Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT01567995
Eligibility Criteria:
Inclusion Criteria:
* Subjects with a diagnosis of eczema, fulfil the 3 follow items: 1) Erythema, papilla/water blister, Lichenification, skin damage with infiltration, 2) unknown reason, recurrent attacks; 3) itching in diseased skin
* Subjects must have body surface area (BSA) disease involvement of less than or equal to 10% as assessed by palm method
* Subject must present with moderate and above eczema as defined by a score greater than or equal to 3 using the investigators global assessment (IGA) of eczema severity.
Exclusion Criteria:
* The subject presents with any systemic disorder or active skin disease (e.g. psoriasis) that would in any way confound interpretation of the study results or subjects who present with scars, moles, tattoos, body piercings, sunburn in the test area which could interfere with the assessment of lesions at screening.
* The subject has eczema restricted to the face, the feet or the hands only.
* The subject is indicated any anti-infectives drug for a current complication of overt bacterial, fungal and viral infection
* History of recent (\<1 month) active or presence of current superficial skin infections of viral aetiology such as herpes simplex, or varicella.
* The subject has been exposed to below therapy within the set timeframe: Topical agents administered in the diseased skin, including emollient - 1 week; Systemic administration of anti-histamine agents - 2 week; Systemic administration of corticosteroid -4 week; Systemic administration of immunosuppressive drugs - 4 week; UV therapy -4 week
* Foreseeable intensive ultraviolet (UV) exposure during the study (solar or artificial). Subjects must not be exposed to intense direct sunlight for long periods, and must not use skin tanning devices (e.g. sunbed) for the duration of the study.
* History of clinically significant cardiovascular, pulmonary, gastrointestinal, liver, neurological, renal or haematological abnormalities.
* History of allergy to components of test medications to be used in the study.
* History of anaphylaxis (a sudden, potentially life-threatening systemic allergic reaction) to food, medications, insect venom, or latex.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
65 Years
Study:
NCT01567995
Study Brief:
Protocol Section:
NCT01567995