Phase 3
Completed N=764
Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 2 Years and Older) With Atopic Dermatitis
Dermatitis, Atopic
Source: ClinicalTrials.gov NCT02118792 ↗
Enrolled (actual)
764
Serious AEs
0.4%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Participants Who Achieved Success in Investigator's Static Global Assessment (ISGA) Score at Day 29 — 31.4; 18.0 percentage of participants — p=<0.001
◆ Published Evidence
Emerging
19citations · ~5 / year
Subgroup Analysis of Crisaborole for Mild-to-Moderate Atopic Dermatitis in Children Aged 2 to < 18 Years.
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.
Linked Publications (5)
-
Subgroup Analysis of Crisaborole for Mild-to-Moderate Atopic Dermatitis in Children Aged 2 to < 18 Years.
-
Efficacy and Safety Trends with Continuous, Long-Term Crisaborole Use in Patients Aged ≥ 2 Years with Mild-to-Moderate Atopic Dermatitis.
-
Translating the Investigator's Static Global Assessment to the Eczema Area and Severity Index in Studies of Crisaborole for Atopic Dermatitis.
-
Impact of Crisaborole in Treatment-Experienced Patients With Mild-to-Moderate Atopic Dermatitis.
-
Demographics and Baseline Disease Characteristics of Early Responders to Crisaborole for Atopic Dermatitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Success in Investigator's Static Global Assessment (ISGA) Score at Day 29 |
31.4; 18.0 | <0.001 sig |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) |
150; 79; 3; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings at Day 8 |
0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 36 |
0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Laboratory Values |
4; 4 | — |
| PRIMARY Percentage of Participants With Local Tolerability Symptoms at Baseline |
48.7; 56.3; 23.8; 21.9; 19.6; 16.6 | — |
| PRIMARY Percentage of Participants With Local Tolerability Symptoms at Day 8 |
63.8; 73.0; 24.0; 14.8; 9.1; 11.5 | — |
| PRIMARY Percentage of Participants With Local Tolerability Symptoms at Day 15 |
68.0; 70.7; 20.9; 15.5; 7.4; 9.6 | — |
| PRIMARY Percentage of Participants With Local Tolerability Symptoms at Day 22 |
69.0; 71.4; 21.8; 16.7; 6.8; 8.4 | — |
| PRIMARY Percentage of Participants With Local Tolerability Symptoms at Day 29 |
70.4; 73.9; 17.3; 13.5; 10.1; 10.8 | — |
| PRIMARY Percentage of Participants With Local Tolerability Symptoms at Day 36 |
71.1; 77.5; 14.3; 9.9; 9.1; 10.3 | — |
| SECONDARY Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 29 |
48.5; 29.7 | — |
| SECONDARY Time to Achieve Treatment Success Based on Investigator's Static Global Assessment (ISGA) |
NA; NA | — |
| SECONDARY Change From Baseline in Signs of Atopic Dermatitis at Day 29 |
1.7; 1.6; -0.7; -0.3; 1.8; 1.8 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females 2 years and older
- Has a clinical diagnosis of Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka
- Has AD involvement ≥ 5% Treatable %BSA (excluding the scalp)
- Has an ISGA score of Mild (2) or Moderate (3) at Baseline/Day 1
- All female subjects of childbearing potential must use acceptable methods of contraception from the Screening Visit continuously until 30 days after stopping study drug
Exclusion Criteria
- As determined by the study doctor, a medical history that may interfere with study objectives
- Unstable AD or any consistent requirement for high potency topical corticosteroids
- History of use of biologic therapy (including intravenous immunoglobulin)
- Recent or anticipated concomitant use of systemic or topical therapies that might alter the course of AD
- Recent or current participation in another research study
- Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study
- Participation in a previous AN2728 clinical trial
Data sourced from ClinicalTrials.gov (NCT02118792) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.