A Phase 4 interventional study of Crisaborole ointment 2% in Atopic Dermatitis, sponsored by Pfizer. Completed at 32 sites in 3 countries. Open to participants aged 3 Months to 23 Months. Per ClinicalTrials.gov, last updated 2019-10-10.
Sponsored by Pfizer · Phase 4, Interventional, and Treatment
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Among 26 studies testing crisaborole in Dermatitis, Atopic — 4 open to participants now, 4 under way, 1 of them phase 3. crisaborole · Dermatitis, Atopic.
Among the 26 studies testing crisaborole in Dermatitis, Atopic, this one is the 9th largest by enrollment, is one of 2 that started in 2018, is one of 10 in phase 4, and was the 8th registered.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
Browse Dermatitis, Atopic studies →4 of the 26 studies testing crisaborole in Dermatitis, Atopic are open now, in 2 countries. Recruiting first, the newest first:
University of California, San Francisco · Sites in United States
Ages 18+
Shalamar Institute of Health Sciences · Sites in Pakistan
Ages 2–18
Hayat Abad Medical Complex, Peshawar · Sites in Pakistan
Ages 2+
Jinnah Postgraduate Medical Centre
Ages 12–50
By country, each count listing its studies:
crisaborole: first FDA approval 2016 (EUCRISA), first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 193 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 94 (49%) stop at 75 or younger; 93 take children under 18; 51 take healthy volunteers.
This study: 3 Months to 23 Months · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 6 · Phase 3 7 · Phase 4 10
First in 2011; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 137 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Median enrollment 69 across the 26 interventional studies. Of the 21 that completed or were terminated, 17 (81%) have results posted.
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13 of 26 have an industry lead sponsor. The 10 most frequent:
Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
58 studies in Dermatitis, Atopic by Pfizer: 11 open now, 13 under way, 4 of them phase 3. Of 43 finished, 34 (79%) have results posted.
Among the 58 studies in Dermatitis, Atopic by Pfizer, this one is the 23rd largest by enrollment of the 47 interventional ones that give a count, is one of 7 that started in 2018, is one of 2 in phase 4, and was the 12th registered.
Pfizer’s Dermatitis, Atopic studies by the year they started, since 2009.
1 of the studies testing crisaborole in Dermatitis, Atopic that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07162896Phase 3Shalamar Institute of Health SciencesCrisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic Dermatitis | 2027-01 |
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Among the 26 studies testing crisaborole in Dermatitis, Atopic, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Pfizer’s 58 in Dermatitis, Atopic:
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This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.
Approximately 125 subjects will be enrolled. Subjects must have mild-to-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.
In addition, a cohort of at least 16 of the 125 subjects will be included in a subgroup for PK assessment. These subjects must have moderate AD and a minimum of 35% treatable %BSA, excluding the scalp, and must complete all PK assessments to be included in the PK analysis. Of these subjects, at least 3 subjects who are less than 9 months of age will be enrolled. Subjects discontinuing for reasons other than treatment emergent adverse event ( TEAE) may be replaced at the discretion of the sponsor to ensure 16 subjects complete the PK assessments. Only selected study sites will participate in the PK assessment.
Scheduled study visits/telephone contacts for all subjects will occur at Screening (up to 28 days prior to Baseline/Day 1), Baseline/Day 1, Day 8, Day 15, Day 22, Day 29 (end of treatment/early termination), Day 36, and Day 57 (end of study).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Aged ≥ 3 months at the screening visit to \< 24 months on baseline/Day 1, diagnosed with AD
Exclusion Criteria:
Subjects with any dermatological condition or disease (including active or potentially recurrent non-AD dermatological conditions that overlap with AD such as Netherton Syndrome)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be dosed for 28 days. A thin layer of ointment will be applied to all areas designated for treatment.
Drug: Crisaborole ointment 2%
Applied BID
Also known as: Eucrisa
Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. 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; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Site reactions are reactions which occurred in participants at the site of application of investigational product.
Time frame: Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)
Number of Participants With Clinically Significant Height Values Meeting Pre-defined Criteria
Height of participants was measured in terms of centimeter (cm). The pre-defined criteria for measuring the height was less than (\<) 55 cm and greater than (\>) 92.5 cm.
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Weight Values Meeting Pre-defined Criteria
Weight of participants was measured in terms of kilogram (kg). The pre-defined criteria of measuring the weight of participants was less than equal to (\<=) 4.5 kg and \>15 kg.
