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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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ClinicalTrials.gov Identifier: NCT03954158
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date July 22, 2019
Actual Study Start Date  ICMJE June 15, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
Change from baseline in Total Sign Score (TSS) in target lesions treated with crisaborole ointment or vehicle on Day 15 in each regimen for each cohort [ Time Frame: Day15 ]
To compare the efficacy of crisaborole ointment 2%, administered QD or BID relative to the corresponding vehicle (QD or BID), on TSS assessment in target lesions, in the treatment of mild to moderate AD in adults (cohort 1) and pediatrics (cohort 2).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03954158 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • Change from baseline in TSS in target lesions treated with crisaborole ointment or vehicle on Day 15 in each regimen for each cohort [ Time Frame: Day 15 ]
    To evaluate the efficacy of crisaborole ointment 2% BID relative to crisaborole ointment 2% QD, on TSS assessment in target lesions, in the treatment of mild to moderate AD in adults (cohort 1) and pediatrics (cohort 2).
  • Change from baseline in TSS in target lesions treated with crisaborole ointment or vehicle on Day 8 in each regimen for each cohort [ Time Frame: Day 8 ]
    To evaluate the efficacy of crisaborole ointment 2%, administered QD or BID, on TSS in target lesions, in the treatment of mild to moderate AD in adults (cohort 1) and pediatrics (cohort 2).
  • Change from baseline in investigator's static global assessment (ISGA) in target lesions treated with crisaborole ointment or vehicle on Day 8 and Day 15 in each regimen for each cohort [ Time Frame: Day 8, Day 15 ]
    To evaluate the efficacy of crisaborole ointment 2%, administered QD or BID, on ISGA in target lesions, in the treatment of mild to moderate AD in adults (cohort 1) and pediatrics (cohort 2).
  • Change from baseline in Pruritus assessments in target lesions treated with crisaborole ointment or vehicle at each day up to Day 15 in each regimen [ Time Frame: Up to Day 15 ]
    To evaluate the efficacy of crisaborole ointment 2%, administered QD or BID, on Pruritus assessments in target lesions, in the treatment of mild to moderate AD in adults (cohort 1) and pediatrics (cohort 2).
  • Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in each regimen for each cohort [ Time Frame: Up to Day 15 ]
    To assess the safety and local tolerability of crisaborole ointment 2%, administered QD or BID, in the treatment of mild to moderate AD in adults (cohort 1) and pediatrics (cohort 2).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2019
Estimated Primary Completion Date November 30, 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: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2019

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