Trial · NCT02118792
Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 2 Years and Older) With Atopic Dermatitis
NCT02118792, Phase 3, Completed, Pfizer; results first posted 2017-03-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 2 Years and Older) With Atopic Dermatitis. Trials, record NCT02118792. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02118792
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 2 Years and Older) With Atopic Dermatitis
- NCT number
- NCT02118792
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 764 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Dermatitis, Atopic
- Interventions
- AN2728 Topical Ointment, 2%, Matching vehicle control
- First posted
- 2014-04-21
- Last updated
- 2017-03-06
- Results first posted
- 2017-03-06
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Success in Investigator's Static Global Assessment (ISGA) Score at Day 29 | Day 29 | ISGA assessed the severity of AD (except scalp) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual hypo/hyper pigmentation, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Treatment success was defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from baseline. |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36 | An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An 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 to the end of study, that were absent before treatment or that worsened relative to pre-treatment state. |
| Primary | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings at Day 8 | Baseline, Day 8 | ECG parameters that were analyzed: PR interval, QRS interval, QT interval and corrected QT interval based on Fridericia's formula (QTcF). Clinical significance of change from baseline in ECG findings was determined by investigator. |
| Primary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 36 | Baseline (Day 1), Day 36 | Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, pulse, respiratory rate and body temperature. Vital sign measurements were performed with the participant in the seated or supine position and after the participant had been calmly sitting or lying face up for a minimum of 5 minutes. Clinical significance of change from baseline value was determined by investigator. |
| Primary | Number of Participants With Clinically Significant Laboratory Values | Baseline up to Day 36 | Laboratory values included: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Bilirubin, Blood Urea Nitrogen, Glucose, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets, Basophils, Eosinophils, Erythrocytes, Potassium, Protein, Sodium. Clinically significant laboratory abnormalities were defined as abnormal laboratory test values that have clinical manifestations or require medical intervention, as per investigator's discretion. |
| Primary | Percentage of Participants With Local Tolerability Symptoms at Baseline | Baseline (Day 1) | Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale ranging from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicated more severe symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported. |
| Primary | Percentage of Participants With Local Tolerability Symptoms at Day 8 | Day 8 | Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale ranging from 0 to 3, where 0= none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicated more severe symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported. |
| Primary | Percentage of Participants With Local Tolerability Symptoms at Day 15 | Day 15 | Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale ranging from 0 to 3, where 0= none (no stinging/burning), 1= mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicated more severe symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported. |
| Primary | Percentage of Participants With Local Tolerability Symptoms at Day 22 | Day 22 | Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale which ranges from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicate high severity of symptoms. In this outcome, percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported. |
| Primary | Percentage of Participants With Local Tolerability Symptoms at Day 29 | Day 29 | Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale which ranges from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicate high severity of symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved Success in Investigator's Static Global Assessment (ISGA) Score at Day 29 | Day 29 | ITT population included all participants who were randomized and received study drug. | percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36 | Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. | participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings at Day 8 | Baseline, Day 8 | Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. | participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 36 | Baseline (Day 1), Day 36 | Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. | participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Significant Laboratory Values | Baseline up to Day 36 | Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. | participants | NUMBER |
| PRIMARY | Percentage of Participants With Local Tolerability Symptoms at Baseline | Baseline (Day 1) | Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 29 | Day 29 | ITT population included all participants who were randomized and received study drug. | percentage of participants | NUMBER |
| SECONDARY | Time to Achieve Treatment Success Based on Investigator's Static Global Assessment (ISGA) | Baseline up to Day 29 | ITT population included all participants who were randomized and received study drug. | days | MEDIAN |
| SECONDARY | Change From Baseline in Signs of Atopic Dermatitis at Day 29 | Baseline, Day 29 | ITT population included all participants who were randomized and received study drug. Here, 'n' signifies those participants who were evaluable at specific time point for each arm. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Time to Improvement in Pruritus | Baseline (Day 1) up to Day 29 | ITT population included all participants who were randomized and received study drug. Here, N'' signifies those participants who were evaluable for this outcome measure. | days | MEDIAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group98
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Success in Investigator's Static Global Assessment (ISGA) Score at Day 29 | AN2728 Ointment, 2 Percent (%) | 31.4 | percentage of participants | ||
| Percentage of Participants Who Achieved Success in Investigator's Static Global Assessment (ISGA) Score at Day 29 | AN2728 Ointment, Vehicle | 18.0 | percentage of participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | AN2728 Ointment, 2 Percent (%) | AEs | 150 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | AN2728 Ointment, Vehicle | AEs | 79 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | AN2728 Ointment, 2 Percent (%) | SAEs | 3 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | AN2728 Ointment, Vehicle | SAEs | 0 | participants | |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings at Day 8 | AN2728 Ointment, 2 Percent (%) | 0 | participants | ||
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings at Day 8 | AN2728 Ointment, Vehicle | 0 | participants | ||
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 36 | AN2728 Ointment, 2 Percent (%) | 0 | participants | ||
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 36 | AN2728 Ointment, Vehicle | 0 | participants |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AN2728 Ointment, 2 Percent (%) | 514 | |
| Overall Study | STARTED | AN2728 Ointment, Vehicle | 250 | |
| Overall Study | Treated | AN2728 Ointment, 2 Percent (%) | 513 | |
| Overall Study | Treated | AN2728 Ointment, Vehicle | 250 | |
| Overall Study | COMPLETED | AN2728 Ointment, 2 Percent (%) | 483 | |
| Overall Study | COMPLETED | AN2728 Ointment, Vehicle | 213 | |
| Overall Study | NOT COMPLETED | AN2728 Ointment, 2 Percent (%) | 31 | |
| Overall Study | NOT COMPLETED | AN2728 Ointment, Vehicle | 37 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | AN2728 Topical Ointment, 2 Percent (%) | 6 | 510 | |
| other | Diarrhoea | Gastrointestinal disorders | AN2728 Topical Ointment, Vehicle | 2 | 247 | |
| other | Vomiting | Gastrointestinal disorders | AN2728 Topical Ointment, 2 Percent (%) | 7 | 510 | |
| other | Vomiting | Gastrointestinal disorders | AN2728 Topical Ointment, Vehicle | 2 | 247 | |
| other | Application site pain | General disorders | AN2728 Topical Ointment, 2 Percent (%) | 14 | 510 | |
| other | Application site pain | General disorders | AN2728 Topical Ointment, Vehicle | 3 | 247 | |
| other | Application site pruritus | General disorders | AN2728 Topical Ointment, 2 Percent (%) | 1 | 510 | |
| other | Application site pruritus | General disorders | AN2728 Topical Ointment, Vehicle | 3 | 247 | |
| other | Application site urticaria | General disorders | AN2728 Topical Ointment, 2 Percent (%) | 0 | 510 | |
| other | Application site urticaria | General disorders | AN2728 Topical Ointment, Vehicle | 3 | 247 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AN2728 Topical Ointment, 2 Percent (%) | ||
| Total, all-cause mortality | AN2728 Topical Ointment, Vehicle | ||
| Total, other adverse events | AN2728 Topical Ointment, 2 Percent (%) | 92 | 510 |
| Total, other adverse events | AN2728 Topical Ointment, Vehicle | 54 | 247 |
| Total, serious adverse events | AN2728 Topical Ointment, 2 Percent (%) | 3 | 510 |
| Total, serious adverse events | AN2728 Topical Ointment, Vehicle | 0 | 247 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AN2728 Ointment, 2 Percent (%) vs AN2728 Ointment, Vehicle: Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 36 | Trial comparisons |
| AN2728 Topical Ointment, 2 Percent (%) vs AN2728 Topical Ointment, Vehicle: Number of Participants With Clinically Significant Laboratory Values | Trial comparisons |
| AN2728 Ointment, 2 Percent (%) vs AN2728 Ointment, Vehicle: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings at Day 8 | Trial comparisons |
| AN2728 Topical Ointment, 2 Percent (%) vs AN2728 Topical Ointment, Vehicle: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02118792
GET https://conductscience.org/api/trials/v1/NCT02118792/results?page=2