting a local Investigator Global Assessment (IGA) score of 2 or 3 (see section 1.9) and an involvement area of at least 20 to 25 cm2 (approximately half of the size of a credit card).
- •iv) Willing to refrain from using any other topical treatments as well as emollients or moisturisers on the entire area of the volar forearms (from the front of the wrists to just above the creases of the elbows) for the next 29 days. Patients will be permitted to continue using prescribed topical treatments required for managing atopic eczema (including topical immunosuppressants) in other non-study areas of the body.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •i) Patients with a history of intolerance or skin sensitivity to any of the ingredients.
- •ii) Patients with systemic diseases which, in the opinion of the Investigator, may adversely influence their participation in the trial.
- •iii) Patients with severe atopic eczema (IGA=4) and/or with any active skin infections in the selected target areas.
- •iv) Patients with more than 20% of total body surface area of involvement (i.e. area equivalent to the whole of both arms or the whole of one leg).
- •v) Patients who have had phototherapy (UVB, PUVA) or systemic therapy with corticosteroids and / or other immunosuppressants, or cytostatics, within 4 weeks prior to screening.
- •vi) Patients who have taken systemic antibiotics within 2 weeks prior to screening.
- •vii) Patients who have applied topical treatments (e.g. tar, corticosteroids) on the study areas within 7 days prior to screening (with the exception of topically applied emollients).
- •viii) Patients receiving other medication known to alter the course of atopic eczema during the study (e.g. oral corticosteroids and/or other oral immunosuppressants).
- •ix) Patients who have received any unlicensed drug within the last 30 days or who are scheduled to receive an investigative drug other than the study medication during the period of the study.
- •x) Female patients who are pregnant, attempting to conceive or not currently using a contraceptive, or lactating (although there are no particular safety concerns in these patient groups, it is generally inappropriate for them to participate in clinical trials without overriding justification. Negative pregnancy testing will not be necessary, and there are no safety concerns, as such, about female subjects potentially conceiving while taking part in the study).
- •xi) Patients considered unable or unlikely to attend the necessary follow-up visits.
- •xii) Patients with another member of the household already enrolled in the study (this is to avoid possible mix up between assigned treatments).
- •xiii) Patients with tattoos, scars and/or birthmarks on the study treatment areas, which could potentially interfere with the visual assessments and/or the objective skin measurements performed in this study.
- •xiv) Patients with temporary or permanent impaired function of either left or right hands/arms such that they would be unable to apply the test products correctly to both arms themselves, and who cannot rely on external help (e.g. a relative or carer) to do so for them.
- •xv) Employees of Alba Science or Dermal Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling’s offspring) of such employees.
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