A Phase 1 interventional study of Crisaborole ointment 2% and Vehicle in Healthy and Atopic Dermatitis, sponsored by Pfizer. Completed at 1 site in Japan. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-01.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
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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 20th largest by enrollment, is one of 2 that started in 2017, is one of 2 in phase 1, and was the 7th 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: 20 Years to 55 Years · all sexes · healthy volunteers too.
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 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 32 is below 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.
This tab as a report to print or save as PDF → With an account.
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 40th largest by enrollment of the 47 interventional ones that give a count, is one of 3 that started in 2017, is one of 13 in phase 1, and was the 11th 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 |
Add it to your calendar (.ics) → With an account.
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:
This tab as a report to print or save as PDF → With an account.
This is a Phase 1 parallel-cohort study of crisaborole ointment 2% to evaluate the skin irritation potential in adult Japanese healthy subjects in Cohort 1, and to evaluate the safety, tolerability and PK in adult Japanese subjects with mild to moderate AD in Cohort 2.
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.
Cohort 1
Cohort 2
Exclusion Criteria:
Cohort 1
Cohort 2
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Crisaborole ointment 2%
Drug: Vehicle
Crisaborole ointment 2%
Vehicle
Cohort 1: Skin Irritation Index
The skin irritation index is a common measure of skin irritation potential (safety criteria) of investigational product and derived using skin irritation scores. Individual skin irritation score ranges from 0-4, where 0 = no reaction, 0.5 = mild erythema, 1 = erythema, 2 = erythema with edema and papula, 3 = erythema with edema, papula and small water blister, 4 = large water blister, higher score indicates more skin irritation. For each investigational product, the skin irritation index was calculated as the sum of the maximum individual skin irritation scores divided by the number of evaluable participants and multiplied by 100, which ranged from 0 to 400; where, lower score indicated less skin irritation and higher score indicated more skin irritation.
Time frame: Day 3 to 4
Cohort 2: Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug 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. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose of study drug (up to Day 36) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious AEs.
Time frame: Baseline up to Day 36
Cohort 2: Number of Participants With Clinically Significant Vital Signs Abnormalities
Vital signs included pulse rate and blood pressure. Clinical significance of vital signs was determined at the investigator's discretion.
Time frame: Baseline up to end of treatment (Day 8)
Cohort 2: Number of Participants With Laboratory Tests Abnormalities
Laboratory tests abnormalities included: hematology (haemoglobin\[Hb\], haematocrit and erythrocytes\<0.8\*lower limit of normal\[LLN\]; erythrocyte mean corpuscular volume, erythrocyte mean corpuscular Hb and erythrocyte mean corpuscular Hb concentration \<0.9\*LLN and \>1.1\*upper limit of normal\[ULN\]; platelets \<0.5\*LLN and \>1.75\*ULN; leukocytes \<0.6\*LLN and \>1.5\*ULN; lymphocytes/leukocytes\[%\], neutrophils/leukocytes\[%\] \<0.8\*LLN and \>1.2\*ULN; basophils/leukocytes\[%\], eosinophils/leukocytes\[%\], monocytes/leukocytes\[% \]\>1.2\*ULN); clinical chemistry(bilirubin\>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase\>3.0\*ULN; protein and albumin\<0.8\*LLN and \>1.2\*ULN; urea nitrogen and creatinine \>1.3\*ULN; urate\>1.2\*ULN; sodium \<0.95\*LLN and \>1.05\*ULN; potassium, chloride and calcium \<0.9\*LLN and \>1.1\*ULN; fasting glucose \<0.6\*LLN and \>1.5\*ULN); and urinalysis (pH \<4.5 and \>8; glucose, ketones, protein, Hb, urobilinogen, bilirubin, nitrite and leukocyte esterase \>=1).
Time frame: Baseline up to end of treatment (Day 8)
Cohort 2: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Criteria for clinically significant ECG abnormalities included: QT interval \>=500 milliseconds (msec); QT interval corrected using the Fridericia's formula (QTcF) \>=450 msec to \<480 msec, \>=480 msec and \>=500 msec; increase from baseline in QTcF interval \>=30 msec to \<60 msec and \>=60 msec.
