Evaluating Treatment Resistant Dermatitis TaroIIR

Psoriasis and atopic dermatitis are chronic inflammatory disease that account for a
significant amount of patients in most dermatological practices. Topical corticosteroid
agents are often prescribed for treatment of both these conditions, especially when they are
localized rather than wide spread. Prolonged treatment with corticosteroids occasionally
results in resistance to treatment. The development of resistance to treatment is termed
tachyphylaxis. Tachyphylaxis has been thought to be a result of down regulation of target
receptors, resulting is a decreased metabolic effect of the compound.

Poor adherence, rather than down regulation of receptors, may be the primary cause of
tachyphylaxis to topical corticosteroids. Patients' use of topical medications decrease over
time. Topical spray vehicles have become increasingly more popular because of their rapid
application and ease of use. Desoximetasone 0.25% spray is a well-tolerated, FDA approved,
potent topical corticosteroid that rapidly and successfully treats inflammatory skin
diseases.

Lots of treatment options exist for psoriasis; however, some patients do not get better using
these medications. These patients are said to have resistant disease. In this study, we
define resistant disease by failure of previous topical steroid treatment. Poor adherence is
a barrier to positive clinical outcomes. Failure to respond to medication may be a result of
poor adherence rather than resistance to the topical therapy. The purpose of this study is to
delineate between the two.

The primary objective of the study is to determine, under conditions designed to assure good
adherence, whether topical 0.25% desoximetasone spray improves clinical outcomes in patients
who have resistant inflammatory skin disease defined by failure of previous topical steroid
treatment.

We propose to enroll 12 subjects with psoriasis and 12 subjects with atopic dermatitis who
have "failed" previous topical treatment. Subjects will be required to have body surface area
involvement that can be reasonably treated with topical treatment. At the baseline visit,
patients will be given Topicort spray and will be shown how to use it. Patients will apply
the medication at the initial visit under supervision. Subjects with atopic dermatitis will
be treated for 1 week; subjects with psoriasis will be treated for 2 weeks. Visits will take
place at baseline, 3 days, 1 week, and in the case of psoriasis, 2 weeks. All subjects
enrolled in the study will receive nominal compensation per visit.

To assure good adherence to treatment, patients will be called twice each day, morning and
evening, at predetermined times to go over their use of the medication. Disease severity will
be measured by EASI (atopic dermatitis)/PASI (psoriasis), Investigator Global Assessment
(IGA), and Pruritus Visual Analog Scale (Pruritus VAS). Based on our previous experience, we
expect rapid improvement in disease severity measures with good adherence to short term use
of highly effective topical treatment. Mean and median changes in the efficacy measures will
be reported. In the primary analyses, Wilcoxon signed rank tests will be used to analyze
improvements in assessments at end of study compared to baseline.

Inclusion Criteria:

Male or female ≥18 years of age at baseline visit.

Documentation of plaque-type psoriasis or atopic dermatitis diagnosis as evidenced by one
or more clinical features

Written informed consent (and assent when applicable) obtained from subject or subject's
legal representative and ability for subject to comply with the requirements of the study

Exclusion Criteria:

Pregnant, breastfeeding, or unwilling to practice birth control during participation in the
study.

Presence of a condition or abnormality that in the opinion of the Investigator would
compromise the safety of the patient or the quality of the data.

No access to a phone throughout the day

Subject is diagnosed with a disease that is known to effect adherence and would otherwise
bias our results (Such as Alzheimer's or dementia)

Patient had a history of allergy or sensitivity to corticosteroids or history of any drug
hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise
the safety of the patient or the results of the study.