Trial · NCT02095158
A Long-Term Safety and Efficacy Study AGN-19920 in Patients With Persistent Erythema Associated With Rosacea
NCT02095158, Phase 3, Completed, Allergan; results first posted 2016-09-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Long-Term Safety and Efficacy Study AGN-19920 in Patients With Persistent Erythema Associated With Rosacea. Trials, record NCT02095158. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02095158
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-Term Safety and Efficacy Study AGN-19920 in Patients With Persistent Erythema Associated With Rosacea
- NCT number
- NCT02095158
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 440 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Erythema, Rosacea
- Interventions
- Oxymetazoline HCL Cream 1.0%
- First posted
- 2014-03-24
- Last updated
- 2019-11-18
- Results first posted
- 2016-09-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-Related Adverse Events | 56 Weeks | An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A Treatment-Related Adverse Event is an Adverse Event determined by the investigator to be causally related to the study medication. |
| Secondary | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales | Baseline, Day 1 Hours 3 and 6, Week 4 Predose and Hours 3 and 6, Week 12 Predose, Week 26 Predose and Hours 3 and 6, Week 39 Predose, Week 52 Predose and Hours 3 and 6, Week 54 Predose | The investigator assessed the participant's overall severity of erythema in the treatment area by using the 5-point CEA scale with photonumeric guide where: 0=clear skin with no signs of erythema (best) to 4=severe erythema; fiery redness (worst). A decrease in the score indicates improvement. The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on both CEA and SSA from Baseline was evaluated over the 6-hour evaluation period (hours 3 and 6) post-dose. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-Related Adverse Events | 56 Weeks | Safety population included all participants who received at least 1 dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales | Baseline, Day 1 Hours 3 and 6, Week 4 Predose and Hours 3 and 6, Week 12 Predose, Week 26 Predose and Hours 3 and 6, Week 39 Predose, Week 52 Predose and Hours 3 and 6, Week 54 Predose | Modified-intent-to-treat (mITT) population consisted of all participants who had at least 1 post-baseline CEA and SSA measurement. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment-Related Adverse Events | Oxymetazoline HCL Cream 1.0% | 8.2 | percentage of participants | ||
| Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales | Oxymetazoline HCL Cream 1.0% | Day 1 (Hour 3) | 11.6 | percentage of participants | |
| Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales | Oxymetazoline HCL Cream 1.0% | Day 1 (Hour 6) | 17.8 | percentage of participants | |
| Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales | Oxymetazoline HCL Cream 1.0% | Week 4 (Predose) | 1.2 | percentage of participants | |
| Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales | Oxymetazoline HCL Cream 1.0% | Week 4 (Hour 3) | 19.5 | percentage of participants | |
| Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales | Oxymetazoline HCL Cream 1.0% | Week 4 (Hour 6) | 23.0 | percentage of participants | |
| Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales | Oxymetazoline HCL Cream 1.0% | Week 12 (Predose) | 6.1 | percentage of participants | |
| Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales | Oxymetazoline HCL Cream 1.0% | Week 26 (Predose) | 6.5 | percentage of participants | |
| Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales | Oxymetazoline HCL Cream 1.0% | Week 26 (Hour 3) | 34.7 | percentage of participants | |
| Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales | Oxymetazoline HCL Cream 1.0% | Week 26 (Hour 6) | 38.1 | percentage of participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oxymetazoline HCL Cream 1.0% | 440 | |
| Overall Study | COMPLETED | Oxymetazoline HCL Cream 1.0% | 365 | |
| Overall Study | NOT COMPLETED | Oxymetazoline HCL Cream 1.0% | 75 |
Source ClinicalTrials.gov
Adverse events13
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 |
|---|---|---|---|---|---|---|
| serious | Angina pectoris | Cardiac disorders | Oxymetazoline HCL Cream 1.0% | 1 | 440 | |
| serious | Coronary artery disease | Cardiac disorders | Oxymetazoline HCL Cream 1.0% | 1 | 440 | |
| serious | Chest pain | General disorders | Oxymetazoline HCL Cream 1.0% | 1 | 440 | |
| serious | Cholecystitis | Hepatobiliary disorders | Oxymetazoline HCL Cream 1.0% | 1 | 440 | |
| serious | Appendicitis | Infections and infestations | Oxymetazoline HCL Cream 1.0% | 1 | 440 | |
| serious | Cellulitis | Infections and infestations | Oxymetazoline HCL Cream 1.0% | 1 | 440 | |
| serious | Chronic sinusitis | Infections and infestations | Oxymetazoline HCL Cream 1.0% | 1 | 440 | |
| serious | Sepsis | Infections and infestations | Oxymetazoline HCL Cream 1.0% | 1 | 440 | |
| serious | Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Oxymetazoline HCL Cream 1.0% | 6 | 440 | |
| serious | Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Oxymetazoline HCL Cream 1.0% | 1 | 440 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oxymetazoline HCL Cream 1.0% | ||
| Total, other adverse events | Oxymetazoline HCL Cream 1.0% | 0 | 440 |
| Total, serious adverse events | Oxymetazoline HCL Cream 1.0% | 15 | 440 |
Source ClinicalTrials.gov
Papers0
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/NCT02095158
GET https://conductscience.org/api/trials/v1/NCT02095158/registered