Time frame: Baseline up to end of treatment (Day 8)
Cohort 1: Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug 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. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose of study drug (up to Day 29) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious AEs.
Time frame: Baseline up to Day 29
Cohort 2: Maximum Observed Plasma Concentration (Cmax) of Crisaborole and Its Identified Main Oxidative Metabolites
AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.
Time frame: Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8
Cohort 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crisaborole and Its Metabolites
AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.
Time frame: Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8
Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Measurable Concentration (AUClast) of Crisaborole and Its Identified Main Oxidative Metabolites
AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.
Time frame: Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8
Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero to the 24 Hours Post-Dose (AUC24) of Crisaborole and Its Identified Main Oxidative Metabolites (AN7602 and AN8323)
AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.
Time frame: Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8
Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Tau (12 Hours Dosing Interval) (AUCtau) of Crisaborole and Its Identified Main Oxidative Metabolites
AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. AUC tau was defined as area under the plasma concentration-time curve from time 0 to time tau, the dosing interval, where tau =12 hours.
Time frame: Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8
Cohort 2: Accumulation Ratio for Cmax (Rac [Cmax]) of Crisaborole and Its Identified Main Oxidative Metabolites
AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. Accumulation ratio for Cmax (Rac, Cmax) was calculated as Cmax on Day 8 divided by Cmax on Day 1. Cmax was the maximum plasma concentration of Crisaborole and its identified main oxidative metabolites.
Time frame: Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and 8
Cohort 2: Accumulation Ratio for AUCtau (Rac [AUCtau]) of Crisaborole and Its Identified Main Oxidative Metabolites
AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 8 divided by AUCtau on Day 1. Dosing interval = 12 hours.
Time frame: Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and 8
| Milestone | Cohort 1: Crisaborole Ointment 2% and Vehicle | Cohort 2: Crisaborole Ointment 2% | Cohort 2: Vehicle |
|---|---|---|---|
| Started | 20 | 10 | 2 |
| Completed | 20 | 10 | 2 |
| Not completed | 0 | 0 | 0 |
The skin irritation index is a common measure of skin irritation potential (safety criteria) of investigational product and derived using skin irritation scores. Individual skin irritation score ranges from 0-4, where 0 = no reaction, 0.5 = mild erythema, 1 = erythema, 2 = erythema with edema and papula, 3 = erythema with edema, papula and small water blister, 4 = large water blister, higher score indicates more skin irritation. For each investigational product, the skin irritation index was calculated as the sum of the maximum individual skin irritation scores divided by the number of evaluable participants and multiplied by 100, which ranged from 0 to 400; where, lower score indicated less skin irritation and higher score indicated more skin irritation.
| scores on a scale | Cohort 1: Crisaborole Ointment 2% and Vehicle |
|---|---|
| Crisaborole ointment 2% | 40.0 |
| Vehicle | 5.0 |
An AE was any untoward medical occurrence in a participant who received study drug 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. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose of study drug (up to Day 36) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious AEs.
| Participants | Cohort 2: Crisaborole Ointment 2% | Cohort 2: Vehicle |
|---|---|---|
| AEs | 9 | 2 |
| SAEs | 0 | 0 |
Vital signs included pulse rate and blood pressure. Clinical significance of vital signs was determined at the investigator's discretion.
