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A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD

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ClinicalTrials.gov Identifier: NCT03539601
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%; crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice daily (BID) in subjects who are at least 2 years of age with mild-moderate AD.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Crisaborole ointment, 2% Drug: Hydrocortisone butyrate cream, 0.1% Drug: Pimecrolimus cream, 1% Drug: Crisaborole Vehicle Phase 4

Detailed Description:

Approximately 600 subjects will be enrolled in the study, of which at least 150 subjects aged 2-6; at least 140 subjects aged 7-11; at least 120 subjects aged 12-17 and up to 90 subjects will be adults. Subjects must have mild-moderate AD involving at least 5% treatable %BSA assessed on baseline/Day 1. Treatable %BSA will be defined as the percent of a subject's total body surface area that is AD involved, excluding the scalp.

Eligible subjects will be randomized at the Baseline/Day 1 visit. Randomization will be stratified by eligibility for TCS or TCI treatment as per national approved labels. Cohort 1 will be for subjects who are eligible for TCS therapy, and Cohort 2 will be for subjects who are not eligible for TCS therapy but eligible for TCI therapy. The investigational products will be applied BID for 28 days to the Treatable body surface area (BSA) identified at Baseline/Day 1.

The primary efficacy endpoint is the percent change from baseline in the Eczema Area and Severity Index (EASI) total score at Day 29.

For the efficacy comparison of crisaborole versus vehicle, subjects from both Cohort 1 and Cohort 2 are included in the analysis, adjusted for cohort effect. For the efficacy comparison of crisaborole versus TCS, only subjects from Cohort 1 are included in the analysis. For the comparison of crisaborole versus TCI, only subjects from Cohort 2 are included in the analysis.

Safety and efficacy assessments will be conducted at the investigator site by a clinical assessor blinded to treatment assignment.

Scheduled study visits for all subjects will occur at Screening, Baseline/Day 1, Day 8, Day 15, Day 22, Day 29 (End of treatment/Early termination). A follow up telephone call will be made by site staff to the subjects/subject's legally acceptable guardian(s) on Day 36 and Day 60.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

The investigational products above are masked for appearance, and will be placed into identical cartons. Once removed from the product cartons, the investigational products could be discerned from each other based on commercial product tube shape/size and should only be handled by unblinded site personnel.

Safety and efficacy assessments will be conducted at the investigator site by a clinical assessor blinded to treatment assignment.

Primary Purpose: Treatment
Official Title: A PHASE 3B/4, MULTICENTER, RANDOMIZED, ASSESSOR BLINDED, VEHICLE AND ACTIVE (TOPICAL CORTICOSTEROID AND CALCINEURIN INHIBITOR) CONTROLLED, PARALLEL GROUP STUDY OF THE EFFICACY, SAFETY, AND LOCAL TOLERABILITY OF CRISABOROLE OINTMENT, 2% IN PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD TO MODERATE ATOPIC DERMATITIS
Actual Study Start Date : April 27, 2018
Estimated Primary Completion Date : May 25, 2020
Estimated Study Completion Date : May 25, 2020

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%
This treatment arm will be administered both in Cohort 1 and Cohort 2.
Drug: Crisaborole ointment, 2%
Applied twice a day (BID)
Other Name: Eucrisa

Active Comparator: Hydrocortisone butyrate cream, 0.1%
This treatment arm will be administered in Cohort 1 only.
Drug: Hydrocortisone butyrate cream, 0.1%
Applied BID
Other Name: Locoid 0.1%

Active Comparator: Pimecrolimus cream, 1%
This treatment arm will be administered in Cohort 2 only.
Drug: Pimecrolimus cream, 1%
Applied BID
Other Name: Elidel

Placebo Comparator: Crisaborole Vehicle
This treatment arm will be administered both in Cohort 1 and Cohort 2.
Drug: Crisaborole Vehicle
Applied BID




Primary Outcome Measures :
  1. Percent change from Baseline in the Eczema Area and Severity Index (EASI) total score at Day 29. [ Time Frame: Day 1 (Baseline), Day 29 (end of treatment/early termination). ]
    The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.

  2. Number of subjects with incidence of treatment emergent adverse events and serious adverse events. [ Time Frame: Screening ]
    Incidence of treatment emergent AEs and SAEs. This includes local tolerability, discontinuations and clinically significant changes in vital signs and clinical laboratory parameters. The investigator is to record all directly observed AE's and all AE's spontaneously reported by the subject (or subject's legal guardian). In addition, each study subject (or subject's legal guardian) will be questioned about the occurence of AE's in a non-leading manner.

  3. Number of subjects with incidence of treatment emergent adverse events and serious adverse events. [ Time Frame: Day 1 (Baseline) ]
    Incidence of treatment emergent AEs and SAEs. This includes local tolerability, discontinuations and clinically significant changes in vital signs and clinical laboratory parameters. The investigator is to record all directly observed AE's and all AE's spontaneously reported by the subject (or subject's legal guardian). In addition, each study subject (or subject's legal guardian) will be questioned about the occurence of AE's in a non-leading manner.

  4. Number of subjects with incidence of treatment emergent adverse events and serious adverse events. [ Time Frame: Day 8 ]
    Incidence of treatment emergent AEs and SAEs. This includes local tolerability, discontinuations and clinically significant changes in vital signs and clinical laboratory parameters. The investigator is to record all directly observed AE's and all AE's spontaneously reported by the subject (or subject's legal guardian). In addition, each study subject (or subject's legal guardian) will be questioned about the occurence of AE's in a non-leading manner.

  5. Number of subjects with incidence of treatment emergent adverse events and serious adverse events. [ Time Frame: Day 15 ]
    Incidence of treatment emergent AEs and SAEs. This includes local tolerability, discontinuations and clinically significant changes in vital signs and clinical laboratory parameters. The investigator is to record all directly observed AE's and all AE's spontaneously reported by the subject (or subject's legal guardian). In addition, each study subject (or subject's legal guardian) will be questioned about the occurence of AE's in a non-leading manner.

  6. Number of subjects with incidence of treatment emergent adverse events and serious adverse events. [ Time Frame: Day 22 ]
    Incidence of treatment emergent AEs and SAEs. This includes local tolerability, discontinuations and clinically significant changes in vital signs and clinical laboratory parameters. The investigator is to record all directly observed AE's and all AE's spontaneously reported by the subject (or subject's legal guardian). In addition, each study subject (or subject's legal guardian) will be questioned about the occurence of AE's in a non-leading manner.

  7. Number of subjects with incidence of treatment emergent adverse events and serious adverse events. [ Time Frame: Day 29 (end of treatment/early termination) ]
    Incidence of treatment emergent AEs and SAEs. This includes local tolerability, discontinuations and clinically significant changes in vital signs and clinical laboratory parameters. The investigator is to record all directly observed AE's and all AE's spontaneously reported by the subject (or subject's legal guardian). In addition, each study subject (or subject's legal guardian) will be questioned about the occurence of AE's in a non-leading manner.

  8. Number of subjects with incidence of treatment emergent adverse events and serious adverse events. [ Time Frame: Day 36 ]
    Incidence of treatment emergent AEs and SAEs. This includes local tolerability, discontinuations and clinically significant changes in vital signs and clinical laboratory parameters. The investigator is to record all directly observed AE's and all AE's spontaneously reported by the subject (or subject's legal guardian). In addition, each study subject (or subject's legal guardian) will be questioned about the occurence of AE's in a non-leading manner.

  9. Number of subjects with incidence of treatment emergent adverse events and serious adverse events. [ Time Frame: Day 60 (end of study) ]
    Incidence of treatment emergent AEs and SAEs. This includes local tolerability, discontinuations and clinically significant changes in vital signs and clinical laboratory parameters. The investigator is to record all directly observed AE's and all AE's spontaneously reported by the subject (or subject's legal guardian). In addition, each study subject (or subject's legal guardian) will be questioned about the occurence of AE's in a non-leading manner.

  10. Number of subjects with clinically significant change from baseline in vital signs [ Time Frame: Screening, Day 1 (Baseline), Day 29 (end of treatment/early termination) ]
    Vital sign measurements (temperature, respiratory rate, pulse rate and blood pressure) should be performed with the subject in the seated or lying position and after the subject has been sitting or lying calmly for a minimum of 5 minutes. The position of recording must be consistent within subject through-out the study. On study day visits when clinical laboratory tests are performed, assessment of vital signs should precede blood draw.

  11. Number of subjects with clinically significant change from baseline in clinical laboratory parameters. [ Time Frame: Screening, Day 1 (Baseline), Day 29 (end of treatment/early termination) ]
    Laboratory parameters include: Hematology (Hemoglobin, Hematocrit, Red blood cell count, Platelet count White blood cell count [% and absolute], Neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes) chemistry (Blood urea nitrogen/Urea, Glucose (non fasting), Creatinine, Sodium, Potassium, Chloride, Bicarbonate or Total CO2, Alanine aminotransferase , Aspartate aminotransferase , Total bilirubin Alkaline phosphatase, Albumin, Total protein). Clinical significance of laboratory parameters will be determined at the investigator's discretion.


Secondary Outcome Measures :
  1. Percent change from baseline in EASI total score by scheduled timepoints except Day 29. [ Time Frame: Day 1 (Baseline), Day 8, Day 15, Day 22 ]
    The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.

  2. Proportion of subjects achieving success in the Investigator's Static Global Assessment (ISGA) (defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2 grade improvement from Baseline) by scheduled time points. [ Time Frame: Day 1 (Baseline) ]
    ISGA assessed the severity of AD (except scalp) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting).

  3. Proportion of subjects achieving success in the Investigator's Static Global Assessment (ISGA) (defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2 grade improvement from Baseline) by scheduled time points. [ Time Frame: Day 8 ]
    ISGA assessed the severity of AD (except scalp) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting).

  4. Proportion of subjects achieving success in the Investigator's Static Global Assessment (ISGA) (defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2 grade improvement from Baseline) by scheduled time points. [ Time Frame: Day 15 ]
    ISGA assessed the severity of AD (except scalp) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting).

  5. Proportion of subjects achieving success in the Investigator's Static Global Assessment (ISGA) (defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2 grade improvement from Baseline) by scheduled time points. [ Time Frame: Day 22 ]
    ISGA assessed the severity of AD (except scalp) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting).

  6. Proportion of subjects achieving success in the Investigator's Static Global Assessment (ISGA) (defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2 grade improvement from Baseline) by scheduled time points. [ Time Frame: Day 29 (end of treatment/early termination). ]
    ISGA assessed the severity of AD (except scalp) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting).

  7. Proportion of subjects with ISGA score of clear (0) or almost clear (1) by scheduled time points. [ Time Frame: Day 1 (Baseline) ]
    ISGA assessed the severity of AD (except scalp) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting).

  8. Proportion of subjects with ISGA score of clear (0) or almost clear (1) by scheduled time points. [ Time Frame: Day 8 ]
    ISGA assessed the severity of AD (except scalp) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting).

  9. Proportion of subjects with ISGA score of clear (0) or almost clear (1) by scheduled time points. [ Time Frame: Day 15 ]
    ISGA assessed the severity of AD (except scalp) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting).

  10. Proportion of subjects with ISGA score of clear (0) or almost clear (1) by scheduled time points. [ Time Frame: Day 22 ]
    ISGA assessed the severity of AD (except scalp) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting).

  11. Proportion of subjects with ISGA score of clear (0) or almost clear (1) by scheduled time points. [ Time Frame: Day 29 (end of treatment/early termination) ]
    ISGA assessed the severity of AD (except scalp) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting).

  12. Proportion of patients with EASI75 (75% improvement from Baseline) by scheduled time points. [ Time Frame: Day 1 (Baseline) ]
    The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The endpoint is defined as the proportion of subjects with improvement of ≥75% in EASI score from baseline.

  13. Proportion of patients with EASI75 (75% improvement from Baseline) by scheduled time points. [ Time Frame: Day 8 ]
    The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.

  14. Proportion of patients with EASI75 (75% improvement from Baseline) by scheduled time points. [ Time Frame: Day 15 ]
    The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.

  15. Proportion of patients with EASI75 (75% improvement from Baseline) by scheduled time points. [ Time Frame: Day 22 ]
    The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.

  16. Proportion of patients with EASI75 (75% improvement from Baseline) by scheduled time points. [ Time Frame: Day 29 (end of treatment/early termination) ]
    The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.

  17. Change from Baseline in % BSA by scheduled time points. [ Time Frame: Screening, Day 1 (Baseline), Day 8, Day 15, Day 22, Day 29 (end of treatment/early termination) ]
    The number of handprints of AD skin in a body region can be used to determine the extent (%) to which a body region is involved with atopic dermatitis. The area represented by the palmar surface of the subject's hand with all five digits adductedtogether, is approximately 1% of the subject's BSA, regardless of hte subject's age.

  18. Change from Baseline in Dermatitis Family Impact Questionnaire (DFI) (Completed by parent/caregiver of Subjects 2-17 years) by scheduled time points. [ Time Frame: Day 1 (Baseline), Day 8, Day 15, Day 22, Day 29 (end of treatment/early termination) ]
    The DFI is a 10-item disease questionnaire that measures the impact of having a child with AD on family quality of life. It is completed by parent/legal guardian of the child (affected by AD), based on recall over the past week. Each question is scored on a 4-point scale ranging from 0 (good) to 3 (worst), where higher scores indicated worst quality of life of family. The DFI total score is the sum of individual scores of the 10 questions and ranges from 0 (good) to 30 (worst), where higher DFI scores indicated worst quality of life of family.

  19. Change from Baseline in Dermatology Life Quality Index (DLQI) (for Subjects 16 years and older), by scheduled time points. [ Time Frame: Day 1 (Baseline), Day 8, Day 15, Day 22, Day 29 (end of treatment/early termination) ]
    The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question is evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

  20. Time to EASI75. [ Time Frame: Day 1 (Baseline) ]
    The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. Time to improvement in EASI75 is defined the time interval between the administration of first dose of study drug till improvement of ≥75% in EASI score.

  21. Time to EASI75. [ Time Frame: Day 8 ]
    The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. Time to improvement in EASI75 is defined the time interval between the administration of first dose of study drug till improvement of ≥75% in EASI score.

  22. Time to EASI75. [ Time Frame: Day 15 ]
    The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. Time to improvement in EASI75 is defined the time interval between the administration of first dose of study drug till improvement of ≥75% in EASI score.

  23. Time to EASI75. [ Time Frame: Day 22 ]
    The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. Time to improvement in EASI75 is defined the time interval between the administration of first dose of study drug till improvement of ≥75% in EASI score.

  24. Time to EASI75. [ Time Frame: Day 29 (end of treatment/early termination) ]
    The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. Time to improvement in EASI75 is defined the time interval between the administration of first dose of study drug till improvement of ≥75% in EASI score.

  25. Change from Baseline in Childrens Dermatology Life Quality Index (CDLQI) (for Subjects 4-15 years and older, completed by the subject with the help the caregiver, if needed), by scheduled time points. [ Time Frame: Day 1 (Baseline), Day 8, Day 15, Day 22, Day 29 (end of treatment/early termination) ]
    The CDLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question is evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

  26. Change from Baseline in Peak Pruritus Numerical Rating Scale (NRS) by scheduled time points (Version for Subjects 12 years and older). [ Time Frame: Once Daily from Day 1 (Baseline) to Day 29 (end of treatment/early termination) ]
    Participant-rated pruritus score of the severity of pruritus due to AD, suffered in the past 24 hours on an 11-point Numeric Rating Score (NRS) where 0 is no itch and 10 is worst itch imaginable. Change: score at observation minus score at baseline.

  27. Time to ≥2 point improvement from Baseline in Peak Pruritus NRS (Subjects 12 years and older). [ Time Frame: Once Daily from Day 1 (Baseline) to Day 29 (end of treatment/early termination) ]
    Time to improvement in pruritus is defined as the time interval between the administration of first dose of study drug till the first documentation of ≥2 point improvement in pruritus.

  28. Time to ≥3 point improvement from Baseline in Peak Pruritus NRS (Subjects 12 years and older). [ Time Frame: Once Daily from Day 1 (Baseline) to Day 29 (end of treatment/early termination). ]
    Time to improvement in pruritus is defined as the time interval between the administration of first dose of study drug till the first documentation of ≥3 point improvement in pruritus.

  29. Proportion of subjects with ≥2 point improvement from Baseline in Peak Pruritus NRS (Subjects 12 years and older). [ Time Frame: Once Daily from Day 1 (Baseline) to Day 29 (end of treatment/early termination). ]
    Proportion of subjects with documented ≥2 point improvement in pruritus.

  30. Proportion of subjects with ≥3 point improvement from Baseline in Peak Pruritus NRS (Subjects 12 years and older). [ Time Frame: Once Daily from Day 1 (Baseline) to Day 29 (end of treatment/early termination). ]
    Proportion of subjects with documented ≥3 point improvement in pruritus.

  31. Change from Baseline in Itch Severity Scale by scheduled time points (Version for Subjects ≥6 and <12 years). [ Time Frame: Once Daily from Day 1 (Baseline) to Day 29 (end of treatment/early termination). ]
    Participant-rated itch score of the severity of itch due to AD suffered today, where 0 is Not itchy and 4 is Very itchy. Change: score at observation minus score at baseline.

  32. Change from Baseline in Itch Severity NRS by scheduled time points (Observer version for Subjects <6 years). [ Time Frame: Once Daily from Day 1 (Baseline) to Day 29 (end of treatment/early termination). ]
    Observer-rated itch score of the severity of itch due to AD, suffered in the past 24 hours on an 11-point observer Itch Severity Numeric Rating Score (NRS) where 0 is no itch and 10 is worst itch imaginable. Change: score at observation minus score at baseline.

  33. Time ≥2 point to improvement from Baseline in Itch Severity NRS (Observer version for Subjects <6 years) [ Time Frame: Once Daily from Day 1 (Baseline) to Day 29 (end of treatment/early termination). ]
    Time to improvement in itch is defined as the time interval between the administration of first dose of study drug till the first documentation of ≥2 point improvement in itch.

  34. Time ≥3 point to improvement from Baseline in Itch Severity NRS (Observer version for Subjects <6 years). [ Time Frame: Once Daily from Day 1 (Baseline) to Day 29 (end of treatment/early termination). ]
    Time to improvement in itch is defined as the time interval between the administration of first dose of study drug till the first documentation of ≥3 point improvement in itch.

  35. Proportion of subjects with ≥2 point improvement from Baseline in Itch Severity NRS (Observer version for Subjects <6 years). [ Time Frame: Once Daily from Day 1 (Baseline) to Day 29 (end of treatment/early termination). ]
    Proportion of subjects with documented ≥2 point improvement in itch.

  36. Proportion of subjects with ≥3 point improvement from Baseline in Itch Severity NRS (Observer version for Subjects <6 years). [ Time Frame: Once Daily from Day 1 (Baseline) to Day 29 (end of treatment/early termination). ]
    Proportion of subjects with documented ≥3 point improvement in itch.



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.


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

Inclusion Criteria:

Is male or female 2 years and older at the Screening visit/time of informed consent/assent diagnosed with mild-moderate AD (according to the criteria of Hanifin and Rajka), of at least 5% BSA.

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.

Subjects in Cohort 1 are excluded if they have a contraindication for treatment with hydrocortisone butyrate cream 0.1%

Subjects in Cohort 2 are excluded if they have a contraindication for treatment with pimecrolimus cream, 1%


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): NCT03539601


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, Arkansas
Dermatology Trial Associates Recruiting
Bryant, Arkansas, United States, 72022
United States, California
California Dermatology & Clinical Research Institute Recruiting
Encinitas, California, United States, 92024
United States, Florida
Park Avenue Dermatology Recruiting
Orange Park, Florida, United States, 32073
ForCare Clinical Research Recruiting
Tampa, Florida, United States, 33613
United States, Kentucky
DS Research Recruiting
Louisville, Kentucky, United States, 40241
United States, North Carolina
M3-Wake Research, Inc. Recruiting
Raleigh, North Carolina, United States, 27612
United States, Texas
Arlington Research Center Inc Recruiting
Arlington, Texas, United States, 76011
United States, Virginia
Virginia Clinical Research, Inc Recruiting
Norfolk, Virginia, United States, 23502
Belgium
CHU de Liege - Domaine Universitaire du Sart- Tilman B35 Not yet recruiting
Liege, Belgium, 4000
Germany
Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie, Dermatologische Ambulanz Not yet recruiting
Bad Bentheim, Niedersachsen, Germany, 48455
Universitatsklinikum Schleswig-Holstein, Campus Lubeck Not yet recruiting
Lubeck, Schleswig-holstein, Germany, 23538
ISA - Interdisciplinary Study Association GmbH Recruiting
Berlin, Germany, 10789
Italy
Ospedale San Pietro Fatebenefratelli Not yet recruiting
Roma, RM, Italy, 00189
Poland
Krakowskie Centrum Medyczne sp. z o.o. Recruiting
Krakow, Poland, 31-501
MTZ Clinical Research Sp. z o.o. Not yet recruiting
Warszawa, Poland, 02-106
Klinika Ambroziak Sp. z O. O. Not yet recruiting
Warszawa, Poland, 02-758
ROYALDERM Agnieszka Nawrocka Not yet recruiting
Warszawa, Poland, 02-962
Sweden
Barn och Ungdomskliniken Not yet recruiting
Orebro, Sweden, 701 85
Avdelningen for Kliniska Provningar Not yet recruiting
Orebro, Sweden, 703 62
United Kingdom
Rame Medical Ltd Recruiting
Torpoint, Cornwall, United Kingdom, PL11 2TB
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03539601     History of Changes
Other Study ID Numbers: C3291037
2018-001043-31 ( EudraCT Number )
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 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

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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:
Atopic Dermatitis, Crisaborole ointment 2%, TCS, TCI

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Pimecrolimus
Calcineurin Inhibitors
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors