A Study to Determine Serum and Skin Biopsy Biomarkers in Patients Receiving Topical Corticosteroid (TCS) and Following TCS Withdrawal
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Intervention: Triamcinolone 0.1%
Intervention description: Topical ointment
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open label
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the differential expression of AD biomarkers in serum,
      plasma, and skin biopsies from both lesional and non-lesional skin in moderate to severe AD
      patients in the presence of TCS and after withdrawal from TCS.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients 18-75 years of age

          2. AD diagnosed by the Rajka/Hanifin criteria at the time of screening and that has been
             present for at least 1 year

          3. History of inadequate response to a stable regimen of TCS for 1 month (in the 3 months
             immediately preceding the screening visit) as treatment for their AD

          4. Eczema Area and Severity Index (EASI) score ≥ 14 at the screening and baseline visits

          5. Investigator's Global Assessment (IGA; 5-point) score ≥ 3 at the screening and
             baseline visits

          6. ≥10% body surface area involvement by AD

          7. A washout period prior to screening for those patients who have previously received
             the following medications:

               -  Cyclosporine/Oral Steroids/Imuran/Mycophenolate Mofetil/Other systemic
                  immunosuppressants: 4 weeks

               -  Phototherapy: 4 weeks

               -  Biologics: 5 half lives of the drug

        Exclusion Criteria:

          1. Evidence of other concomitant skin conditions (e.g., psoriasis or contact dermatitis)

          2. Use of topical calcineurin inhibitors within 4 weeks of screening

          3. Hypersensitivity to TCS or to any other ingredients contained by the emollient or TCS
             product used during the study

          4. Evidence of active skin infection at screening or baseline visit

          5. Evidence or history of active or latent infections such as tuberculosis or hepatitis C

          6. Patient clinical condition is not appropriate for treatment with protocol prescribed
             TCS

          7. Use of an investigational agent within 4 weeks prior to screening or within 5
             half-lives of the investigational agent, whichever is longer

          8. Use of a tanning booth/parlor within 4 weeks before the baseline visit

          9. Use of any anti-histamine medication within 4 weeks before the baseline visit.

         10. History of any condition (e.g. bleeding diathesis) that may predispose the patient to
             complications associated with the planned skin biopsy procedures

         11. Known current malignancy or current evaluation for a potential malignancy, including
             basal or squamous cell carcinoma of the skin or carcinoma in situ

         12. Other clinically significant medical disease that is uncontrolled despite treatment
             that is likely, in the opinion of the investigator, to impact the patient's ability to
             participate in the study or to impact the study pharmacodynamic (PD), or safety
             assessments

         13. Unwillingness or inability to comply with the study protocol for any other reason.