Crisaborole for Asian Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis

NCT04360187

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atopic Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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 participated in a previous crisaborole clinical study.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Crisaborole for Asian Subjects (?2 Years of Age) With Mild to Moderate Atopic Dermatitis
Official Title  ICMJE A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CRISABOROLE OINTMENT 2% IN ASIAN PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD TO MODERATE ATOPIC DERMATITIS
Brief Summary This study is a phase 3, randomized, double blind and vehicle study to evaluate the efficacy and safety of Crisaborole ointment, 2% in Asian subjects with mild to moderate atopic dermatitis involving at least 5% treatable BSA. Eligible subjects will be randomized in a 2:1 ratio to one of 2 treatment groups (Crisaborole BID, Vehicle BID, respectively).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: Crisaborole Ointment
    Crisaborole ointment 2%
  • Drug: Crisaborole Placebo Vehicle
    Placebo for crisaborole ointment
Study Arms  ICMJE
  • Experimental: Crisaborole ointment
    Crisaborole ointment application twice daily for 28 days
    Intervention: Drug: Crisaborole Ointment
  • Placebo Comparator: Crisaborole Placebo Vehicle
    Vehicle Ointment application twice daily for 28 days
    Intervention: Drug: Crisaborole Placebo Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 13, 2020)
510
Original Estimated Enrollment  ICMJE
 (submitted: April 21, 2020)
732
Estimated Study Completion Date  ICMJE November 30, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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 participated in a previous crisaborole clinical study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04360187
Other Study ID Numbers  ICMJE C3291032
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP