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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

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ClinicalTrials.gov Identifier: NCT04040192
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : February 3, 2022
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Crisaborole 2% Drug: Vehicle Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 494 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 12, 2019
Actual Primary Completion Date : January 19, 2022
Actual Study Completion Date : January 19, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Crisaborole

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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).

  2. Incidence of treatment emergent adverse events [ Time Frame: 52 weeks ]
    Incidence of treatment emergent adverse events over 52 weeks

Secondary Outcome Measures :
  1. Number of flare-free days [ Time Frame: 52 Weeks ]
    Number of flare-free days over 52 weeks

  2. Number of flares [ Time Frame: 52 Weeks ]
    Number of flares over 52 weeks

  3. 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).

  4. 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

  5. Patient-reported outcome response maintenance [ Time Frame: 52 weeks ]
    Maintenance of Dermatology Quality of Life Assessments (DQoL) over 52 weeks

  6. Patient-reported outcome response maintenance [ Time Frame: 52 weeks ]
    Maintenance of Patient Oriented Eczema Measure (POEM) over 52 weeks

  7. Severity of flares [ Time Frame: 52 weeks ]
    Severity of flare on Investigator's Static Global Assessment (ISGA)

  8. Severity of flares [ Time Frame: 52 weeks ]
    Severity of flare on Eczema Area and Severity Index (EASI)

  9. Duration of flares [ Time Frame: 52 weeks ]
    Duration of flare episodes over 52 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

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): NCT04040192

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Sponsors and Collaborators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04040192    
Other Study ID Numbers: C3291035
2019-000443-28 ( EudraCT Number )
CRISADE CONTROL ( Other Identifier: Alias Study Number )
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: February 2022
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases