Last updated on January 2019

A Study to Determine Serum and Skin Biopsy Biomarkers in Patients Receiving Topical Corticosteroid (TCS) and Following TCS Withdrawal


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Dermatitis | Atopic
  • Age: Between 18 - 75 Years
  • Gender: Male or Female
  • Other:
    Male or female patients 18-75 years of age
    AD diagnosed by the Rajka/Hanifin criteria at the time of screening and that has been
    present for at least 1 year
    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
    Eczema Area and Severity Index (EASI) score ≥ 14 at the screening and baseline visits
    Investigator's Global Assessment (IGA; 5-point) score ≥ 3 at the screening and
    baseline visits
    ≥10% body surface area involvement by AD
    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

You may not be eligible for this study if the following are true:

  • Evidence of other concomitant skin conditions (e.g., psoriasis or contact dermatitis)
    Use of topical calcineurin inhibitors within 4 weeks of screening
    Hypersensitivity to TCS or to any other ingredients contained by the emollient or TCS
    product used during the study
    Evidence of active skin infection at screening or baseline visit
    Evidence or history of active or latent infections such as tuberculosis or hepatitis
    C
    Patient clinical condition is not appropriate for treatment with protocol prescribed
    TCS
    Use of an investigational agent within 4 weeks prior to screening or within 5
    half-lives of the investigational agent, whichever is longer
    Use of a tanning booth/parlor within 4 weeks before the baseline visit
    Use of any anti-histamine medication within 4 weeks before the baseline visit.
    History of any condition (e.g. bleeding diathesis) that may predispose the patient to
    complications associated with the planned skin biopsy procedures
    Known current malignancy or current evaluation for a potential malignancy, including
    basal or squamous cell carcinoma of the skin or carcinoma in situ
    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
    Unwillingness or inability to comply with the study protocol for any other reason.

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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