Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 3 (TRuE-AD3)

Are you eligible to participate in this study?

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

  • Conditions:
    Atopic Dermatitis (ad)
  • Age: Between 2 - 11 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Diagnosis of Atopic Dermatitis (AD)
    2. AD duration of at least 3 months
    3. Eczema patches on the skin (if hands/feet or genitalia only they do not qualify)
    4. For children aged 6 years to < 12 years, baseline itch Numerical Rating Scale (NRS) score = 4
    5. Participants/guardians who agree to discontinue all agents used by the participant to treat AD from the screening visit through the final safety follow-up visit
    6. For sexually active participants, willingness to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation with the exception of male and female participants who are prepubescent
    7. Ability to comprehend and willingness to sign an ICF or written informed consent of the parent(s) or legal guardian and a verbal or written assent from the participant when possible

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

    1. An unstable course of Atopic Dermatitis (spontaneously improving or rapidly deteriorating)
    2. Concurrent conditions and history of other diseases
      • Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome) or a history of malignant disease within 5 years before the baseline visit
      • Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before study visit
      • Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox, clinically infected AD, impetigo) within 1 week before the study visit
      • Any other skin disorder (eg, generalized erythroderma such as Netherton syndrome), pigmentation, or extensive scarring
      • Presence of AD lesions only on the hands or feet without prior history of lesions present in other classic areas of involvement such as the face or the flexural fold
      • Other types of eczema
      • Chronic asthma requiring more than 880 µg/day of inhaled budesonide or equivalent high dose of other inhaled corticosteroids
      • Any participant on maintenance dialysis
      • A medical history of hepatitis B virus or hepatitis C virus infection
    3. Any serious illness or medical, physical, or psychiatric condition(s) that would interfere with full participation in the study
    4. Previous treatment with systemic or topical JAK inhibitors
    5. Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation
    6. Current treatment or treatment within 30 days with another investigational medication or current enrollment in another investigational drug study



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