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 @ 9:37 PM
Ignite Modification Date:
2025-12-24 @ 9:37 PM
NCT ID:
NCT03395132
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of AD/eczema as defined by Williams's criteria with clinical signs of infected AD/eczema on trunk and/or extremities such as fluid drainage, blistered skin, white or yellow pus, severe itchiness and new burning sensation
* A minimum score of 1 for each of the signs in the m-EASI score in at least one of the pre-defined body areas (trunk and/or extremities)
* Subjects between 2 and 65 years of age
Exclusion Criteria:
* History of concurrent diseases that could interfere with trial assessments or pose a safety concern
* Subjects with other skin lesions, e.g. scarring, tattoos, or hyperpigmentation on the treatment area that could interfere with assessments
* Clinical findings such as severe heart, liver, kidney and lung deficiency, which will be impacted by the trial procedures at the investigator's discretion
* Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the last 4 weeks prior to randomisation at investigator's discretion
* Use of prohibited medication, i.e.
1. Systemic treatment with immunosuppressive or immunomodulating drugs(including Leigongteng) or corticosteroids within 28 days prior to randomisation
2. Use of topical or systemic antibiotics and anti-histamines within 14 days prior to randomisation
3. Phototherapy (e.g. PUVA, UVA or UVB therapy) within 28 days prior to randomisation
4. Topical treatment with immunomodulators (e.g. pimecrolimus, tacrolimus) within 14 days prior to randomisation
5. Topical treatment with corticosteroids or any other topical treatment within 7 days prior to randomisation
6. Use of any non-prescribed systemic or cutaneous medication within 7 days prior to randomisation
7. The use of analgesics at the discretion of the investigator is allowed before and during the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
65 Years
Study:
NCT03395132
Study Brief:
Protocol Section:
NCT03395132