Atopic Dermatitis
Conditions
Interventions
Product Name: Crisaborole
Product Code: PF-06930164
Pharmaceutical Form: Ointment
INN or Proposed INN: Crisaborole
CAS Number: 906672-24-3
Concentration unit: % percent
Concentration type: equal
Conce
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Is male or female 2 years and older at the Screening visit/time of informed consent/assent diagnosed with mild-moderate AD (according to the criteria of Hanifin and Rajka), of at least 5% BSA and ISGA=2 at baseline(Day1) Are the trial subjects under 18? yes Number of subjects for this age range: 232 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 154 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Has any clinically significant medical disorder, condition, or disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome) or clinically significant physical examination finding at Screening that in the PI’s or designee’s opinion may interfere with study objectives. -Has unstable AD or any consistent requirement for high/strong potency or very high/very strong potency topical corticosteroids to manage AD signs and symptoms. - Has participated in a previous crisaborole clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the efficacy of crisaborole ointment, 2% applied BID versus Vehicle in Chinese and Japanese pediatric and adult subjects (ages 2 years and older) with mild to moderate Atopic Dermatitis (AD); - To evaluate the safety and tolerability of crisaborole ointment, 2% applied twice daily (BID) versus Vehicle in Chinese and Japanese pediatric and adult subjects (ages 2 years and older) with mild to moderate AD.;Secondary Objective: - To evaluate the effect of crisaborole ointment, 2% applied BID versus Vehicle on additional efficacy endpoints in Chinese and Japanese pediatric and adult subjects (ages 2 years and older) with mild to moderate AD; - To evaluate the effect of crisaborole ointment, 2% applied BID versus Vehicle on patient/observer reported outcomes over time in Chinese and Japanese pediatric and adult subjects (ages 2 years and older) with mild and moderate AD. ;Primary end point(s): - Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Daxiii; - Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs); - Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters; - Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs.;Timepoint(s) of evaluation of this end point: - Baseline, Day 29 - Baseline up to Day 60 - Baseline up to Day 29 - Baseline up to Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of Participants Achieving Improvement in Investigator’s Static Global Assessment (ISGA) at Day 29; - Percentage of Participants Achieving Success in ISGA at Day 29; - Change From Baseline in Peak Pruritus Numeric Rating Scale (NRS) at Week 4-for Participants =12 years; - Percentage of Participants Achieving Success in ISGA Over Time; - Percentage of Participants Achieving Improvement in ISGA Over Time; - Percent Change From Baseline in EASI Total Score Over Time; - Change from Baseline in Percent Body Surface Area (%BSA) Over Time; - Percentage of Participants Achieving EASI-50 Over Time; - Percentage of Participants Achieving EASI-75 Over Time; - Change From Baseline in Peak Pruritus NRS Over Time-for Participants = 12 Years; - Change from Baseline in Patient Reported Itch Severity Scale Over Time-for Participants =6 Years and <12 Years; - Change from Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years; - Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time; - Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score Over Time; - Change From Infants’ Dermatitis Quality of Life Index (IDQOL) Total Score Over Time; - Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score Over Time; - Change From Baseline in Patient-Oriented Eczema Measure (POEM) Over Time in Participants =12 years; - Change From Baseline in POEM Over Time in Participants =2 Years and <12 Years; - Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score; - Patient Global Impression of Change (PGIC) Score; - Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score; - Observer Reported Global Impression of Change (OGIC) Score.;Timepoint(s) of evaluation of this end point: - Baseline, Day 29 - Baseline, Day 29 - Baseline, Week 4 - Baseline, Da | — |
Countries
China, Japan
Contacts
Public ContactClinicalTrials.gov Call Center
Pfizer Inc.
Outcome results
None listed