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Phosphodiesterase-4 (PDE-4) inhibitor

Crisaborole ointment, 2% for Atopic Dermatitis

Phase 4
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline/day 1 at days 8, 15, 22, 29 and 60
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%; crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice daily (BID) in subjects who are at least 2 years of age with mild-moderate AD. A Sub-Study of Optical Coherence Tomography and Biomarkers in Subjects ages 2 to \<18 years old, with Mild to Moderate Atopic Dermatitis, treated with Crisaborole Ointment, 2% or Crisaborole Vehicle Ointment or Hydrocortisone Butyrate 0.1% Cream applied BID will also be conducted at select sites.

Eligible Conditions
  • Atopic Dermatitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline/day 1 at days 8, 15, 22, 29 and 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline/day 1 at days 8, 15, 22, 29 and 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Number of Participants With Clinically Significant Changes in Vital Signs
Number of Participants With Local Tolerability Adverse Events (AEs)
+2 more
Secondary study objectives
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) in Participants Aged 4-15 Years at Day 8, 15, 22 and 29
Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) in Participants Aged 2-17 Years at Day 8, 15, 22 and 29
Change From Baseline in Dermatology Life Quality Index (DLQI) in Participants Greater Than or Equal to (>=) 16 Years at Day 8, 15, 22 and 29
+17 more
Other study objectives
Change in epidermal thickness (Primary Sub-Study Endpoint)
Change in epidermal thickness (Secondary Sub-Study Endpoints)
Change in skin biomarkers of Atopic Dermatitis (Secondary Sub-Study Endpoints)
+2 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Crisaborole ointment, 2%Experimental Treatment1 Intervention
This treatment arm will be administered both in Cohort 1 and Cohort 2.
Group II: Pimecrolimus cream, 1%Active Control1 Intervention
This treatment arm will be administered in Cohort 2 only.
Group III: Hydrocortisone butyrate cream, 0.1%Active Control1 Intervention
This treatment arm will be administered in Cohort 1 only.
Group IV: Crisaborole VehiclePlacebo Group1 Intervention
This treatment arm will be administered both in Cohort 1 and Cohort 2.

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,665 Previous Clinical Trials
17,866,953 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,550 Previous Clinical Trials
14,908,109 Total Patients Enrolled
~31 spots leftby Dec 2025
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