Atopic DermatitisPhase 3NCT04360187
Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis
A Phase 3 study testing Crisaborole Ointment in people with Atopic Dermatitis, run by Pfizer at 39 sites in 3 countries.
Trial summary
This study is a phase 3, randomized, double blind and vehicle study to evaluate the efficacy and safety of Crisaborole ointment, 2% in Chinese and Japanese subjects with mild to moderate atopic dermatitis involving at least 5% treatable BSA. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Crisaborole Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 391 participants
- Where
- 39 sitesin 3 countries
- Study dates
- 27 Jul 2020to 8 Sep 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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) or clinically significant physical examination finding at Screening that in the PI's or designee's opinion may interfere with study objectives.
- Has participated in a previous crisaborole clinical study.
Trial locations and contacts
39 sites in 3 countries.
39 sites in 3 countries
China22 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Peking University People's Hospital
Beijing, 100044
Beijing Children's Hospital, Capital Medical University
Beijing, 100045
The First hospital of Jilin University
Changchun, Jilin, 130021
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
The Second Affiliated Hospital of Army Medical University,PLA
Chongqing, 400037
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Hangzhou Third Hospital
Hangzhou, Zhejiang, 310009
Zhejiang Provincial People's Hospital/Dermatology Department
Hangzhou, Zhejiang, 310014
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310016
Shandong Provincial Institute of Dermatology and Venereology & Shandong Provincial Hospital for Skin
Jinan, Shandong, 250022
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
Children's Hospital of Shanghai
Shanghai, 200062
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
Shenzhen Children's Hospital
Shenzhen, Guangdong, 518026
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, 300120
The first Affiliated hospital of Wenzhou medical University
Wenzhou, Zhejiang, 325000
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Japan16 sites
Mildix Skin Clinic
Adachi-ku, Tokyo, 120-0034
Yoshimura Child Clinic
Akashi, Hyōgo, 674-0068
Motomachi Dermatology Clinic
Asahikawa-shi, Hokkaido, 070-0810
Chitose dermatology and plastic surgery clinic
Chitose Shi, Hokkaido, 066-0021
Hoshikuma Dermatology・Allergy Clinic
Fukuoka, 814-0171
Shirao Clinic of Pediatrics and Pediatric Allergy
Hiroshima, Hiroshima, 734-0023
Noguchi Dermatology Clinic
Kamimashiki-gun, Kumamoto, 861-3101
Iryouhoujinshadan Yamayurikai Tsujino. Kodomo Clinic
Kobe, Hyōgo, 658-0082
Miyata Dermatology Clinic
Matsudo, Chiba, 271-0092
Yoshioka Dermatology Clinic
Neyagawa, Osaka, 572-0838
Takagi Dermatological Clinic
Obihiro, Hokkaido, 080-0013
Kume Clinic
Sakai, Osaka, 593-8324
Yoga Allergy Clinic
Setagaya-ku, Tokyo, 158-0097
Sugamo Kobayashi Derma Clinic
Toshima-Ku, Tokyo, 170-0002
Sugamo Sengoku Dermatology
Toshima-Ku, Tokyo, 170-0002
Nomura Dermatology Clinic
Yokohama, Kanagawa, 221-0825
South Korea1 site
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
About this study
Official title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CRISABOROLE OINTMENT, 2% IN CHINESE AND JAPANESE PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD TO MODERATE ATOPIC DERMATITIS
This study is a phase 3, randomized, double blind and vehicle study to evaluate the efficacy and safety of Crisaborole ointment, 2% in Chinese and Japanese subjects with mild to moderate atopic dermatitis involving at least 5% treatable BSA. Eligible subjects will be randomized in a 2:1 ratio to one of 2 treatment groups (Crisaborole BID, Vehicle BID, respectively).
- Conditions
- Atopic Dermatitis
- Being tested
- Crisaborole Ointment, Crisaborole Placebo Vehicle
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crisaborole OintmentDrug
Crisaborole ointment 2%
Crisaborole Placebo VehicleDrug
Placebo for crisaborole ointment
| Study group | Role | What they receive |
|---|---|---|
| Crisaborole ointment | Experimental | Crisaborole ointment application twice daily for 28 days Receives: Drug: Crisaborole Ointment |
| Crisaborole Placebo Vehicle | Placebo comparator | Vehicle Ointment application twice daily for 28 days Receives: Drug: Crisaborole Placebo Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 29
The EASI quantifies the severity of a participant'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. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Measured: Baseline, Day 29
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An adverse event was considered as a treatment-emergent adverse event (TEAE) if the event started after the first dose of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.
Measured: Baseline up to Day 60
Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Laboratory parameters included: hematology and chemistry. Clinically significant laboratory abnormalities are defined as abnormal values that have clinical manifestations or require medical intervention. Clinically significant laboratory criteria included Hemoglobin <0.8 x lower limit of normal (LLN), Leukocytes >1.5 x upper limit of normal (ULN), Lymphocytes <0.8 x LLN, Lymphocytes/Leukocytes >1.2 x ULN, Neutrophils <0.8 x LLN, Neutrophils >1.2x ULN, Neutrophils/Leukocytes <0.8 x LLN, Basophils/Leukocytes >1.2 x ULN, Eosinophils >1.2 x ULN, Eosinophils/Leukocytes >1.2 x ULN, Monocytes >1.2 x ULN, Monocytes/Leukocytes (%) >1.2 x ULN, Bicarbonate <0.9 x LLN, and Glucose >1.5x ULN.
Measured: Baseline up to Day 29
Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs
Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participants in the seated position, after having sat/lied calmly for at least 5 minutes. Clinically significant vital signs criteria included Diastolic Blood Pressure (DBP) Value <50 mmHg, DBP Change ≥20 mmHg increase, DBP Change ≥20 mmHg decrease, Pulse Rate Value >120 beats per minute (bpm), Systolic Blood Pressure (SBP) Value <90 mmHg, SBP Change ≥30 mmHg increase, SBP Change ≥30mmHg decrease
Measured: Baseline up to Day 29
Secondary outcomes (22)
Percentage of Participants Achieving Improvement in Investigator's Static Global Assessment (ISGA) at Day 29
ISGA assessed the severity of atopic dermatitis (AD) 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). Improvement in ISGA is defined as ISGA score of 0 or 1.
Measured: Baseline, Day 29
Percentage of Participants Achieving Success in ISGA at Day 29
ISGA assessed the severity of AD 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). Success in ISGA is defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2 grade improvement from Baseline.
Measured: Baseline, Day 29
Change From Baseline in Peak Pruritus Numeric Rating Scale (NRS) at Week 4-for Participants ≥12 Years
Participant-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point NRS where 0 is no pruritus and 10 is worst itch imaginable. Change: score at Week 4 minus score at baseline.
Measured: Baseline, Week 4
Percentage of Participants Achieving Success in ISGA Over Time
ISGA assessed the severity of AD 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). Success in ISGA is defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2 grade improvement from Baseline.
Measured: Baseline, Day 8, Day 15, Day 22, Day 29
Percentage of Participants Achieving Improvement in ISGA Over Time
ISGA (Investigator's Static Global Assessment) assessed the severity of AD on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD.
Improvement in ISGA is defined as an ISGA score of Clear (0) or Almost Clear (1) .
Measured: Baseline, Day 8, Day 15, Day 22, Day 29
Percent Change From Baseline in EASI Total Score Over Time
The EASI quantifies the severity of a participant's AD based on both severity of lesion clinical signs and the percent of 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. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Measured: Baseline, Day 8, Day 15, Day 22, Day 29
Change From Baseline in Percent Body Surface Area (%BSA) Over Time
4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp was excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated.
Measured: Baseline, Day 8, Day 15, Day 22, Day 29
Percentage of Participants Achieving EASI-50 Over Time
The EASI quantifies the severity of a participant's AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis.
EASI-50 is defined as EASI score has ≥50% improvement from baseline.
Measured: Baseline, Day 8, Day 15, Day 22, Day 29
Percentage of Participants Achieving EASI-75 Over Time
The EASI quantifies the severity of a participant's AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis.
EASI-75 is defined as EASI score has ≥75% improvement from baseline.
Measured: Baseline, Day 8, Day 15, Day 22, Day 29
Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years
Peak Pruritus NRS is participants-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point NRS where 0 is no pruritus and 10 is worst itch imaginable.
Change: score at observation minus score at baseline.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4
Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years
Patient Reported Itch Severity Scale is a 5-point scale indicating no itchy to very itchy (ranged from 0 to 4, where 0=no itch to 4=worst itch imaginable) for participants ≥6 and <12 years of age.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4
Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years
Observer Reported Itch Severity Scale is an 11-point (ranged from 0 to 10, where 0=no itch to 10=worst itch imaginable) scale and must be completed by the observer (caregivers of participants) for participants <6 years of age.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time
The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. The questionnaire will be completed by all participants aged 16 years and older, based on the age at Screening Visit/time of informed consent/assent. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: Baseline, Day 15, Day 29
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score Over Time
The CDLQI was a 10-item questionnaire that measures the impact of skin disease on children's (aged 4-15 years) quality of life. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: Baseline, Day 15, Day 29
Change From Infants' Dermatitis Quality of Life Index (IDQOL) Total Score Over Time
The IDQOL was completed by observer for participants aged 2-3 years, based on the age at the Screening Visit/time of informed consent/assent. The IDQOL is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score the more quality of life is impaired.
