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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03356977




Registration number
NCT03356977
Ethics application status
Date submitted
31/10/2017
Date registered
29/11/2017
Date last updated
10/10/2019

Titles & IDs
Public title
A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis
Scientific title
A PHASE 4, MULTICENTER, OPEN-LABEL SAFETY STUDY OF CRISABOROLE OINTMENT 2% IN CHILDREN AGED 3 MONTHS TO LESS THAN 24 MONTHS WITH MILD TO MODERATE ATOPIC DERMATITIS
Secondary ID [1] 0 0
CARE 1
Secondary ID [2] 0 0
C3291002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Crisaborole ointment 2%

Experimental: Crisaborole ointment 2% - Subjects will be dosed for 28 days. A thin layer of ointment will be applied to all areas designated for treatment.


Treatment: Drugs: Crisaborole ointment 2%
Applied BID
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions
Timepoint [1] 0 0
Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)
Primary outcome [2] 0 0
Number of Participants With Clinically Significant Height Values Meeting Pre-defined Criteria
Timepoint [2] 0 0
Baseline (Day 1) up to Day 29 (end of treatment)
Primary outcome [3] 0 0
Number of Participants With Clinically Significant Weight Values Meeting Pre-defined Criteria
Timepoint [3] 0 0
Baseline (Day 1) up to Day 29 (end of treatment)
Primary outcome [4] 0 0
Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria
Timepoint [4] 0 0
Baseline (Day 1) up to Day 29 (end of treatment)
Primary outcome [5] 0 0
Number of Participants With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria
Timepoint [5] 0 0
Baseline (Day 1) up to Day 29 (end of treatment)
Primary outcome [6] 0 0
Number of Participants With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria
Timepoint [6] 0 0
Baseline (Day 1) up to Day 29 (end of treatment)
Primary outcome [7] 0 0
Number of Participants With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria
Timepoint [7] 0 0
Baseline (Day 1) up to Day 29 (end of treatment)
Primary outcome [8] 0 0
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria
Timepoint [8] 0 0
Baseline (Day 1) up to Day 29 (end of treatment)
Primary outcome [9] 0 0
Number of Participants With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria
Timepoint [9] 0 0
Baseline (Day 1) up to Day 29 (end of treatment)

Eligibility
Key inclusion criteria
Aged = 3 months at the screening visit to < 24 months on baseline/Day 1, diagnosed with AD
Minimum age
3 Months
Maximum age
23 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with any clinically significant dermatological condition or disease (including active or potentially recurrent non-AD dermatological conditions that overlap with AD such as Netherton Syndrome)

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/04/2019
Sample size
Target
Accrual to date
Final
137
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Australian Clinical Research Network Pty Ltd - Maroubra
Recruitment hospital [2] 0 0
The Skin Centre - Benowa
Recruitment hospital [3] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [4] 0 0
Eastern Health - Box Hill
Recruitment hospital [5] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [6] 0 0
The Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
United States of America
State/province [14] 0 0
Vermont
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.
Trial website
https://clinicaltrials.gov/study/NCT03356977
Trial related presentations / publications
Schlessinger J, Shepard JS, Gower R, Su JC, Lynde C, Cha A, Ports WC, Purohit V, Takiya L, Werth JL, Zang C, Vlahos B; CARE 1 Investigators. Safety, Effectiveness, and Pharmacokinetics of Crisaborole in Infants Aged 3 to < 24 Months with Mild-to-Moderate Atopic Dermatitis: A Phase IV Open-Label Study (CrisADe CARE 1). Am J Clin Dermatol. 2020 Apr;21(2):275-284. doi: 10.1007/s40257-020-00510-6.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03356977