Study to Assess Efficacy and Safety of Two Regimens of Crisaborole Ointment 2% in Japanese Participants Aged ≥2 Years With Mild to Moderate Atopic Dermatitis

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NCT03954158

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Study Location
Medical Corporation Heishinkai OPHAC Hospital
Osaka-shi, Osaka, 532-0003, Japan
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

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

By phone

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1-800-718-1021

By email

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[email protected]

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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

- Male or female participants ages; Cohort 1: 12 years and older at the time of consent. Cohort 2: 2 years to under 12 years old at the time of consent.

- Has confrimed clinical diagnosis of active AD according to Hanifin and Rajka criteria and has at least 6 months history prior to screening and has been clinically stable for more than 1 month

- Has at least 1% and no more than 30% BSA at baseline/Day1, excluding scalp, genitals and groin area

- Has a Investigator's static global assessment (ISGA) score of Mild (2) or Moderate (3) on Day 1.

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


- Has other acute or chronic medical or psychiatric condition including recent (within
the past year) or active suicidal ideation or behavior or laboratory abnormality that
may increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the participant inappropriate for entry into
this study.


- Participants had previous treatment with any topical or systemic PDE-4 inhibitor.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Assess Efficacy and Safety of Two Regimens of Crisaborole Ointment 2% in Japanese Participants Aged ?2 Years With Mild to Moderate Atopic Dermatitis
Official Title  ICMJE A Phase 2b, Multi Center, Randomized, Double-Blind, Vehicle-Controlled, Intra-Participant Study, to Evaluate Efficacy and Safety of Two Regimens of Crisaborole Ointment 2% in Japanese Pediatric and Adult Participants (2 Years and Older) With Mild to Moderate Atopic Dermatitis
Brief Summary This is a Phase 2b, multi-center, randomized, double-blind, vehicle-controlled, intraparticipant study to evaluate efficacy and safety of two regimens of crisaborole ointment 2% in Japanese pediatric and adult participants (cohort 1: 12 years and older, cohort 2: 2 to under 12 years old) with mild to moderate Atopic Dermatitis (AD).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
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 2%
    BID regimen
  • Drug: Vehicle
    BID regimen
  • Drug: Crisaborole ointment 2%
    QD regimen
  • Drug: Vehicle
    QD regimen
Study Arms  ICMJE
  • Experimental: Crisaborole ointment 2% once daily (QD) vs vehicle QD
    intra-participant comparison, treatment will be randomly assigned to target lesion 1 and lesion 2.
    Interventions:
    • Drug: Crisaborole ointment 2%
    • Drug: Vehicle
  • Experimental: Crisaborole ointment 2% twice daily (BID) vs vehicle BID
    Intra-participant comparison, treatment will be randomly assigned to target lesion 1 and lesion 2.
    Interventions:
    • Drug: Crisaborole ointment 2%
    • Drug: 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 Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2019)		81
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2019)		80
Actual Study Completion Date  ICMJE December 16, 2019
Actual Primary Completion Date December 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female participants ages; Cohort 1: 12 years and older at the time of consent. Cohort 2: 2 years to under 12 years old at the time of consent.
  • Has confrimed clinical diagnosis of active AD according to Hanifin and Rajka criteria and has at least 6 months history prior to screening and has been clinically stable for more than 1 month
  • Has at least 1% and no more than 30% BSA at baseline/Day1, excluding scalp, genitals and groin area
  • Has a Investigator's static global assessment (ISGA) score of Mild (2) or Moderate (3) on Day 1.

Exclusion Criteria:

  • Has other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • Participants had previous treatment with any topical or systemic PDE-4 inhibitor.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03954158
Other Study ID Numbers  ICMJE C3291028
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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 July 2020

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