Measured: Baseline, Day 15, Day 29
Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score Over Time
The DFI was completed by all observer for participants aged 2-17 years, based on the age at Screening Visit/time of informed consent/assent. The minimum DFI score is 0; the maximum DFI score is 30. The higher score means worse outcome.
Measured: Baseline, Day 15, Day 29
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Over Time in Participants ≥12 Years
The POEM is a validated 7-item measure used to assess the impact of AD over the past week. The POEM contains 7 symptom based questions with responses rating number of days each symptom is experienced over the past week, from 0 (no days) to 4 (every day), with a maximum score of 28. Higher score means worse outcome.
Measured: Baseline, Day 15, Day 29
Change From Baseline in POEM Over Time in Participants ≥2 Years and <12 Years
The POEM is a validated 7-item measure used to assess the impact of AD over the past week. The POEM contains 7 symptom based questions with responses rating number of days each symptom is experienced over the past week, from 0 (no days) to 4 (every day), with a maximum score of 28. Higher score means worse outcome.
Measured: Baseline, Day 15, Day 29
Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score
The PGIS (for participants 12 years and older) is a single item patient-rated measure of the participant's AD condition severity at a given point in time.
This single item instrument uses a 7-point rating scale, which range from 1 to 7, where 1=Not present to 7=Extremely severe.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4
Patient Global Impression of Change (PGIC) Score
The PGIC (for participants 12 years and older) was used to determine global improvement as assessed by the participant or caregiver. It was used as an anchor to define a responder definition for the peak pruritus scales for 'clinically important responder' and as a sensitivity analysis for defining a 'clinical important difference' on the peak pruritus scales.
This single item instrument is a 7-point rating scale, anchored by (1) 'very much improved' to (7) 'very much worse'.
Measured: Day 8, Day 15, Day 22, Day 29
Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score
The OGIS (for participants ≥2 and <12 years) is a single item observer-rated measure of the participant's AD condition severity at a given point in time.
This single item instrument uses a 7-point rating scale, which ranged from 1 to 7, where 1=Not present to 7=Extremely severe.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4
Observer Reported Global Impression of Change (OGIC) Score
The OGIC (for participants ≥2 and <12 years ) was used to determine global improvement as assessed by the participant or caregiver. It was used as an anchor to define a responder definition for the peak pruritus scales for 'clinically important responder' and as a sensitivity analysis for defining a 'clinical important difference' on the peak pruritus scales.
This single item instrument is a 7-point rating scale, anchored by (1) 'very much improved' to (7) 'very much worse'.
Measured: Day 8, Day 15, Day 22, Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start27 Jul 2020
- Primary completion8 Sep 2021
- Study completion8 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360187
- Sponsor's protocol ID
- C3291032
- Status last verified
- May 2022
- First submitted
- 4 Apr 2020
- Last updated
- 7 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Ma L, Tao X, Liu S, Cheng H, Fang R, Zhao Y, Cha A, Encinas GA, Zhou Y, Deng Y, Zhang J. Efficacy and Safety of Crisaborole Ointment 2% in Chinese Patients Aged >/= 2 Years with Mild to Moderate Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 May;14(5):1229-1243. doi: 10.1007/s13555-024-01156-6. Epub 2024 May 15.
PubMed 38748345
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CRISABOROLE OINTMENT, 2% IN CHINESE AND JAPANESE PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD TO MODERATE ATOPIC DERMATITIS
- ClinicalTrials.gov ID
- NCT04360187
- Acronym / sponsor ID
- C3291032
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Posted 2 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a phase 3, randomized, double blind and vehicle study to evaluate the efficacy and safety of Crisaborole ointment, 2% in Chinese and Japanese subjects with mild to moderate atopic dermatitis involving at least 5% treatable BSA. Eligible subjects will be randomized in a 2:1 ratio to one of 2 treatment groups (Crisaborole BID, Vehicle BID, respectively).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crisaborole ointment | Experimental | Drug: Crisaborole OintmentCrisaborole ointment application twice daily for 28 days |
| Crisaborole Placebo Vehicle | Placebo comparator | Drug: Crisaborole Placebo VehicleVehicle Ointment application twice daily for 28 days |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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) or clinically significant physical examination finding at Screening that in the PI's or designee's opinion may interfere with study objectives.
