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

NCT04360187

Last updated date
Study Location
Zhejiang Provincial People's Hospital/Dermatology Department
Hangzhou, Zhejiang, 310014, China
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Atopic DermatitisStudy to Evaluate Safety and Tolerability of PF-07242813 in Healthy Participants and Participants With Atopic Dermatitis
NCT04668066
  1. Anaheim, California
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Atopic DermatitisAbrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic Dermatitis
NCT04564755
  1. Birmingham, Alabama
  2. Lancaster, California
  3. Long Beach, California
  4. San Diego, California
  5. Farmington, Connecticut
  6. Delray Beach, Florida
  7. Hollywood, Florida
  8. Miami, Florida
  9. Sarasota, Florida
  10. Sunrise, Florida
  11. West Dundee, Illinois
  12. Evansville, Indiana
  13. Evansville, Indiana
  14. Lexington, Kentucky
  15. Ypsilanti, Michigan
  16. Bexley, Ohio
  17. Norman, Oklahoma
  18. Rapid City, South Dakota
  19. Memphis, Tennessee
  20. Houston, Texas
  21. Morgantown, West Virginia
  22. Calgary, Alberta
  23. Markham, Ontario
  24. Peterborough, Ontario
  25. Quebec,
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Atopic DermatitisWearable Skin Sensors to Assess Nocturnal Scratch Behavior
NCT03770858
  1. Chicago, Illinois
ALL GENDERS
2 Years+
years
MULTIPLE SITES
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 CHINESE AND JAPANESE 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 21, 2020)
732
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 18, 2021
Estimated Primary Completion Date September 18, 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 China,   Japan,   Korea, Republic of
Removed Location Countries Taiwan
 
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 April 2021

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