Trial Outcomes & Findings for A Proof of Concept Clinical Trial Evaluating the Safety and Efficacy of Eucrisa (Crisaborole) in Patients With Seborrheic Dermatitis (NCT NCT03567980)

Results Overview

• 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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

Baseline to 4 weeks

Results posted on

2021-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Topical Crisaborole 2% 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 Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Topical Crisaborole 2% 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 Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topical Crisaborole 2% n=30 Participants 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.
Age, Continuous	52.6 years STANDARD_DEVIATION 3.25 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	16 Participants n=5 Participants
Race/Ethnicity, Customized White	14 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 4 weeks

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

• 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.

Outcome measures

Outcome measures
Measure	Topical Crisaborole 2% n=29 Participants 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.
Percent Change in ISGA (Investigator's Static Global Assessment) Score	67.8 percent change

SECONDARY outcome

Timeframe: Baseline to 4 weeks

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

• 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.

Outcome measures

Outcome measures
Measure	Topical Crisaborole 2% n=29 Participants 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.
Itch NRS (Itch Numeric Rating Scale)	45 percent change

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 4 weeks

Population: All enrolled patients were analyzed.

Outcome measures

Outcome measures
Measure	Topical Crisaborole 2% n=30 Participants 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.
Number of Participants With Adverse Events That Are Related to Treatment.	1 Participants

Adverse Events

Topical Crisaborole 2%

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Topical Crisaborole 2% n=30 participants at risk 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.
General disorders Headaches	3.3% 1/30 • Number of events 1 • 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.
General disorders Facial Pain	3.3% 1/30 • Number of events 1 • 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.

Additional Information

Dr. Boni Elewski

University of Alabama at Birmingham

Phone: 205-502-9960

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place