Phase 3 Completed N=497 Randomized Quadruple-blind Treatment

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

Atopic Dermatitis

Source: ClinicalTrials.gov NCT04040192 ↗

Enrolled (actual)

497

Serious AEs

1.1%

Results posted

Mar 2023

Primary outcomePrimary: Duration of Flare-Free Maintenance Until Onset of First-Flare During the Double Blind (DB) Period — 30; 111 Days — p=0.0034

◆ Published Evidence

Established

41citations · ~14 / year

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.

American journal of clinical dermatology · 2023 · Open access · Likely link

Full text ↗ PubMed 37184828 ↗ +1 more ↓

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.

Linked Publications (2)

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.

American journal of clinical dermatology · 2023 · 41 citations · Open access · Likely link

Full text ↗PubMed 37184828 ↗
Maintenance of Investigator's Static Global Assessment Response with Once-Daily Crisaborole in Participants with Mild to Moderate Atopic Dermatitis.

Dermatology and therapy · 2024 · 1 citation · Open access · Likely link

Full text ↗PubMed 38546803 ↗

Outcome Measures

Outcome	Result	p-value
PRIMARY Duration of Flare-Free Maintenance Until Onset of First-Flare During the Double Blind (DB) Period	30; 111	0.0034 sig
PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs)	109; 49; 36	—
SECONDARY Number of Flare-Free Days During the DB Period	199.42; 234.01	0.0346 sig
SECONDARY Number of Flares During the DB Period	1.00; 1.00	0.0042 sig
SECONDARY 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	NA; 164; NA; 309	0.6815
SECONDARY 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	NA; 133	0.1933
SECONDARY 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	7; NA; 8; NA	0.3778
SECONDARY Duration of Maintenance of >=50% Reduction in Eczema Area and Severity Index (EASI) Total Score Until Onset of First Flare During the DB Period	198; NA	0.1159
SECONDARY Duration of Maintenance of Dermatology Life Quality Index (DLQI) Response Until Onset of First Flare During the DB Period	NA; NA; NA; NA	0.6973
SECONDARY Duration of Maintenance of Patient Oriented Eczema Measure (POEM) Response Until Onset of First Flare During the DB Period	55; 180; 20; 150	0.0513
SECONDARY Investigator's Static Global Assessment (ISGA) Score for the First Flare Period	2.4; 2.3; 2.2; 2.2; 2.1; 2.4	—
SECONDARY EASI Score for the First Flare Period	6.53; 5.27; 6.09; 5.02; 4.84; 5.66	—
SECONDARY Duration (Days) of Flare Period	54.2; 55.3	—
SECONDARY Percent Change From Baseline in EASI Scores at Weeks 2, 4, 6 and 8: OL Run-in Period	-31.44; -38.52; -45.35; -52.86	—
SECONDARY 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	2.87; -10.16; 407.52; 1.04; 34.26; 239.90	—
SECONDARY Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period	484.69; 324.54; 294.83; 293.63; 245.70; 275.66	—
SECONDARY 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	-0.46; -10.34; -21.34; 10.36; 2.24; -9.44	—
SECONDARY Change From Baseline in ISGA Scores at Weeks 2, 4, 6 and 8 for OL run-in Period	2.7; -0.5; -0.7; -0.9; -1.2	—
SECONDARY 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	0.6; 0.6; 0.2; 0.1; 1.7; 0.2	—
SECONDARY 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	0.6; 0.6; 0.2; 0.1; 0.2; 0.1	—
SECONDARY Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period	1.8; 1.7; 1.5; 1.5; 1.3; 1.6	—
SECONDARY Change From Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period	19.61; -3.86; -5.09; -6.42; -7.35	—
SECONDARY Change From Baseline in Treatable %BSA: DB Period	5.25; 5.22; 1.16; 0.52; 6.25; 0.59	—
SECONDARY Change From Baseline in Treatable %BSA: First Flare Free Period	5.25; 5.22; 1.20; 0.53; 0.21; -0.10	—
SECONDARY Change From Baseline in Treatable %BSA: First Flare Period	8.27; 4.68; 6.92; 4.17; 4.95; 3.56	—
SECONDARY Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period	14.28; 10.77; 2.29; -0.20; 1.75; -3.46	—
SECONDARY Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period	4.6; 2.9; 2.7; 2.5; 2.5; 4.4	—
