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

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT03567980
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 32.3
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Seborrheic Dermatitis	Drug: Crisaborole	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Proof of Concept Clinical Trial Evaluating the Safety and Efficacy of Eucrisa (Crisaborole) in Patients With Seborrheic Dermatitis
• Actual Study Start Date: Sep 1, 2018
• Actual Primary Completion Date: Apr 30, 2020
• Actual Study Completion Date: May 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: topical crisaborole 2%	Drug: Crisaborole; 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.

Outcome Measures

Primary Outcome Measures

1. Percent Change in ISGA (Investigator's Static Global Assessment) Score [Baseline to 4 weeks]

   • Investigator's Static Global Assessment (ISGA) is a skin assessment tool utilized in clinical trials. The tool is based on a 5-point scale with 0 or 1 (clear or almost clear) being the best score one could receive, while a score of 4 is the worst score available and indicates severe disease. ISGA will be collected via skin examination to evaluate efficacy of Crisaborole 2% topical ointment in the treatment of seborrheic dermatitis. A 0 or 1 (clear or almost clear) on the ISGA would be considered a treatment success. Percent change in ISGA score from baseline to 4 weeks will be measured and reported.

Secondary Outcome Measures

1. Itch NRS (Itch Numeric Rating Scale) [Baseline to 4 weeks]

   • The Itch Numeric Rating Scale (NRS) is a subject-administered, 11 point horizontal scale anchored at 0 and 10, 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a subject itching is indicated by circling the number that best describes the worst level of itching in the past 24 hours. The Itch NRS (A numeric measurement of itch) will be collected to assess the percentage of improvement of patient reported itching. This will be calculated as a percent changes from baseline in the Itch NRS scale.

Other Outcome Measures

1. Number of Participants With Adverse Events That Are Related to Treatment. [Baseline to 4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermatology at the Whitaker Clinic	Birmingham	Alabama	United States	35249

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Boni Elewski, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 6, 2018

More Information

Publications

None provided.

• Responsible Party: Boni Elewski, Professor and Chair, UAB Department of Dermatology, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03567980
• Other Study ID Numbers: 180306
• First Posted: Jun 26, 2018
• Last Update Posted: Oct 29, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Dermatitis; Dermatitis, Seborrheic

Study Results

Participant Flow

Arm/Group Title	Topical Crisaborole 2%
Arm/Group Description	Crisaborole: 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.
Period Title: Overall Study
STARTED	30
COMPLETED	29
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Topical Crisaborole 2%
Arm/Group Description	Crisaborole: 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.
Overall Participants	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.6 (3.25)
Sex: Female, Male (Count of Participants)
Female	18 60%
Male	12 40%
Race/Ethnicity, Customized (Count of Participants)
Black or African American	16 53.3%
White	14 46.7%
Region of Enrollment (participants) [Number]
United States	30 100%

Outcome Measures

1. Primary Outcome

Title	Percent Change in ISGA (Investigator's Static Global Assessment) Score
Description	• Investigator's Static Global Assessment (ISGA) is a skin assessment tool utilized in clinical trials. The tool is based on a 5-point scale with 0 or 1 (clear or almost clear) being the best score one could receive, while a score of 4 is the worst score available and indicates severe disease. ISGA will be collected via skin examination to evaluate efficacy of Crisaborole 2% topical ointment in the treatment of seborrheic dermatitis. A 0 or 1 (clear or almost clear) on the ISGA would be considered a treatment success. Percent change in ISGA score from baseline to 4 weeks will be measured and reported.
Time Frame	Baseline to 4 weeks

Outcome Measure Data

Analysis Population Description

One participant withdrew due to adverse events (headaches and facial pain)

Arm/Group Title	Topical Crisaborole 2%
Arm/Group Description	Crisaborole: 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.
Measure Participants	29
Number [percent change]	67.8

2. Secondary Outcome

Title	Itch NRS (Itch Numeric Rating Scale)
Description	• The Itch Numeric Rating Scale (NRS) is a subject-administered, 11 point horizontal scale anchored at 0 and 10, 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a subject itching is indicated by circling the number that best describes the worst level of itching in the past 24 hours. The Itch NRS (A numeric measurement of itch) will be collected to assess the percentage of improvement of patient reported itching. This will be calculated as a percent changes from baseline in the Itch NRS scale.
Time Frame	Baseline to 4 weeks

Outcome Measure Data

Analysis Population Description

One participant withdrew due to adverse events (headaches and facial pain)

Arm/Group Title	Topical Crisaborole 2%
Arm/Group Description	Crisaborole: 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.
Measure Participants	29
Number [percent change]	45

3. Other Pre-specified Outcome

Title	Number of Participants With Adverse Events That Are Related to Treatment.
Time Frame	Baseline to 4 weeks

Outcome Measure Data

Analysis Population Description

All enrolled patients were analyzed.

Arm/Group Title	Topical Crisaborole 2%
Arm/Group Description	Crisaborole: 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.
Measure Participants	30
Count of Participants [Participants]	1 3.3%

Adverse Events

Time Frame	Adverse event data were collected from the screening visit to the end of study visit for each participant, a total of 4 weeks per participant evaluation.
Arm/Group Title	Topical Crisaborole 2%
Arm/Group Description	Crisaborole: 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.
All Cause Mortality
	Topical Crisaborole 2%
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Serious Adverse Events
	Topical Crisaborole 2%
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	Topical Crisaborole 2%
	Affected / at Risk (%)	# Events
Total	1/30 (3.3%)
General disorders
Headaches	1/30 (3.3%)	1
Facial Pain	1/30 (3.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.