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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT01469767
Eligibility Criteria:
Inclusion Criteria:
* Male or female with mild to severe atopic dermatitis, 12 years of age or older, that agree to participate and provide written consent (parent permission and assent if applicable).
* Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating of 2 through 4 in the Investigator Global Assessment).
* Visual Analog Scale of Itch score at Baseline must be greater than or equal to 50 on a 100-point scale.
* Percentage of overall body surface area of involvement (BSA) must be ≥2%.
* Women of childbearing potential will be allowed to participate in the study, and will be required to use at least one form of birth control.
Exclusion Criteria:
* Use within four weeks from Baseline any systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids.
* Application or use within two weeks of Baseline topical corticosteroid medications or topical anti-inflammatory medication, which may influence study outcome.
* Presence of a concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
* Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study.
* Use of anti-histamines while participating in the study will not be permitted unless the subject meets criteria for anti-histamine use on the VAS scale. Additionally, the subject must remain on a stable dose of anti-histamine throughout the study period. If a patient meets such criteria for anti-histamine use, this will be noted in the subject's chart.
* Amount of disease involvement that would require \>60 gm of cream in a 1 week period.
* Subjects with known allergy or sensitivity to topical Vanos® cream or components.
* Pregnant women
* Women who are breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT01469767
Study Brief:
Protocol Section:
NCT01469767