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:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT01993420
Eligibility Criteria:
Inclusion Criteria:
* Male or female 18 to 70 years of age.
* Clinical diagnosis of stable atopic dermatitis (AD) and with two lesions of similar size and have an identical score of at least 5 but no more than 9 on the sum of the individual components of the Eczema Area and Severity Index (EASI) at the Target Lesion scale.
* Male or non-pregnant, non-lactating females.
* Signed informed consent.
Exclusion Criteria:
* Subjects who have unstable atopic dermatitis (AD).
* Significant infection at the target lesion site.
* Prior or concomitant use of systemic therapies for AD within the past 4 weeks. - Prior or concomitant use of topical treatments for AD, to within 10 cm of the target lesion within the past 4 weeks.
* Prior or concomitant use of oral retinoids for AD within the last 6 months.
* Use of biologics for AD within the past 3 months, or 5 half-lives (whichever is longer).
* Subjects who have poor skin condition within 5 cm of the target lesion.
* Subjects who are current drug or alcohol abusers; have a history of immunodeficiency disease; or are a poor medical risk because of other systemic diseases or active uncontrolled infections.
* Subjects with an unstable medical condition or a medical condition not adequately controlled with standard medical therapy.
* Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days.
* Subjects who have a clinically significant laboratory value at screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01993420
Study Brief:
Protocol Section:
NCT01993420