| Participants | Cohort 2: Crisaborole Ointment 2% | Cohort 2: Vehicle |
|---|---|---|
| Cohort 2: Number of Participants With Clinically Significant Vital Signs Abnormalities | 0 | 0 |
Laboratory tests abnormalities included: hematology (haemoglobin\[Hb\], haematocrit and erythrocytes\<0.8\*lower limit of normal\[LLN\]; erythrocyte mean corpuscular volume, erythrocyte mean corpuscular Hb and erythrocyte mean corpuscular Hb concentration \<0.9\*LLN and \>1.1\*upper limit of normal\[ULN\]; platelets \<0.5\*LLN and \>1.75\*ULN; leukocytes \<0.6\*LLN and \>1.5\*ULN; lymphocytes/leukocytes\[%\], neutrophils/leukocytes\[%\] \<0.8\*LLN and \>1.2\*ULN; basophils/leukocytes\[%\], eosinophils/leukocytes\[%\], monocytes/leukocytes\[% \]\>1.2\*ULN); clinical chemistry(bilirubin\>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase\>3.0\*ULN; protein and albumin\<0.8\*LLN and \>1.2\*ULN; urea nitrogen and creatinine \>1.3\*ULN; urate\>1.2\*ULN; sodium \<0.95\*LLN and \>1.05\*ULN; potassium, chloride and calcium \<0.9\*LLN and \>1.1\*ULN; fasting glucose \<0.6\*LLN and \>1.5\*ULN); and urinalysis (pH \<4.5 and \>8; glucose, ketones, protein, Hb, urobilinogen, bilirubin, nitrite and leukocyte esterase \>=1).
| Participants | Cohort 2: Crisaborole Ointment 2% | Cohort 2: Vehicle |
|---|---|---|
| Cohort 2: Number of Participants With Laboratory Tests Abnormalities | 7 | 1 |
Criteria for clinically significant ECG abnormalities included: QT interval \>=500 milliseconds (msec); QT interval corrected using the Fridericia's formula (QTcF) \>=450 msec to \<480 msec, \>=480 msec and \>=500 msec; increase from baseline in QTcF interval \>=30 msec to \<60 msec and \>=60 msec.
| Participants | Cohort 2: Crisaborole Ointment 2% | Cohort 2: Vehicle |
|---|---|---|
| Cohort 2: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | 0 | 0 |
An AE was any untoward medical occurrence in a participant who received study drug 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. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose of study drug (up to Day 29) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious AEs.
| Participants | Cohort 1: Crisaborole Ointment 2% and Vehicle |
|---|---|
| AEs | 0 |
| SAEs | 0 |
AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.
| nanograms per milliliter (ng/mL) | Cohort 2: Crisaborole Ointment 2% |
|---|---|
| Crisaborole: Day 1 | 163.7 ± 71 |
| Crisaborole: Day 8 | 164.9 ± 56 |
| AN7602: Day 1 | 94.97 ± 75 |
| AN7602: Day 8 | 68.83 ± 59 |
| AN8323: Day 1 | 3064 ± 97 |
| AN8323: Day 8 | 8080 ± 71 |
AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.
| hours | Cohort 2: Crisaborole Ointment 2% |
|---|---|
| Crisaborole: Day 1 | 3.000 (3.00 to 3.00) |
| Crisaborole: Day 8 | 3.000 (3.00 to 3.00) |
| AN7602: Day 1 | 3.000 (3.00 to 3.00) |
| AN7602: Day 8 | 3.000 (3.00 to 3.00) |
| AN8323: Day 1 | 3.000 (3.00 to 12.0) |
| AN8323: Day 8 | 3.000 (3.00 to 12.0) |
AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.
| hours*nanograms per milliliter(hr*ng/mL) | Cohort 2: Crisaborole Ointment 2% |
|---|---|
| Crisaborole: Day 1 | 1171 ± 60 |
| Crisaborole: Day 8 | 1527 ± 48 |
| AN7602: Day 1 | 601.9 ± 60 |
| AN7602: Day 8 | 565.5 ± 44 |
| AN8323: Day 1 | 57560 ± 84 |
| AN8323: Day 8 | 169100 ± 68 |
AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.
| hr*ng/mL | Cohort 2: Crisaborole Ointment 2% |
|---|---|
| Crisaborole: Day 1 | 1171 ± 60 |
| Crisaborole: Day 8 | 1527 ± 48 |
| AN7602: Day 1 | 601.9 ± 60 |
| AN7602: Day 8 | 565.5 ± 44 |
| AN8323: Day 1 | 57560 ± 84 |
| AN8323: Day 8 | 169100 ± 68 |
AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. AUC tau was defined as area under the plasma concentration-time curve from time 0 to time tau, the dosing interval, where tau =12 hours.