- Has participated in a previous crisaborole clinical study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crisaborole OintmentCrisaborole ointment 2% | Drug | Crisaborole ointment |
| Crisaborole Placebo VehiclePlacebo for crisaborole ointment | Drug | Crisaborole Placebo Vehicle |
Primary outcome
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 29
Time frame: Baseline, Day 29
The EASI quantifies the severity of a participant'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. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 60
An adverse event was considered as a treatment-emergent adverse event (TEAE) if the event started after the first dose of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.
Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Time frame: Baseline up to Day 29
Laboratory parameters included: hematology and chemistry. Clinically significant laboratory abnormalities are defined as abnormal values that have clinical manifestations or require medical intervention. Clinically significant laboratory criteria included Hemoglobin <0.8 x lower limit of normal (LLN), Leukocytes >1.5 x upper limit of normal (ULN), Lymphocytes <0.8 x LLN, Lymphocytes/Leukocytes >1.2 x ULN, Neutrophils <0.8 x LLN, Neutrophils >1.2x ULN, Neutrophils/Leukocytes <0.8 x LLN, Basophils/Leukocytes >1.2 x ULN, Eosinophils >1.2 x ULN, Eosinophils/Leukocytes >1.2 x ULN, Monocytes >1.2 x ULN, Monocytes/Leukocytes (%) >1.2 x ULN, Bicarbonate <0.9 x LLN, and Glucose >1.5x ULN.
Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs
Time frame: Baseline up to Day 29
Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participants in the seated position, after having sat/lied calmly for at least 5 minutes. Clinically significant vital signs criteria included Diastolic Blood Pressure (DBP) Value <50 mmHg, DBP Change ≥20 mmHg increase, DBP Change ≥20 mmHg decrease, Pulse Rate Value >120 beats per minute (bpm), Systolic Blood Pressure (SBP) Value <90 mmHg, SBP Change ≥30 mmHg increase, SBP Change ≥30mmHg decrease
22 secondary outcomes
Percentage of Participants Achieving Improvement in Investigator's Static Global Assessment (ISGA) at Day 29
Time frame: Baseline, Day 29
Percentage of Participants Achieving Success in ISGA at Day 29
Time frame: Baseline, Day 29
Change From Baseline in Peak Pruritus Numeric Rating Scale (NRS) at Week 4-for Participants ≥12 Years
Time frame: Baseline, Week 4
Percentage of Participants Achieving Success in ISGA Over Time
Time frame: Baseline, Day 8, Day 15, Day 22, Day 29
Percentage of Participants Achieving Improvement in ISGA Over Time
Time frame: Baseline, Day 8, Day 15, Day 22, Day 29
Percent Change From Baseline in EASI Total Score Over Time
Time frame: Baseline, Day 8, Day 15, Day 22, Day 29
Change From Baseline in Percent Body Surface Area (%BSA) Over Time
Time frame: Baseline, Day 8, Day 15, Day 22, Day 29
Percentage of Participants Achieving EASI-50 Over Time
Time frame: Baseline, Day 8, Day 15, Day 22, Day 29
Percentage of Participants Achieving EASI-75 Over Time
Time frame: Baseline, Day 8, Day 15, Day 22, Day 29
Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4
Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4
Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time
Time frame: Baseline, Day 15, Day 29
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score Over Time
Time frame: Baseline, Day 15, Day 29
Change From Infants' Dermatitis Quality of Life Index (IDQOL) Total Score Over Time
Time frame: Baseline, Day 15, Day 29
Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score Over Time
Time frame: Baseline, Day 15, Day 29
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Over Time in Participants ≥12 Years
Time frame: Baseline, Day 15, Day 29
Change From Baseline in POEM Over Time in Participants ≥2 Years and <12 Years
Time frame: Baseline, Day 15, Day 29
Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4
Patient Global Impression of Change (PGIC) Score
Time frame: Day 8, Day 15, Day 22, Day 29
Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4
Observer Reported Global Impression of Change (OGIC) Score
Time frame: Day 8, Day 15, Day 22, Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38748345Ma L, Tao X, Liu S, Cheng H, Fang R, Zhao Y, Cha A, Encinas GA, Zhou Y, Deng Y, Zhang J. Efficacy and Safety of Crisaborole Ointment 2% in Chinese Patients Aged >/= 2 Years with Mild to Moderate Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 May;14(5):1229-1243. doi: 10.1007/s13555-024-01156-6. Epub 2024 May 15.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
39 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Crisaborole Ointment in people with Atopic Dermatitis, run by Pfizer at 39 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in China, Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 29 (time frame: Baseline, Day 29). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04360187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.