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) of participants was measured in terms of millimeters of mercury (mmHg). The clinically significant pre-defined criteria were, SBP: change of greater than equal to (\>=) 30 mmHg increase from baseline (IFB) and SBP change of \>= 30 mmHg decrease from baseline (DFB); DBP: change of \>=20 mmHg IFB and DBP change of \>=20 mmHg DFB.
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria
Pulse rate of participants was measured in terms of beats per minute (bpm). The pre-defined criteria of measuring the pulse rate of participants was \<90 bpm and \>180 bpm.
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria
Respiratory rate was measured in terms of number of breaths per minute. The pre-defined criteria of measuring the respiratory rate of participants was \< 22 breaths per min and \> 53 breaths per min.
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria
Body temperature of participants was measured in degree Celsius. The normal body temperature value was \>= 39 degree Celsius.
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria
ECG of participants was measured in terms of millisecond (msec). ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Fridericia's formula (QTcF). ECG values meeting pre-defined criteria were 1) PR interval: greater than equal to (\>=) 25 percent (%) increase when baseline greater than (\>)200 milliseconds (msec); or increase \>=50% when baseline less than or equal to (\<=200) msec; 2) QRS interval: \>=25% increase when baseline \>100 msec; \>=50% increase when baseline \<= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) \> 30 msec. IFB stands for increase from baseline.
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
Number of Participants With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria
Criteria: hematology: hemoglobin, hematocrit, erythrocytes \< 0.8\*lower limit of normal (LLN), platelets \<0.5\*LLN \>1.75\*upper limit of normal (ULN), leukocytes \<0.6\* LLN \>1.5\* ULN, lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes \<0.8\* LLN \>1.2\* ULN, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes monocytes monocytes/leukocytes \>1.2\*ULN. Clinical chemistry: bilirubin \>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase \>3.0\*ULN, protein, albumin \<0.8\* LLN \>1.2\* ULN, blood urea nitrogen, creatinine \>1.3\* ULN, sodium \<0.95\*LLN \>1.05\*ULN, potassium, chloride, bicarbonate \<0.9\* LLN \>1.1\* ULN, glucose \<0.6\*LLN \>1.5\*ULN.
Time frame: Baseline (Day 1) up to Day 29 (end of treatment)
| Milestone | Crisaborole Topical Ointment, 2 Percent |
|---|---|
| Started | 137 |
| Completed | 132 |
| Not completed | 5 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Withdrawal by parent/guardian | 2 |
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. 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; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Site reactions are reactions which occurred in participants at the site of application of investigational product.
| Participants | Crisaborole Topical Ointment, 2 Percent |
|---|---|
| AEs | 88 |
| SAEs | 1 |
| Application site Reactions | 15 |
Height of participants was measured in terms of centimeter (cm). The pre-defined criteria for measuring the height was less than (\<) 55 cm and greater than (\>) 92.5 cm.
| Participants | Crisaborole Topical Ointment, 2 Percent |
|---|---|
| < 55 cm | 0 |
| > 92.5 cm | 3 |
Weight of participants was measured in terms of kilogram (kg). The pre-defined criteria of measuring the weight of participants was less than equal to (\<=) 4.5 kg and \>15 kg.
| Participants | Crisaborole Topical Ointment, 2 Percent |
|---|---|
| <= 4.5 kg | 0 |
| > 15 kg | 3 |
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) of participants was measured in terms of millimeters of mercury (mmHg). The clinically significant pre-defined criteria were, SBP: change of greater than equal to (\>=) 30 mmHg increase from baseline (IFB) and SBP change of \>= 30 mmHg decrease from baseline (DFB); DBP: change of \>=20 mmHg IFB and DBP change of \>=20 mmHg DFB.
| Participants | Crisaborole Topical Ointment, 2 Percent |
|---|---|
| SBP:change of>=30 mmHg IFB | 3 |
| SBP:change of>=30 mmHg DFB | 4 |
| DSBP: change of >= 20 mmHg IFB | 8 |
| DSBP: change of >= 20 mmHg DFB | 18 |
Pulse rate of participants was measured in terms of beats per minute (bpm). The pre-defined criteria of measuring the pulse rate of participants was \<90 bpm and \>180 bpm.
