Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 90 of 157 for:    Dermatitis, Atopic, 8

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03954158
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Crisaborole ointment 2% Drug: Vehicle Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 15, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Crisaborole

Arm Intervention/treatment
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.
Drug: Crisaborole ointment 2%
QD regimen

Drug: Vehicle
QD regimen

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.
Drug: Crisaborole ointment 2%
BID regimen

Drug: Vehicle
BID regimen




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  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).

  3. 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).

  4. 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).

  5. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954158


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Layout table for location information
Japan
Medical Corporation Heishinkai OPHAC Hospital Active, not recruiting
Osaka-shi, Osaka, Japan, 532-0003
Fukuwa Clinic Recruiting
Chuo-ku, Tokyo, Japan, 103-0027
Sekino Hospital Active, not recruiting
Toshima-ku, Tokyo, Japan, 171-0014
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03954158     History of Changes
Other Study ID Numbers: C3291028
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases