Clinical trial NCT04040192: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Eczema
Crisaborole
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-07-31
Enrollment: 620
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Duration of Flare-Free Maintenance Until Onset of First-Flare During the Double Blind (DB) Period
timeFrame: From randomization to first flare or last ISGA assessment (up to 52 weeks)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: 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:
measure: Number of Flare-Free Days During the DB Period
timeFrame: Up to maximum of 52 weeks
measure: Number of Flares During the DB Period
timeFrame: Up to maximum of 52 weeks
measure: 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
timeFrame: From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)
measure: 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
timeFrame: From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)
measure: 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
timeFrame: From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)
measure: Duration of Maintenance of >=50% Reduction in Eczema Area and Severity Index (EASI) Total Score Until Onset of First Flare During the DB Period
timeFrame: From randomization to loss of EASI response or onset of first flare or the last EASI assessment (up to maximum of 52 weeks)
measure: Duration of Maintenance of Dermatology Life Quality Index (DLQI) Response Until Onset of First Flare During the DB Period
timeFrame: From randomization to loss of DLQI response or onset of first flare or the last assessment up to first flare (up to maximum of 52 weeks)
measure: Duration of Maintenance of Patient Oriented Eczema Measure (POEM) Response Until Onset of First Flare During the DB Period
timeFrame: From randomization to loss POEM response or onset of first flare or the last assessment up to the first flare (up to maximum of 52 weeks)
measure: Investigator's Static Global Assessment (ISGA) Score for the First Flare Period
timeFrame: Week 0 (Day 1), Week 4, Week 8 and Week 12
measure: EASI Score for the First Flare Period
timeFrame: Week 0 (Day 1), Week 4, Week 8 and Week 12
measure: Duration (Days) of Flare Period
timeFrame: Up to 52 weeks
measure: Percent Change From Baseline in EASI Scores at Weeks 2, 4, 6 and 8: OL Run-in Period
timeFrame: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
measure: Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period
timeFrame: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period
timeFrame: Baseline (last observation up to and including the randomization day of DB period),Weeks 0, 4, 8 and 12
measure: Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period
timeFrame: Baseline (last observation up to and including the randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Change From Baseline in ISGA Scores at Weeks 2, 4, 6 and 8 for OL run-in Period
timeFrame: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
measure: Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period
timeFrame: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period
timeFrame: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period
timeFrame: Baseline (last observation up to and including the randomization day), Weeks 0, 4, 8 and 12
measure: Change From Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period
timeFrame: Baseline (last observation up to and including the randomization day) Weeks 2, 4, 6 and 8
measure: Change From Baseline in Treatable %BSA: DB Period
timeFrame: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Change From Baseline in Treatable %BSA: First Flare Free Period
timeFrame: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Change From Baseline in Treatable %BSA: First Flare Period
timeFrame: Baseline (last observation up to and including the randomization day), Weeks 0, 4, 8 and 12
measure: Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period
timeFrame: Baseline (last observation up to and including the randomization day), Weeks 24 and 52
measure: Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period
timeFrame: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
measure: Night Time Itch Score for Participants >=12 Years of Age: DB Period
timeFrame: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Night Time Itch Score for Participants >=12 Years of Age: First Flare Period
timeFrame: Weeks 0, 4, 8 and 12
measure: Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
timeFrame: Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: AD Skin Pain Scores for Participants >=12 Years of Age: OL Run-in Period
timeFrame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
measure: AD Skin Pain Scores for Participants >=12 Years of Age: DB Period
timeFrame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period
timeFrame: Weeks 0, 4, 8, 12
measure: AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period
timeFrame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Patient/Observer Global Impression of Severity Score: OL Run-in Period
timeFrame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
measure: Patient/Observer Global Impression of Severity Score: DB Period
timeFrame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Patient/Observer Global Impression of Severity Score: First Flare Period
timeFrame: Weeks 0, 4, 8 and 12
measure: Patient/Observer Global Impression of Severity Score: First Flare Free Period
timeFrame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Patient/Observer Global Impression of Change Score: OL Run-in Period
timeFrame: Weeks 2, 4, 6 and 8
measure: Patient/Observer Global Impression of Change Score: DB Period
timeFrame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Patient/Observer Global Impression of Change Score: First Flare Period
timeFrame: Weeks 0, 4, 8 and 12
measure: Patient/Observer Global Impression of Change Score: First Flare Free Period
timeFrame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
timeFrame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
measure: Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
timeFrame: Baseline (the last observation up to and including Day 1 of DB period),Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
timeFrame: Weeks 0, 4, 8 and 12
measure: Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
timeFrame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: European Quality of Life-5 Dimension 5-Level (EQ-5D-5L) Index Score in Participants Greater Than or Equal to (>=) 18 Years of Age: OL Run-in Period
timeFrame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
measure: European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Participants Between 8-17 Years of Age: OL Run-in Period
timeFrame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
measure: EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: OL Run-in Period
timeFrame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
measure: EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Participants >= 18 Years of Age: OL Run-in Period
timeFrame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
measure: EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age : OL-Run-in Period
timeFrame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
measure: EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: OL Run-in Period
timeFrame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
measure: EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period
timeFrame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period
timeFrame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period
timeFrame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period
timeFrame: Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period
timeFrame: Baseline (the last observation up to and including Day 1 of OL period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period
timeFrame: Baseline (the last observation up to and including Day 1 of DB period),Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period
timeFrame: Weeks 0, 4, 8 and 12
measure: EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period
timeFrame: Weeks 0, 4, 8 and 12
measure: EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period
timeFrame: Weeks 0, 4, 8 and 12
measure: EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period
timeFrame: Weeks 0, 4, 8 and 12
measure: EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period
timeFrame: Weeks 0, 4, 8 and 12
measure: EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period
timeFrame: Weeks 0, 4, 8 and 12
measure: EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period
timeFrame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period
timeFrame: Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period
timeFrame: Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period
timeFrame: Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period
timeFrame: Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period
timeFrame: Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Work Time Missed Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
timeFrame: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
measure: Percent Impairment While Working Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
timeFrame: Weeks 0, 2, 4, 6 and 8
measure: Percent Overall Work Impairment Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
timeFrame: Weeks 0, 2, 4, 6 and 8
measure: Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
timeFrame: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
measure: Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
timeFrame: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
measure: Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
timeFrame: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
measure: Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
timeFrame: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
measure: Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
timeFrame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
timeFrame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
timeFrame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
timeFrame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
timeFrame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
timeFrame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
timeFrame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
timeFrame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
timeFrame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
timeFrame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
timeFrame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
timeFrame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
timeFrame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
timeFrame: Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
timeFrame: Weeks 0, 4, 8 and 12
measure: Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
timeFrame: Weeks 0, 4, 8 and 12
measure: Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
timeFrame: Weeks 0, 4, 8 and 12
measure: Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
timeFrame: Weeks 0, 4, 8 and 12
measure: Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
timeFrame: Weeks 0, 4, 8 and 12
measure: Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
timeFrame: Weeks 0, 4, 8 and 12
measure: Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
timeFrame: Weeks 0, 4, 8 and 12
measure: Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period
timeFrame: Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
measure: Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period
timeFrame: Baseline (last observation up to and including randomization day), Week 8, 16, 32 and end of treatment [Week 52]
measure: Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period
timeFrame: Weeks 0, 4, 8 and 12
measure: Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period
timeFrame: Baseline (last observation up to and including the randomization day of DB period), Weeks 8, 16 and 32
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates, PC
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Dermatology Clinic, PC
state: Colorado
city: Boca Raton
country: United States
facility: Skin Care Research LLC
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Largo
country: United States
facility: Olympian Clinical Research
state: Florida
city: Miami
country: United States
facility: Baumann Cosmetic and Research Institute
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Baton Rouge
country: United States
facility: Meridian Clinical Research, LLC
state: Louisiana
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Omaha
country: United States
facility: Skin Specialists PC
state: Nebraska
city: Dayton
country: United States
facility: Ohio Pediatric Research Association, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma State University - Center for Health Sciences
state: Oklahoma
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Fort Worth
country: United States
facility: Innovate Research, LLC
state: Texas
city: Houston
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies, LTD. LLP
state: Texas
city: South Jordan
country: United States
facility: Jordan Valley Dermatology Center
state: Utah
city: Burke
country: United States
facility: PI-Coor Clinical Research LLC
state: Virginia
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane
state: Washington
city: Spokane
country: United States
facility: Principle Research Solutions
state: Washington
city: Maroubra
country: Australia
facility: Australian Clinical Research Network
state: New South Wales
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: London
country: Canada
facility: Milestone Research , Inc
state: Ontario
city: North York
country: Canada
facility: North York Research Inc.
state: Ontario
city: Toronto
country: Canada
facility: Manna Research Toronto
state: Ontario
city: Saskatoon
country: Canada
facility: Skinsense Medical Research
state: Saskatchewan
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Nanchang
country: China
facility: Dermatology Hospital of Jiangxi Province
state: Jiangxi
city: Shanghai
country: China
facility: Huashan Hospital Fudan University/Dermatology Department
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Hangzhou Third Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Ramat - Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University Medical Faculty
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: