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Anti-inflammatory

AN2728 Topical Ointment, 2% for Atopic Dermatitis

Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up aes: baseline (day 1) up to day 29, saes: baseline (day 1) up to day 36
Awards & highlights
Pivotal Trial
Approved for 5 Other Conditions
All Individual Drugs Already Approved

Summary

The purpose of this study is to investigate the safety and efficacy of AN2728 Topical Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic dermatitis.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~aes: baseline (day 1) up to day 29, saes: baseline (day 1) up to day 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and aes: baseline (day 1) up to day 29, saes: baseline (day 1) up to day 36 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 Change From Baseline in Laboratory Values at Day 29
Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 29
Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
+1 more
Secondary study objectives
Change From Baseline in Signs of Atopic Dermatitis (AD) at Day 29
Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 29
Time to Achieve Treatment Success Based on Investigator's Static Global Assessment (ISGA)
Other study objectives
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Day 29
Time to Improvement in Pruritus

Side effects data

From 2015 Phase 3 trial • 763 Patients • NCT02118766
24%
Burning/Stinging: Mild
18%
Burning/Stinging: Moderate
8%
Burning/Stinging: Severe
6%
Application site pain
3%
Upper respiratory tract infection
3%
Pyrexia
2%
Vomiting
2%
Nasopharyngitis
2%
Nasal congestion
1%
Nausea
1%
Diarrhoea
1%
Pharyngitis
1%
Bronchitis
1%
Sinusitis
1%
Laceration
1%
Headache
1%
Oropharyngeal pain
1%
Dermatitis atopic
1%
Eczema
1%
Eczema infected
1%
Impetigo
1%
Application site pruritus
1%
Conjunctivitis
1%
Otitis media
1%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Crisaborole (AN2728) Ointment, 2 Percent
Crisaborole (AN2728) Ointment Vehicle

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AN2728 Topical Ointment, 2%Experimental Treatment1 Intervention
AN2728 Topical Ointment, 2%, applied twice daily for up to 28 days
Group II: Matching vehicle controlPlacebo Group1 Intervention
Matching vehicle control, applied twice daily for up to 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Crisaborole
FDA approved

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,655 Previous Clinical Trials
17,745,495 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,542 Previous Clinical Trials
14,916,671 Total Patients Enrolled
~65 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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