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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT00838708
Eligibility Criteria:
Inclusion Criteria:
* Males and females aged 18 years and over moderate to severe AD pruritus
* Written signed and dated informed consent
* Satisfactory medical assessment with no clinically relevant abnormalities
Exclusion Criteria:
* Subject with active and pruritic AD covering a body surface area (BSA) \> 20%
* Subject with severe AD defined as an IGA score of 4
* Subject with current or recurrent skin disease (except AD) that could affect the site of application of action, absorption or disposition of the investigational product, or clinical, laboratory assessments.
* Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
* Subject with known or suspected intolerance or hypersensitivity to the Investigational products or any of the stated ingredients.
* Subject who has a medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with interpretation of trial results and, in the judgment if the investigator, would make the subject inappropriate for entry into this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00838708
Study Brief:
Protocol Section:
NCT00838708