Different Application Rates of Crisaborole Ointment 2% in Adults With Mild to Moderate Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

Official title:

A Randomized, Double-Blind, Intra-Individual, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Different Application Rates of Topically Applied Crisaborole Ointment 2% in Adult Subjects With Mild to Moderate Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03868098
• Other study ID #: Inno-6049
• Status: Completed
• Phase: Phase 4
• Start date: May 21, 2019
• Est. completion date: November 25, 2020

Study information

• Verified date: August 2021
• Source: Innovaderm Research Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to evaluate the efficacy and safety of 3 different application rates of topically applied Crisaborole ointment 2% over vehicle in adults with mild to moderate atopic dermatitis (AD). In each subject four application areas will be identified. Each subject will receive 4 treatments: the 3 different application rates of the active treatment and the vehicle. The areas will be randomly assigned to treatment with topical Crisaborole ointment 2% and vehicle, once daily, for 2 weeks, without occlusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 25, 2020
• Est. primary completion date: November 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of active atopic dermatitis (AD) with at least 6 month history prior to screening and that has been clinically stable for 1 month.

• Has four application areas of 3 cm in diameter with a TSS of =5 and TAA of moderate at Day 1. The application areas must not be located on the face, scalp, axillae, groin, genitals, hands, and feet. The application areas should be =1 cm apart.

Exclusion Criteria:

• Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.

• Subject has clinically infected AD.

• Subject has a Fitzpatrick's Skin Phototype =5.

• Subject is known to have immune deficiency or is immunocompromised.

• Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or successfully treated localized carcinoma in situ of the cervix are not to be excluded.

• Subject had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.

• Subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.

• Subject has a known history of chronic infectious disease (eg, hepatitis B, hepatitis C, or infection with human immunodeficiency virus).

• Subject with a known lack of efficacy to crisaborole.

• Subject has a known or suspected allergy to crisaborole, including any non-medicinal ingredient, or component of the container.

• Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Drug:
• Crisaborole 2%
Crisaborole ointment 2% (application rate A, B, C) for 15 days (double blind)
• Placebo ointment
Placebo ointment (vehicle)

Locations

Country	Name	City	State
Canada	Innovaderm Research Inc.	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Innovaderm Research Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Signs Score (TSS)	Change from baseline in TSS in target lesions treated with crisaborole ointment 2% or vehicle at Day 15.; Total Signs Score (TSS) of the lesion is the assessment of the severity of erythema, edema/papulation, excoriation, and lichenification. Each of these subscales is scored independently using the 4-point severity scale with a value range from 0 to 3; 0 is the minimum (best) and 3 is the maximum (worst). The total score is computed by the sum of each subscale where the total ranges from the minimum 0 (best) to the maximum 12 (worst).	Baseline, Day 15
Secondary	Total Signs Score (TSS)	Change from baseline in lesion severity as measured by TSS at Day 8 and Day 15; Total Signs Score (TSS) of the lesion is the assessment of the severity of erythema, edema/papulation, excoriation, and lichenification. Each of these subscales is scored independently using the 4-point severity scale with a value range from 0 to 3; 0 is the minimum (best) and 3 is the maximum (worst). The total score is computed by the sum of each subscale where the total ranges from the minimum 0 (best) to the maximum 12 (worst).	Baseline, Day 8, Day 15
Secondary	Target Area Assessment (TAA)	Change from baseline in TAA at Day 8 and Day 15	Change from baseline in TAA at Day 8 and Day 15.