Trial · NCT01579084
Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea
NCT01579084, Phase 1, Completed, Allergan; results first posted 2013-11-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea. Trials, record NCT01579084. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01579084
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea
- NCT number
- NCT01579084
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 64 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Rosacea, Erythema
- Interventions
- AGN-199201 Formulation A, AGN-199201 Formulation B, AGN-199201 Formulation C, AGN-199201 Vehicle
- First posted
- 2012-04-17
- Last updated
- 2019-11-18
- Results first posted
- 2013-11-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1 | Baseline, Day 1-hour 6 | The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 1. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness. |
| Primary | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 5 | Baseline, Day 5-hour 6 | The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 5. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness. |
| Secondary | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | Baseline, Day 1-hour 6, Day 5-hour 6 | The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score at Day 1 and Day 5. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. |
| Secondary | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA | Baseline, Day1-hour 6, Day 5-hour 6 | The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 1 and Day 5. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1 | Baseline, Day 1-hour 6 | Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA. | Percentage of responders | NUMBER |
| SECONDARY | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | Baseline, Day 1-hour 6, Day 5-hour 6 | Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA. | Percentage of responders | NUMBER |
| SECONDARY | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA | Baseline, Day1-hour 6, Day 5-hour 6 | Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA. | Percentage of responders | NUMBER |
| PRIMARY | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 5 | Baseline, Day 5-hour 6 | Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA. | Percentage of responders | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1 | AGN-199201 Formulation A | 15.6 | Percentage of responders | ||
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1 | AGN-199201 Formulation B | 21.9 | Percentage of responders | ||
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1 | AGN-199201 Formulation C | 28.1 | Percentage of responders | ||
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1 | AGN-199201 Vehicle | 0.0 | Percentage of responders | ||
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | AGN-199201 Formulation A | Day 1-hour 6 | 34.4 | Percentage of responders | |
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | AGN-199201 Formulation B | Day 1-hour 6 | 34.4 | Percentage of responders | |
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | AGN-199201 Formulation C | Day 1-hour 6 | 40.6 | Percentage of responders | |
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | AGN-199201 Vehicle | Day 1-hour 6 | 0.0 | Percentage of responders | |
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | AGN-199201 Formulation A | Day 5-hour 6 (Facial Sides n=32,31,31,32) | 15.6 | Percentage of responders | |
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | AGN-199201 Formulation B | Day 5-hour 6 (Facial Sides n=32,31,31,32) | 6.5 | Percentage of responders |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AGN-199201 Formulation A and B | 8 | |
| Overall Study | STARTED | AGN-199201 Formulation B and C | 8 | |
| Overall Study | STARTED | AGN-199201 Formulation C and A | 8 | |
| Overall Study | STARTED | AGN-199201 Formulation A and Vehicle | 8 | |
| Overall Study | STARTED | AGN-199201 Formulation B and Vehicle | 8 | |
| Overall Study | STARTED | AGN-199201 Formulation C and Vehicle | 8 | |
| Overall Study | STARTED | AGN-199201 Formulation A | 4 | |
| Overall Study | STARTED | AGN-199201 Formulation B | 4 | |
| Overall Study | STARTED | AGN-199201 Formulation C | 4 | |
| Overall Study | STARTED | AGN-199201 Vehicle | 4 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events340
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 | Eye pruritus | Eye disorders | AGN-199201 Formulation A and B | 0 | 8 | |
| other | Eye pruritus | Eye disorders | AGN-199201 Formulation B and C | 0 | 8 | |
| other | Eye pruritus | Eye disorders | AGN-199201 Formulation C and A | 0 | 8 | |
| other | Eye pruritus | Eye disorders | AGN-199201 Formulation A and Vehicle | 0 | 8 | |
| other | Eye pruritus | Eye disorders | AGN-199201 Formulation B and Vehicle | 1 | 8 | |
| other | Eye pruritus | Eye disorders | AGN-199201 Formulation C and Vehicle | 0 | 8 | |
| other | Eye pruritus | Eye disorders | AGN-199201 Formulation A | 0 | 4 | |
| other | Eye pruritus | Eye disorders | AGN-199201 Formulation B | 0 | 4 | |
| other | Eye pruritus | Eye disorders | AGN-199201 Formulation C | 0 | 4 | |
| other | Eye pruritus | Eye disorders | AGN-199201 Vehicle | 0 | 4 |
1 to 10 of 340Source ClinicalTrials.gov
See all 340 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AGN-199201 Formulation A and B | ||
| Total, all-cause mortality | AGN-199201 Formulation B and C | ||
| Total, all-cause mortality | AGN-199201 Formulation C and A | ||
| Total, all-cause mortality | AGN-199201 Formulation A and Vehicle | ||
| Total, all-cause mortality | AGN-199201 Formulation B and Vehicle | ||
| Total, all-cause mortality | AGN-199201 Formulation C and Vehicle | ||
| Total, all-cause mortality | AGN-199201 Formulation A | ||
| Total, all-cause mortality | AGN-199201 Formulation B | ||
| Total, all-cause mortality | AGN-199201 Formulation C | ||
| Total, all-cause mortality | AGN-199201 Vehicle |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01579084
GET https://conductscience.org/api/trials/v1/NCT01579084/results?page=2