Back to resultsDifferent Application Rates of Crisaborole Ointment 2% in Adults With Mild to Moderate Atopic Dermatitis
Primary Purpose
Dermatitis, Atopic
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Crisaborole 2%
Placebo ointment
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Atopic
Eligibility Criteria
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.
Sites / Locations
- Innovaderm Research Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Crisaborole 2% (application rate A, B, C)
Placebo ointment (vehicle)
Arm Description
Crisaborole (Marketed drug)
Placebo
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Target Area Assessment (TAA)
Change from baseline in TAA at Day 8 and Day 15
Full Information
NCT ID
NCT03868098
First Posted
March 7, 2019
Last Updated
August 23, 2021
Sponsor
Innovaderm Research Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03868098
Brief Title
Different Application Rates of Crisaborole Ointment 2% in Adults With Mild to Moderate Atopic Dermatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 21, 2019 (Actual)
Primary Completion Date
November 25, 2020 (Actual)
Study Completion Date
November 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovaderm Research Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Intra-individual
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Crisaborole 2% (application rate A, B, C)
Arm Type
Active Comparator
Arm Description
Crisaborole (Marketed drug)
Arm Title
Placebo ointment (vehicle)
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Crisaborole 2%
Other Intervention Name(s)
Eucrisa
Intervention Description
Crisaborole ointment 2% (application rate A, B, C) for 15 days (double blind)
Intervention Type
Drug
Intervention Name(s)
Placebo ointment
Intervention Description
Placebo ointment (vehicle)
Primary Outcome Measure Information:
Title
Total Signs Score (TSS)
Description
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).
Time Frame
Baseline, Day 15
Secondary Outcome Measure Information:
Title
Total Signs Score (TSS)
Description
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).
Time Frame
Baseline, Day 8, Day 15
Title
Target Area Assessment (TAA)
Description
Change from baseline in TAA at Day 8 and Day 15
Time Frame
Change from baseline in TAA at Day 8 and Day 15.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bissonnette, MD
Organizational Affiliation
Medical Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Innovaderm Research Inc.
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Different Application Rates of Crisaborole Ointment 2% in Adults With Mild to Moderate Atopic Dermatitis
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