A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis

February 1, 2022 updated by: Pfizer

A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Maintenance Treatment and Flare Reduction With Crisaborole Ointment, 2%, Once Daily Over 52 Weeks in Pediatric and Adult Participants (Ages 3 Months and Older) With Mild-to-Moderate Atopic Dermatitis, Who Responded to Twice Daily Crisaborole Ointment, 2%, Treatment

This study will evaluate crisaborole therapy once daily (QD) as a long-term topical maintenance therapy for the reduction of flare in responders to crisaborole twice daily (BID) treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Approximately 700 participants will be enrolled in an run-in period to receive crisaborole, BID for up to a maximum of 8 weeks to identify crisaborole responders. A responder is defined as a participant who achieves both ISGA and EASI50 success. ISGA success is defined as achieving a score of 0 or 1 with at least 2 grade improvement from baseline; and the EASI50 success is defined as at least 50% improvement from baseline. Non responders at the end of the 8-week run-in period will be discontinued from the study.

Approximately 250 responders will be randomized (1:1 ratio) to enter the double-blind maintenance treatment period to receive crisaborole or vehicle QD for 52 weeks, with follow-up assessments every 4 weeks. If a flare occurs and if the participant meets the criteria for having a flare (ISGA ≥2), the participant will switch to enter a flare treatment period to receive open-label crisaborole BID for up to 12 weeks with follow-up assessments every 4 weeks. If the flare has resolved (ISGA ≤1) the participant will resume maintenance treatment and respective visit schedule. If a flare does not resolve after 3 consecutive treatment courses the participant will discontinue the study. A flare treatment period may comprise up to 3 consecutive treatment courses with crisaborole BID (each course is 4 weeks).

An end of study (EOS) safety follow-up is required 4 weeks after the last study treatment of any treatment period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
494

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Maroubra, New South Wales, Australia, 2035
        • Australian Clinical Research Network
  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • SimcoDerm Medical and Surgical Dermatology Center
      • London, Ontario, Canada, N5W 6A2
        • Milestone Research , Inc
      • North York, Ontario, Canada, M2M 4J5
        • North York Research Inc.
      • Toronto, Ontario, Canada, M9W 4L6
        • Manna Research Toronto
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 2C1
        • Skinsense Medical Research
  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital of Fujian Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510091
        • Dermatology Hospital of Southern Medical University
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Dermatology Hospital of Jiangxi Province
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital Fudan University/Dermatology Department
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Tianjin Medical University General Hospital
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
      • Hangzhou, Zhejiang, China, 310009
        • Hangzhou Third Hospital
  • Israel
      • Ramat - Gan, Israel, 5265601
        • The Chaim Sheba Medical Center
  • Turkey
      • Istanbul, Turkey, 34093
        • Bezmialem Vakıf University Medical Faculty
      • Kayseri, Turkey, 38039
        • Erciyes University Medical Faculty
  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • First OC Dermatology
      • Fremont, California, United States, 94538
        • Center For Dermatology Clinical Research, Inc.
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Asthma and Allergy Associates, PC
      • Colorado Springs, Colorado, United States, 80910
        • Colorado Springs Dermatology Clinic, PC
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Skin Care Research LLC
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc
      • Largo, Florida, United States, 33770
        • Olympian Clinical Research
      • Miami, Florida, United States, 33137
        • Baumann Cosmetic and Research Institute
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center, PC
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Meridian Clinical Research, LLC
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Great Lakes Research Group, Inc.
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Skin Specialists PC
    • Ohio
      • Dayton, Ohio, United States, 45414
        • Ohio Pediatric Research Association, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
      • Tulsa, Oklahoma, United States, 74127
        • Oklahoma State University - Center for Health Sciences
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc.
    • Texas
      • Fort Worth, Texas, United States, 76244
        • Innovate Research, LLC
      • Houston, Texas, United States, 77056
        • Austin Institute for Clinical Research
      • Pflugerville, Texas, United States, 78660
        • Austin Institute for Clinical Research, Inc.
      • Webster, Texas, United States, 77598
        • Center for Clinical Studies, LTD. LLP
    • Utah
      • South Jordan, Utah, United States, 84095
        • Jordan Valley Dermatology Center
    • Virginia
      • Burke, Virginia, United States, 22015
        • PI-Coor Clinical Research LLC
    • Washington
      • Spokane, Washington, United States, 99202
        • Dermatology Specialists of Spokane
      • Spokane, Washington, United States, 99204
        • Principle Research Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female
  • 3 months of age and older
  • Confirmed diagnosis of atopic dermatitis according to Hanifin and Rajka criteria
  • Minimum of 5% BSA affected by atopic dermatitis
  • ISGA score of Mild (2) or Moderate (3)

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Crisaborole 2%
Crisaborole 2% ointment applied once daily (QD)
Drug: Crisaborole 2%
Crisaborole ointment 2%
Placebo Comparator: Vehicle
Vehicle ointment applied once daily (QD)
Drug: Vehicle
Vehicle ointment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Flare-free maintenance
Time Frame: 52 Weeks
Flare-free maintenance up until the onset of the first flare during the maintenance period. A flare is defined as a score of 2 or more on the Investigator Static Global Assessment (ISGA).
52 Weeks
Incidence of treatment emergent adverse events
Time Frame: 52 weeks
Incidence of treatment emergent adverse events over 52 weeks
52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of flare-free days
Time Frame: 52 Weeks
Number of flare-free days over 52 weeks
52 Weeks
Number of flares
Time Frame: 52 Weeks
Number of flares over 52 weeks
52 Weeks
Pruritus response maintenance
Time Frame: 52 Weeks
Maintenance of pruritus scores of ≥50% until onset of first flare. A flare is defined as a score of ≥2 on the Investigator's Static Global Assessment (ISGA).
52 Weeks
Eczema Area and Severity Index (EASI) response maintenance
Time Frame: 52 weeks
Maintenance of ≥50% reduction in Eczema Area and Severity Index (EASI50) over 52 weeks
52 weeks
Patient-reported outcome response maintenance
Time Frame: 52 weeks
Maintenance of Dermatology Quality of Life Assessments (DQoL) over 52 weeks
52 weeks
Patient-reported outcome response maintenance
Time Frame: 52 weeks
Maintenance of Patient Oriented Eczema Measure (POEM) over 52 weeks
52 weeks
Severity of flares
Time Frame: 52 weeks
Severity of flare on Investigator's Static Global Assessment (ISGA)
52 weeks
Severity of flares
Time Frame: 52 weeks
Severity of flare on Eczema Area and Severity Index (EASI)
52 weeks
Duration of flares
Time Frame: 52 weeks
Duration of flare episodes over 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 19, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 19, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C3291035
  • 2019-000443-28 (EudraCT Number)
  • CRISADE CONTROL (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atopic Dermatitis

Clinical Trials on Crisaborole 2%

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings