UTMB

Inclusion Criteria:

All answers must be Yes for subject to be eligible

Yes

No

Subjects must be male or female, at least 3 months of age, and not greater than 12 months of age on the date of Baseline Visit.

Subjects with atopic dermatitis covering >35% Body Surface Area (BSA) excluding the eyelids, perioral area, around the nostrils, and in the diaper area of those subjects who wear diapers or plastic pants.

Subjects must have atopic dermatitis with a total severity score of at least 6.0 for any three of eight potential signs and symptoms (as listed in Section 5.1.8), where each sign/ symptom is rated on a scale of 0 (absent) to 3 (severe).

Subject’s parent or legal guardian must have signed a current IRB approved written informed consent.

Subject’s consenting parent/ guardian must be willing and able to understand and comply with the requirements of the study, apply the study medication as instructed, return for the required visits, comply with therapy prohibitions, and be able to complete the study.

Subjects must be in good health, as confirmed by medical history and physical exam, and free from any clinically significant disease/ condition, other than atopic dermatitis, that might interfere with the study evaluations.

Exclusion Criteria:

All answers must be No for subject to be eligible

Yes

No

Subjects who have signs of skin atrophy in the areas to be treated with study drug.

Subjects who have acute self-limiting atopic dermatitis, e.g., allergic contact eczema, etc., which is likely to improve spontaneously during the study.

Subjects who have a known or suspected history of any condition that may be exacerbated by treatment with CutivateÒ (Fluticasone Propionate) Lotion 0.05% or that would impair the examination of the treatment area (i.e., psoriasis).

Subjects who have any disease affecting the HPA-axis (e.g. Addison’s Disease, Cushing’s Syndrome).

Subjects with known or suspected history of a clinically significant systemic disease (e.g. immunological deficiencies), unstable medical disorders (e.g. unstable diabetes), life-threatening disease, or current malignancies.

Subjects who have a known or suspected hypersensitivity to any of the following (in any dosage form): lidocaine/prilocaine, heparin, fluticasone propionate, any component of the study medications, or to any of the components of the cosyntropin.

Subjects who have been treated with any of the following chronic therapies (more than 4 weeks continuously) - cyclosporine, methotrexate and PUVA for skin lesions within 4 weeks prior to the start of study drug (Day 1) or have an anticipated need for any such systemic therapy during the study.

Subjects who require treatment with systemic retinoids (e.g. TegisonÒ, AccutaneÒ, AcitretinÒ) or topical retinoids (e.g. TazoracÒ) during the course of the study.

Subjects who have received any topical corticosteroid therapies within 1 week prior to the start of study drug or anticipated need for use during the study. (Bland emollients may be used during the screening phase and post-treatment phase, if applicable, and on untreated areas during the treatment phase.)

Subjects who have received inhaled or intranasal corticosteroid therapies within 1 week prior to the start of study drug (Day 1) or anticipated need for use during the study.

Subjects who have received systemic corticosteroids within one month prior to the start of the study drug (Day 1).

Subjects who may require treatment with any other topical or systemic therapy for the study disease other than bland emollients in untreated areas of disease, with the exception of those approved by the sponsor and known to have no effect on cortisol levels and HPA axis function.

Subjects who require use of tanning booths, sunbathing, or ultraviolet light treatment during the course of the study.

Subjects who require the use of any medication known to affect cortisol levels of HPA axis integrity.

Subjects who have any condition that would compromise compliance, in the investigator’s opinion, with this protocol.

Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study entry.

Subjects who have been previously enrolled in this study.