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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT00125333
Eligibility Criteria:
Inclusion Criteria:
* Are 18 through 65 years of age and sign an informed consent
* Have been given a diagnosis of mild to moderate atopic dermatitis as defined by: \*Pruritus; \*Eczematous dermatitis (acute, subacute, chronic) involving at least current or prior flexural lesions with chronic or relapsing course; \*Early age of onset (prior to 10 years of age, by history); \*Personal or family history of atopy
* If receiving antihistamines, are on a stabilized dose, and expect to maintain this dose throughout the study
* Are females or males of reproductive potential who are compliant in using adequate birth control or are females or males not of reproductive potential
Exclusion Criteria:
* Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
* Have immunocompromised status (such as known human immunodeficiency virus infection)
* Have any clinically significant abnormal clinical laboratory test results at Screening
* Have a history of malignancy not in remission for at least 5 years excluding basal cell carcinoma and nonperiorificial squamous cell carcinoma of the skin
* Have an active intercurrent infection
* Have applied any topical medication (including corticosteroid, calcineurin inhibitor, topical H1 and H2 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment within 1 week of the Day 1 visit; have used any systemic antibiotic within 1 week prior to the Day 1 visit; have used any systemic treatment for atopic dermatitis (including systemic corticosteroids, nonsteroidal immunosuppressants, or treatment with light) within 4 weeks prior to the Day 1 visit; have used an investigational drug for any reason within 4 weeks of the Day 1 visit; have used intranasal and/or inhaled corticosteroids at doses \> 2 mg prednisone or equivalent per day within 4 weeks of the Day 1 visit; or have used immunosuppressive or immunomodulating drugs such as etanercept, alefacept, or infliximab within 16 weeks prior to Day 1
* Have a history of hypersensitivity or allergic reactions to parabens or any other ingredient in the vehicle formulation
* If female, are pregnant or lactating, or intend to become pregnant during the study period
* If male, have a female partner who is pregnant or lactating, or intends to become pregnant during the study period
* Have any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate in or complete the trial, or which places the subject at undue risk
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00125333
Study Brief:
Protocol Section:
NCT00125333