SECONDARY Night Time Itch Score for Participants >=12 Years of Age: DB Period	1.9; 1.8; 2.0; 1.2; 2.2; 1.6	—
SECONDARY Night Time Itch Score for Participants >=12 Years of Age: First Flare Period	2.0; 2.0; 2.0; 2.2; 2.2; 2.8	—
SECONDARY Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period	1.9; 1.8; 2.0; 1.2; 1.8; 1.2	—
SECONDARY AD Skin Pain Scores for Participants >=12 Years of Age: OL Run-in Period	2.6; 2.0; 1.9; 1.8; 1.7	—
SECONDARY AD Skin Pain Scores for Participants >=12 Years of Age: DB Period	1.1; 1.2; 1.1; 0.7; 1.6; 1.0	—
SECONDARY AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period	1.2; 2.2; 1.4; 1.7; 1.3; 2.3	—
SECONDARY AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period	1.1; 1.2; 1.2; 0.7; 1.0; 1.0	—
SECONDARY Patient/Observer Global Impression of Severity Score: OL Run-in Period	3.8; 3.2; 3.1; 3.0; 3.0; 4.4	—
SECONDARY Patient/Observer Global Impression of Severity Score: DB Period	2.6; 2.5; 2.7; 2.3; 3.0; 2.6	—
SECONDARY Patient/Observer Global Impression of Severity Score: First Flare Period	2.8; 3.1; 2.9; 2.9; 3.1; 3.6	—
SECONDARY Patient/Observer Global Impression of Severity Score: First Flare Free Period	2.6; 2.5; 2.7; 2.3; 2.6; 2.3	—
SECONDARY Patient/Observer Global Impression of Change Score: OL Run-in Period	2.8; 2.7; 2.6; 2.6; 2.6; 2.6	—
SECONDARY Patient/Observer Global Impression of Change Score: DB Period	1.8; 1.8; 1.9; 1.8; 3.7; 2.0	—
SECONDARY Patient/Observer Global Impression of Change Score: First Flare Period	3.8; 3.1; 2.7; 2.9; 2.4; 3.2	—
SECONDARY Patient/Observer Global Impression of Change Score: First Flare Free Period	1.8; 1.8; 2.0; 1.8; 2.1; 1.9	—
SECONDARY Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period	7.4; 7.6; 7.6; 7.9; 7.8; 0.4	—
SECONDARY Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period	8.3; 7.5; 8.9; 8.1; 6.9; 8.1	—
SECONDARY Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period	7.3; 7.6; 8.2; 7.3; 8.3; 6.9	—
SECONDARY Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period	8.3; 7.5; 9.0; 8.1; 8.5; 7.9	—
SECONDARY 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	0.9; 0.9; 0.9; 0.9; 0.9	—
SECONDARY 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	0.9; 0.9; 0.9; 0.9; 0.9	—
SECONDARY EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: OL Run-in Period	0.8; 0.9; 0.9; 0.9; 0.9	—
SECONDARY EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Participants >= 18 Years of Age: OL Run-in Period	81.2; 82.2; 82.0; 84.0; 84.2	—
SECONDARY EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age : OL-Run-in Period	85.6; 87.4; 87.5; 87.9; 88.0	—
SECONDARY EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: OL Run-in Period	86.0; 87.6; 90.0; 90.4; 90.8	—
SECONDARY EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period	0.9; 0.9; 0.9; 0.9; 0.9; 0.9	—
SECONDARY EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period	0.9; 0.9; 1.0; 1.0; 0.9; 1.0	—
SECONDARY EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period	1.0; 0.9; 0.9; 0.9; 0.8; 0.9	—
SECONDARY EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period	88.3; 85.2; 89.9; 86.8; 81.9; 90.7	—
SECONDARY EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period	86.8; 91.1; 88.3; 91.6; 84.7; 89.6	—
SECONDARY EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period	93.8; 94.3; 94.6; 96.3; 89.4; 93.0	—
SECONDARY EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period	0.9; 0.9; 1.0; 0.8; 1.0; 0.8	—
SECONDARY EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period	0.9; 0.8; 0.9; 0.9; 0.9; 0.9	—
SECONDARY EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period	0.8; 0.8; 0.9; 0.9; 0.9; 0.8	—
SECONDARY EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period	84.1; 82.8; 87.9; 81.1; 88.6; 88.2	—
SECONDARY EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period	86.5; 88.7; 91.5; 82.3; 85.3; 87.0	—
SECONDARY EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period	84.7; 91.0; 90.3; 91.3; 93.8; 93.0	—
SECONDARY EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period	0.9; 0.9; 0.9; 0.9; 0.9; 0.9	—
