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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT01177566
Eligibility Criteria:
Inclusion Criteria:
* Males and females ≥ 2 years old.
* Subjects must be in good general health as confirmed by medical history and physical examination.
* Females of child-bearing potential must have a negative urine pregnancy test at the baseline visit and agree to use adequate birth control during the study (barrier, oral, injection, intrauterine). NOTE: Post-menopausal (amenorrheic for at least one year) and surgically sterile (tubal ligation and/or hysterectomy) are considered to be of non child-bearing potential.
* Clear diagnosis of atopic dermatitis for at least one year.
* Subject must have a static Physician's Global Assessment (PGA) of at least 2 (mild severity) for each selected target lesion
* Disease must be stable or slowly worsening for more than one week prior to entering the study.
* Subjects must be able to read, sign, and date the informed consent, and abide by study restrictions for its duration.
Exclusion Criteria:
* Females who are pregnant, attempting to conceive, or breastfeeding.
* Subjects with known hypersensitivity to study drug.
* Subjects with overt signs of skin atrophy, telangiectasias and/or striae in the target area.
* Subjects with a current active skin malignancy or infection.
* Subjects requiring the use of medications known to alter the course of atopic dermatitis during the study treatment.
* Subjects who have received systemic antibiotics within 2 weeks.
* Subjects using systemic corticosteroids or immunosuppressants within 28 days of entering the study.
* Subjects who have received topical corticosteroids or other topical therapies (tar, calcineurin inhibitors) for atopic dermatitis within 7 days of entering the study.
* Subjects using phototherapy (UVB, PUVA) within 28 days of entering the study.
* Subjects who are currently participating in or, with in the previous 28 days, have participated in another study for the treatment of atopic dermatitis.
* Subjects with clinical conditions that may post a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT01177566
Study Brief:
Protocol Section:
NCT01177566