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

Primary Purpose

Seborrheic Dermatitis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Crisaborole

About this trial

This is an interventional treatment trial for Seborrheic Dermatitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
Male or female subjects 18 to 70 years of age.
Able to complete the study and to comply with study instructions.
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
Mild to moderate seborrheic dermatitis on the face with an ISGA of 2 or 3 at baseline.

Exclusion Criteria:

Use of systemic antifungal agents, corticosteroids or other immunosuppressive therapies, or systemic retinoids within 4 weeks prior to the baseline visit.
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.
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.
History of known or suspected intolerance to any of the ingredients of the study product.
Female subjects who are pregnant, trying to become pregnant or lactating.
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.
A clinically relevant history of abuse of alcohol or other drugs.
Any major illness within 30 days prior to the baseline visit.
Subjects with any clinically significant condition which would, in the opinion of the investigator, compromise the subject's participation in the study.
Subjects who are immunocompromised (ex: HIV).
Considered unable or unlikely to attend the necessary visits.
Currently using any medication, which in the opinion of the investigator may affect the evaluation of the study product
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.
Subjects with a history of non-melanoma skin cancer of the face within 6 months

Sites / Locations

Dermatology at the Whitaker Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

topical crisaborole 2%

Arm Description

Outcomes

Primary Outcome Measures

Percent Change in ISGA (Investigator's Static Global Assessment) Score

• 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

Itch NRS (Itch Numeric Rating Scale)

• 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.

Full Information

NCT ID

NCT03567980

First Posted

June 11, 2018

Last Updated

October 1, 2021

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT03567980

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

September 1, 2018 (Actual)

Primary Completion Date

April 30, 2020 (Actual)

Study Completion Date

May 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seborrheic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

topical crisaborole 2%

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

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.

Primary Outcome Measure Information:

Title

Percent Change in ISGA (Investigator's Static Global Assessment) Score

Description

Time Frame

Baseline to 4 weeks

Secondary Outcome Measure Information:

Title

Itch NRS (Itch Numeric Rating Scale)

Description

Time Frame

Baseline to 4 weeks

Other Pre-specified Outcome Measures:

Title

Number of Participants With Adverse Events That Are Related to Treatment.

Time Frame

Baseline to 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed. Male or female subjects 18 to 70 years of age. Able to complete the study and to comply with study instructions. 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 Mild to moderate seborrheic dermatitis on the face with an ISGA of 2 or 3 at baseline. Exclusion Criteria: Use of systemic antifungal agents, corticosteroids or other immunosuppressive therapies, or systemic retinoids within 4 weeks prior to the baseline visit. 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. 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. History of known or suspected intolerance to any of the ingredients of the study product. Female subjects who are pregnant, trying to become pregnant or lactating. 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. A clinically relevant history of abuse of alcohol or other drugs. Any major illness within 30 days prior to the baseline visit. Subjects with any clinically significant condition which would, in the opinion of the investigator, compromise the subject's participation in the study. Subjects who are immunocompromised (ex: HIV). Considered unable or unlikely to attend the necessary visits. Currently using any medication, which in the opinion of the investigator may affect the evaluation of the study product 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. Subjects with a history of non-melanoma skin cancer of the face within 6 months

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boni Elewski, MD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dermatology at the Whitaker Clinic

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35249

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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