| hr*ng/mL | Cohort 2: Crisaborole Ointment 2% |
|---|---|
| Crisaborole: Day 1 | 928.9 ± 65 |
| Crisaborole: Day 8 | 1123 ± 51 |
| AN7602: Day 1 | 500.4 ± 66 |
| AN7602: Day 8 | 434.9 ± 50 |
| AN8323: Day 1 | 29360 ± 92 |
| AN8323: Day 8 | 90360 ± 68 |
AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. Accumulation ratio for Cmax (Rac, Cmax) was calculated as Cmax on Day 8 divided by Cmax on Day 1. Cmax was the maximum plasma concentration of Crisaborole and its identified main oxidative metabolites.
| ratio | Cohort 2: Crisaborole Ointment 2% |
|---|---|
| Crisaborole | 1.007 ± 32 |
| AN7602 | 0.7247 ± 24 |
| AN8323 | 2.638 ± 52 |
AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 8 divided by AUCtau on Day 1. Dosing interval = 12 hours.
| ratio | Cohort 2: Crisaborole Ointment 2% |
|---|---|
| Crisaborole | 1.209 ± 25 |
| AN7602 | 0.8688 ± 19 |
| AN8323 | 3.080 ± 48 |
Collected over Baseline up to Day 29 for Cohort 1 and Day 36 for Cohort 2. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: Crisaborole Ointment 2% and Vehicle | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Cohort 2: Crisaborole Ointment 2% | 0/10 (0%) | 0/10 (0%) | 9/10 (90%) |
| Cohort 2: Vehicle | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Event | Cohort 1: Crisaborole Ointment 2% and Vehicle | Cohort 2: Crisaborole Ointment 2% | Cohort 2: Vehicle |
|---|---|---|---|
| Application site irritationGeneral disorders | 0/20 | 7/10 | 1/2 |
| Application site coldnessGeneral disorders | 0/20 | 1/10 | 1/2 |
| Application site painGeneral disorders | 0/20 | 4/10 | 1/2 |
| Application site pruritusGeneral disorders | 0/20 | 0/10 | 1/2 |
| NasopharyngitisInfections and infestations | 0/20 | 0/10 | 1/2 |
| Dermatitis atopicSkin and subcutaneous tissue disorders | 0/20 | 0/10 | 1/2 |
| Eyelid oedemaEye disorders | 0/20 | 1/10 | 0/2 |
Safety analysis population included all participants who received at least one dose of study medication.
| Age, Continuous(years) | Cohort 1: Crisaborole Ointment 2% and Vehicle | Cohort 2: Crisaborole Ointment 2% | Cohort 2: Vehicle | Total |
|---|---|---|---|---|
| Mean | 26.2 ± 5.66 | 35.0 ± 11.28 | 23.5 ± 4.95 | 28.8 ± 8.72 |
| Sex: Female, Male(Participants) | Cohort 1: Crisaborole Ointment 2% and Vehicle | Cohort 2: Crisaborole Ointment 2% | Cohort 2: Vehicle | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 20 | 10 | 2 | 32 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1: Crisaborole Ointment 2% and Vehicle | Cohort 2: Crisaborole Ointment 2% | Cohort 2: Vehicle | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 20 | 10 | 2 | 32 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1: Crisaborole Ointment 2% and Vehicle | Cohort 2: Crisaborole Ointment 2% | Cohort 2: Vehicle | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 20 | 10 | 2 | 32 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
Ran from Sep 2017 to primary completion in Nov 2017, 2 months.
Results were first posted in Mar 2019, 1 year 3 months after primary completion.
Of 114 industry-sponsored phase 1 interventional studies under Dermatitis, Atopic, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 20. This study's 2 months is below that.
Counting every sponsor, half of 131 studies reached it within 13 months; a quarter within 5 and three quarters within 20.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Crisaborole