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
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
3 other identifiers
interventional
620
6 countries
44
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2019
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2019
CompletedFirst Posted
Study publicly available on registry
July 31, 2019
CompletedStudy Start
First participant enrolled
September 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2022
CompletedResults Posted
Study results publicly available
March 8, 2023
CompletedMarch 8, 2023
February 1, 2023
2.4 years
July 30, 2019
December 20, 2022
February 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Duration of Flare-Free Maintenance Until Onset of First-Flare During the Double Blind (DB) Period
The duration of flare-free maintenance was the time from randomization to the last Investigator's Static Global Assessment (ISGA) and was right censored, if an intercurrent event (eg, death, dropout, loss to follow up, or end of study) occurred before the first flare. When a flare occurred first, the duration of flare free maintenance was the time from randomization to the first flare and was not censored. Duration of flare free maintenance was estimated using the Kaplan-Meier method.
From randomization to first flare or last ISGA assessment (up to 52 weeks)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started on or after the treatment period start date and before end of study (at least 28 days after last dose of study intervention).
Crisaborole 2% BID: From start of study intervention in OL period up to 8 weeks ; Vehicle QD and crisaborole 2% QD: From start of study intervention in DB period up to 28 days after last dose of study intervention (maximum of 56 weeks)
Secondary Outcomes (100)
Number of Flare-Free Days During the DB Period
Up to maximum of 52 weeks
Number of Flares During the DB Period
Up to maximum of 52 weeks
Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged >=12 Years With Baseline Peak Pruritus Numerical Rating Scale (PP NRS) >=3, >=4 and >=3, >=4 Points Reduction in PP NRS
From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)
Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged 6 to <12 Years With Baseline Patient Reported Itch Severity (PRIS) >=2 and >=2 Points Reduction in PRIS
From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)
Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Observer Reported Itch Severity Scale (ORIS) in Participants Aged 3 to <6 Months
From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)
- +95 more secondary outcomes
Study Arms (2)
Crisaborole 2%
EXPERIMENTALCrisaborole 2% ointment applied once daily (QD)
Vehicle
PLACEBO COMPARATORVehicle ointment applied once daily (QD)
Interventions
Eligibility Criteria
You may qualify if:
- Male or female
- 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)
You may not qualify if:
- \- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (44)
First OC Dermatology
Fountain Valley, California, 92708, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907, United States
Colorado Springs Dermatology Clinic, PC
Colorado Springs, Colorado, 80910, United States
Skin Care Research LLC
Boca Raton, Florida, 33486, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256, United States
Olympian Clinical Research
Largo, Florida, 33770, United States
Baumann Cosmetic and Research Institute
Miami, Florida, 33137, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168, United States
Meridian Clinical Research, LLC
Baton Rouge, Louisiana, 70808, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
Skin Specialists PC
Omaha, Nebraska, 68144, United States
Ohio Pediatric Research Association, Inc.
Dayton, Ohio, 45414, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Oklahoma State University - Center for Health Sciences
Tulsa, Oklahoma, 74127, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Innovate Research, LLC
Fort Worth, Texas, 76244, United States
Austin Institute for Clinical Research
Houston, Texas, 77056, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660, United States
Center for Clinical Studies, LTD. LLP
Webster, Texas, 77598, United States
Jordan Valley Dermatology Center
South Jordan, Utah, 84095, United States
PI-Coor Clinical Research LLC
Burke, Virginia, 22015, United States
Dermatology Specialists of Spokane
Spokane, Washington, 99202, United States
Principle Research Solutions
Spokane, Washington, 99204, United States
Australian Clinical Research Network
Maroubra, New South Wales, 2035, Australia
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1, Canada
Milestone Research , Inc
London, Ontario, N5W 6A2, Canada
North York Research Inc.
North York, Ontario, M2M 4J5, Canada
Manna Research Toronto
Toronto, Ontario, M9W 4L6, Canada
Skinsense Medical Research
Saskatoon, Saskatchewan, S7K 2C1, Canada
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, 330000, China
Huashan Hospital Fudan University/Dermatology Department
Shanghai, Shanghai Municipality, 200040, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Hangzhou Third Hospital
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310016, China
The Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
Bezmialem Vakıf University Medical Faculty
Istanbul, 34093, Turkey (Türkiye)
Erciyes University Medical Faculty
Kayseri, 38039, Turkey (Türkiye)
Related Publications (2)
Eichenfield LF, Stein Gold LF, Lynde C, Guenther L, Greenberger S, Chu CY, Ghodsi Z, Vlahos B, Sanders P, Cha A, Canosa JM. Maintenance of Investigator's Static Global Assessment Response with Once-Daily Crisaborole in Participants with Mild to Moderate Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Apr;14(4):875-892. doi: 10.1007/s13555-024-01129-9. Epub 2024 Mar 28.
PMID: 38546803DERIVEDEichenfield LF, Gower RG, Xu J, Alam MS, Su JC, Myers DE, Sanders P, Vlahos B, Zang C, Lan J, Werth J. Once-Daily Crisaborole Ointment, 2%, as a Long-Term Maintenance Treatment in Patients Aged >/= 3 Months with Mild-to-Moderate Atopic Dermatitis: A 52-Week Clinical Study. Am J Clin Dermatol. 2023 Jul;24(4):623-635. doi: 10.1007/s40257-023-00780-w. Epub 2023 May 15.
PMID: 37184828DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer Inc.
- Organization
- Pfizer ClinicalTrials.gov Call Center
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2019
First Posted
July 31, 2019
Study Start
September 12, 2019
Primary Completion
January 19, 2022
Study Completion
January 19, 2022
Last Updated
March 8, 2023
Results First Posted
March 8, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
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.