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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT00837551
Eligibility Criteria:
Inclusion Criteria:
* AD diagnosis (based on Hanifin's criteria) presenting a minimum of 1% and a maximum of 10% body surface area (BSA) excluding face, groin, scalp and genital areas.
* Disease severity index (EASI) of less than 12, Investigator's Global Assessment (IGA) of 2-3 at Day 0.
* In good general health and free of any condition that might impair evaluation of AD.
* Women of child bearing potential (WOCBP) had to have a negative a negative serum human-beta chorionic gonadotropin pregnancy test before randomization.
WOCBP had to abstain from sex or they and their partners had to use adequate contraceptive precautions for the duration of the study.
* Willing and able to comply with the protocol and attend all study visits.
* Provide a written informed consent form prior to initiation of study procedures.
Exclusion Criteria:
* Had spontaneously improving or rapidly deteriorating AD.
* Had AD lesions on only hands and/or feet.
* Had skin diseases other than AD.
* Had active allergic contact dermatitis or other non-atopic forms of dermatitis.
* Had other concomitant medical condition that could put the patient at risk during the study.
* Had a history of neurological/psychiatric disorders that could interfere with the patient's participation.
* Had systemic immunomodulatory therapies within 12 weeks prior to the baseline visit.
* Had prolonged exposure to natural or artificial ultraviolet radiation within 4 weeks of baseline visit.
* Had phototherapy (including laser), photo-chemotherapy or systemic AD therapy within 4 weeks prior to baseline visit.
* Had topical AD therapies in the areas to be treated within 2 weeks prior to the baseline visit.
* Had alcohol abuse in the last 2 years.
* Had allergic history to any non-medical ingredients of the study cream.
* Were treated with an investigational drug within 1 month of Day 0 or were currently participating in another trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00837551
Study Brief:
Protocol Section:
NCT00837551