SECONDARY EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period	0.9; 0.9; 1.0; 1.0; 1.0; 1.0	—
SECONDARY EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period	1.0; 0.9; 0.9; 0.9; 1.0; 1.0	—
SECONDARY EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period	88.3; 85.2; 89.6; 86.8; 91.3; 88.5	—
SECONDARY EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period	86.8; 91.1; 87.7; 91.6; 88.8; 87.6	—
SECONDARY EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period	93.8; 94.3; 94.6; 96.3; 94.3; 96.0	—
SECONDARY Percent Work Time Missed Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	5.75; 4.72; 5.92; 4.83; 6.96	—
SECONDARY Percent Impairment While Working Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	32.66; 17.02; 15.26; 14.10; 14.37	—
SECONDARY Percent Overall Work Impairment Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period	34.77; 20.10; 19.30; 17.43; 19.36	—
SECONDARY Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	4.14; 5.26; 3.94; 4.71; 4.55	—
SECONDARY Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	26.46; 17.55; 15.37; 13.31; 12.69	—
SECONDARY Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	28.20; 20.27; 18.13; 17.01; 16.20	—
SECONDARY Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period	28.21; 15.83; 14.54; 13.81; 13.55	—
SECONDARY Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	4.77; 5.07; 5.67; 5.54; 2.80; 5.48	—
SECONDARY Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	9.71; 10.26; 4.55; 10.56; 15.22; 6.15	—
SECONDARY Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	14.04; 14.29; 10.20; 15.53; 15.80; 11.46	—
SECONDARY Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	0.04; 2.22; 0.89; 1.14; 5.96; 0.00	—
SECONDARY Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	8.62; 7.88; 5.83; 6.36; 29.33; 4.17	—
SECONDARY Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	8.64; 10.10; 6.37; 7.50; 30.69; 4.17	—
SECONDARY Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period	8.99; 10.90; 10.31; 8.24; 15.88; 8.61	—
SECONDARY Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	4.77; 5.07; 5.76; 5.54; 7.50; 3.64	—
SECONDARY Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	9.71; 10.26; 5.00; 10.56; 4.44; 6.43	—
SECONDARY Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	14.04; 14.29; 10.74; 15.53; 11.77; 10.06	—
SECONDARY Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	0.04; 2.22; 0.97; 1.14; 0.00; 1.62	—
SECONDARY Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	8.62; 7.88; 6.36; 6.36; 1.43; 5.79	—
SECONDARY Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	8.64; 10.10; 6.95; 7.50; 1.43; 7.40	—
SECONDARY Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period	8.99; 10.90; 11.00; 8.24; 10.00; 7.27	—
SECONDARY Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	5.46; 6.99; 1.49; 0.00; 2.36; 0.00	—
SECONDARY Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	11.05; 16.67; 12.00; 10.00; 8.00; 15.00	—
SECONDARY Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	16.21; 20.32; 13.40; 10.00; 10.36; 15.00	—
SECONDARY Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	3.98; 11.53; 0.00; 6.82; 0.00; 8.33	—
SECONDARY Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	13.85; 24.67; 16.67; 25.00; 30.00; 30.00	—
SECONDARY Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	17.49; 25.60; 16.67; 30.21; 30.00; 34.17	—
SECONDARY Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period	14.88; 17.27; 15.24; 19.17; 13.85; 26.00	—
SECONDARY Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period	5.3; 5.3; 5.3; 5.4; 5.4; 3.2	—
SECONDARY Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period	4.5; 4.5; 3.6; 4.5; 3.8; 4.6	—
SECONDARY Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period	3.7; 4.9; 4.3; 5.8; 4.3; 8.0	—
SECONDARY Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period	4.5; 4.5; 3.8; 4.1; 3.9; 4.3	—

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04040192) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.