A Proof of Concept Clinical Trial Evaluating the Safety and Efficacy of Eucrisa (Crisaborole) in Patients With Seborrheic Dermatitis

Last updated: October 1, 2021
Sponsor: University of Alabama at Birmingham
Overall Status: Completed

Phase

4

Condition

Seborrhea

Seborrheic Dermatitis

Rosacea

Treatment

N/A

Clinical Study ID

NCT03567980
180306
  • Ages 18-70
  • All Genders

Study 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

Inclusion Criteria:

  1. Capable of understanding and willing to provide signed and dated written voluntaryinformed 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 agreeto use a medically acceptable form of contraception (which includes oralcontraception, injectable or implantable methods, or intrauterine devices) during theentire duration of the study
  5. Mild to moderate seborrheic dermatitis on the face with an ISGA of 2 or 3 at baseline.

Exclusion

Exclusion Criteria:

  1. Use of systemic antifungal agents, corticosteroids or other immunosuppressivetherapies, or systemic retinoids within 4 weeks prior to the baseline visit.
  2. Use of topical antifungal therapy, corticosteroid therapy, or calcineurin inhibitorsto the face, within 2 weeks prior to the baseline visit. Topical, over-the-counterantifungal shampoo will be allowed as long as it has remained constant for 4 weeksprior to baseline.
  3. Use of any investigational drugs within 4 weeks prior to the baseline visit, orsubjects scheduled to receive an investigative drug other than the study productduring the period of the study.
  4. History of known or suspected intolerance to any of the ingredients of the studyproduct.
  5. Female subjects who are pregnant, trying to become pregnant or lactating.
  6. Any clinically relevant abnormal vital signs or findings on the physical examinationwhich 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 theinvestigator, 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 affectthe 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 theseverity of neurological condition.
  14. Subjects with a history of non-melanoma skin cancer of the face within 6 months

Study Design

Total Participants: 30
Study Start date:
September 01, 2018
Estimated Completion Date:
May 12, 2021

Connect with a study center

  • Dermatology at the Whitaker Clinic

    Birmingham, Alabama 35249
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.