| Participants | Crisaborole Topical Ointment, 2 Percent |
|---|---|
| <90 bpm | 12 |
| >180 bpm | 0 |
Respiratory rate was measured in terms of number of breaths per minute. The pre-defined criteria of measuring the respiratory rate of participants was \< 22 breaths per min and \> 53 breaths per min.
| Participants | Crisaborole Topical Ointment, 2 Percent |
|---|---|
| < 22 breaths per minute | 17 |
| > 53 breaths per minute | 4 |
Body temperature of participants was measured in degree Celsius. The normal body temperature value was \>= 39 degree Celsius.
| Participants | Crisaborole Topical Ointment, 2 Percent |
|---|---|
| Number of Participants With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria | 0 |
ECG of participants was measured in terms of millisecond (msec). ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Fridericia's formula (QTcF). ECG values meeting pre-defined criteria were 1) PR interval: greater than equal to (\>=) 25 percent (%) increase when baseline greater than (\>)200 milliseconds (msec); or increase \>=50% when baseline less than or equal to (\<=200) msec; 2) QRS interval: \>=25% increase when baseline \>100 msec; \>=50% increase when baseline \<= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) \> 30 msec. IFB stands for increase from baseline.
| Participants | Crisaborole Topical Ointment, 2 Percent |
|---|---|
| PR Interval: > 200 msec and >=25% IFB | 0 |
| PR Interval: <= 200 msec and >=50% IFB | 1 |
| QRS Duration: >= 100 msec and >= 25% IFB | 0 |
| QRS Duration: < 100 msec and >= 50% IFB | 0 |
| QTcF Interval: >30 msec | 10 |
Criteria: hematology: hemoglobin, hematocrit, erythrocytes \< 0.8\*lower limit of normal (LLN), platelets \<0.5\*LLN \>1.75\*upper limit of normal (ULN), leukocytes \<0.6\* LLN \>1.5\* ULN, lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes \<0.8\* LLN \>1.2\* ULN, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes monocytes monocytes/leukocytes \>1.2\*ULN. Clinical chemistry: bilirubin \>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase \>3.0\*ULN, protein, albumin \<0.8\* LLN \>1.2\* ULN, blood urea nitrogen, creatinine \>1.3\* ULN, sodium \<0.95\*LLN \>1.05\*ULN, potassium, chloride, bicarbonate \<0.9\* LLN \>1.1\* ULN, glucose \<0.6\*LLN \>1.5\*ULN.
| Participants | Crisaborole Topical Ointment, 2 Percent |
|---|---|
| Number of Participants With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria | 105 |
Collected over Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Crisaborole Topical Ointment, 2 Percent | 0/137 (0%) | 1/137 (0.7%) | 41/137 (29.9%) |
| Event | Crisaborole Topical Ointment, 2 Percent |
|---|---|
| Febrile convulsionNervous system disorders | 1/137 |
| Event | Crisaborole Topical Ointment, 2 Percent |
|---|---|
| PyrexiaGeneral disorders | 13/137 |
| DiarrhoeaGastrointestinal disorders | 10/137 |
| Upper respiratory tract infectionInfections and infestations | 10/137 |
| Dermatitis atopicSkin and subcutaneous tissue disorders | 9/137 |
| Dermatitis diaperSkin and subcutaneous tissue disorders | 9/137 |
| CoughRespiratory, thoracic and mediastinal disorders | 7/137 |
Safety analysis set included any participant who received at least 1 dose of investigational product.
| Age, Continuous(months) | Crisaborole Topical Ointment, 2 Percent |
|---|---|
| Mean | 13.6 ± 6.42 |
| Sex: Female, Male(Participants) | Crisaborole Topical Ointment, 2 Percent |
|---|---|
| Female | 49 |
| Male | 88 |
| Ethnicity (NIH/OMB)(Participants) | Crisaborole Topical Ointment, 2 Percent |
|---|---|
| Hispanic or Latino | 16 |
| Not Hispanic or Latino | 118 |
| Unknown or Not Reported | 3 |
| Race (NIH/OMB)(Participants) | Crisaborole Topical Ointment, 2 Percent |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 27 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 11 |
| White | 84 |
| More than one race | 13 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Data sharing details ↗ · www.pfizer.com
Ran from Jan 2018 to primary completion in Apr 2019, 14 months.
Results were first posted in Oct 2019, 5 months after primary completion.
Of 45 phase 4 interventional studies under Dermatitis, Atopic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 41. This study's 14 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Crisaborole