A Proof of Concept Clinical Trial Evaluating the Safety and Efficacy of Eucrisa (Crisaborole) in Patients With Seborrheic Dermatitis
Condition: Seborrheic Dermatitis
MeSH terms: Dermatitis; Dermatitis, Seborrheic
Intervention: Crisaborole
Intervention description: Application of topical crisaborole 2% ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and its utility in the treatment of facial seborrheic dermatitis.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Seborrheic dermatitis is a common and recurrent dermatosis that characteristically involves
      the scalp, nasolabial folds, eyebrows, glabella, and upper eye lids. It presents as an
      erythematous, thin scaly patch with a greasy sandpaper texture that varies depending on
      disease severity. While seborrheic dermatitis most frequently occurs on the face, it can
      involve other areas of the body especially the chest, abdomen, and axilla. Overall incidence
      is thought to be between 2-5% of the general population, though this is likely an
      underestimation. Pruritus is variable, though the signs and symptoms of this disorder are
      certainly worsened by certain external conditions especially weather, personal perspiration,
      stress, and poor hygiene. Patients often complain about the red, scaly patches on the face.

      Antifungal agents are frequently used as monotherapy or in combination regimens in the
      treatment of seborrheic dermatitis. Topical corticosteroids are often used for their
      anti-inflammatory effects. Long term use of topical steroids on the face is not a preferred
      treatment modality due to the risk of striae development and other textural changes that
      occur over time. Therefore, topical crisaborole may be an alternative given its
      non-corticosteroid anti-inflammatory action. Crisaborole is a phosphodiesterase-4 (PDE-4)
      inhibitor that increases intracellular cyclic AMP (cAMP) levels to exert its
      anti-inflammatory effects. While it has not previously been investigated for its effects in
      seborrheic dermatitis, further studies evaluating its role in this disease are warranted.

      Therefore, the investigators propose a proof of concept study using topical crisaborole 2%
      ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and
      its utility in the treatment of facial seborrheic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Capable of understanding and willing to provide signed and dated written voluntary
             informed consent before any protocol specific procedures are performed.

          2. Male or female subjects 18 to 70 years of age.

          3. Able to complete the study and to comply with study instructions.

          4. Female subjects of childbearing potential must have a negative pregnancy test.
             Sexually active women of childbearing potential participating in the study must agree
             to use a medically acceptable form of contraception (which includes oral
             contraception, injectable or implantable methods, or intrauterine devices) during the
             entire duration of the study

          5. Mild to moderate seborrheic dermatitis on the face with an ISGA of 2 or 3 at baseline.

        Exclusion Criteria:

          1. Use of systemic antifungal agents, corticosteroids or other immunosuppressive
             therapies, or systemic retinoids within 4 weeks prior to the baseline visit.

          2. Use of topical antifungal therapy, corticosteroid therapy, or calcineurin inhibitors
             to the face, within 2 weeks prior to the baseline visit. Topical, over-the-counter
             antifungal shampoo will be allowed as long as it has remained constant for 4 weeks
             prior to baseline.

          3. Use of any investigational drugs within 4 weeks prior to the baseline visit, or
             subjects scheduled to receive an investigative drug other than the study product
             during the period of the study.

          4. History of known or suspected intolerance to any of the ingredients of the study
             product.

          5. Female subjects who are pregnant, trying to become pregnant or lactating.

          6. Any clinically relevant abnormal vital signs or findings on the physical examination
             which in the opinion of the investigator might interfere with the study assessments.

          7. A clinically relevant history of abuse of alcohol or other drugs.

          8. Any major illness within 30 days prior to the baseline visit.

          9. Subjects with any clinically significant condition which would, in the opinion of the
             investigator, compromise the subject's participation in the study.

         10. Subjects who are immunocompromised (ex: HIV).

         11. Considered unable or unlikely to attend the necessary visits.

         12. Currently using any medication, which in the opinion of the investigator may affect
             the evaluation of the study product

         13. Subjects who have significant neurological conditions (Parkinson's disease or Stroke),
             who in the opinion of the investigator are not eligible for the study due to the
             severity of neurological condition.

         14. Subjects with a history of non-melanoma skin cancer of the face within 6 months