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 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT05844618
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects 18 years of age or older at the time of consent.
2. Subject has clinically confirmed diagnosis of active AD, according to Hanifin and Rajka criteria.
3. Subject has at least a 6-month history of AD and had no significant flares in AD for at least 4 weeks before screening.
4. Subject has 2 applications areas (10 X 10 cm) with a lesional surface of at least 6 X 6 cm, preferably located on 2 distinct anatomical areas at Day 1.
Exclusion Criteria:
1. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
2. Subject has clinically infected AD.
3. Subject has a Fitzpatrick's Skin Phototype ≥5.
4. Subject has a history of skin disease or presence of skin condition, other than AD, that would interfere with the study assessments in the opinion of the investigator.
5. Subject is known to have immune deficiency or is immunocompromised.
6. Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1.
7. Subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
8. Subject has a known history of chronic infectious disease.
9. Subject has a known or suspected allergy to triamcinolone acetonide (Aristocort® C) or any component of the investigational product.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05844618
Study Brief:
Protocol Section:
NCT05844618