A Long-Term Safety and Efficacy Study AGN-19920 in Patients With Persistent Erythema Associated With Rosacea
Study Details
Study Description
Brief Summary
This study will evaluate the long-term safety and efficacy of oxymetazoline hydrogen chloride (HCL) Cream 1.0% (AGN-199201) in patients with persistent erythema associated with rosacea.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Oxymetazoline HCL Cream 1.0% Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks. |
Drug: Oxymetazoline HCL Cream 1.0%
Oxymetazoline HCL Cream 1.0% applied to the face once daily for 52 weeks.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-Moderate to severe persistent facial erythema associated with rosacea.
Exclusion Criteria:
-
Current treatment with monoamine oxidase (MAO) inhibitors
-
Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogren's syndrome.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Portland | Oregon | United States |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Medical Director, Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 199201-006
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Oxymetazoline HCL Cream 1.0% |
|---|---|
| Arm/Group Description | Oxymetazoline hydrogen chloride (HCL) Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks. |
| Period Title: Overall Study | |
| STARTED | 440 |
| COMPLETED | 365 |
| NOT COMPLETED | 75 |
Baseline Characteristics
| Arm/Group Title | Oxymetazoline HCL Cream 1.0% |
|---|---|
| Arm/Group Description | Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks. |
| Overall Participants | 440 |
| Age, Customized (participants) [Number] | |
| 18 to 64 years |
370
84.1%
|
| ≥ 65 years |
70
15.9%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
335
76.1%
|
| Male |
105
23.9%
|
Outcome Measures
| Title | Percentage of Participants With Treatment-Related Adverse Events |
|---|---|
| Description | 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. |
| Time Frame | 56 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who received at least 1 dose of study medication. |
| Arm/Group Title | Oxymetazoline HCL Cream 1.0% |
|---|---|
| Arm/Group Description | Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks. |
| Measure Participants | 440 |
| Number [percentage of participants] |
8.2
1.9%
|
| Title | 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 |
|---|---|
| Description | 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. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified-intent-to-treat (mITT) population consisted of all participants who had at least 1 post-baseline CEA and SSA measurement. |
| Arm/Group Title | Oxymetazoline HCL Cream 1.0% |
|---|---|
| Arm/Group Description | Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks. |
| Measure Participants | 440 |
| Day 1 (Hour 3) |
11.6
2.6%
|
| Day 1 (Hour 6) |
17.8
4%
|
| Week 4 (Predose) |
1.2
0.3%
|
| Week 4 (Hour 3) |
19.5
4.4%
|
| Week 4 (Hour 6) |
23.0
5.2%
|
| Week 12 (Predose) |
6.1
1.4%
|
| Week 26 (Predose) |
6.5
1.5%
|
| Week 26 (Hour 3) |
34.7
7.9%
|
| Week 26 (Hour 6) |
38.1
8.7%
|
| Week 39 (Predose) |
9.5
2.2%
|
| Week 52 (Predose) |
11.2
2.5%
|
| Week 52 (Hour 3) |
36.7
8.3%
|
| Week 52 (Hour 6) |
43.4
9.9%
|
| Week 54 (Predose) |
12.1
2.8%
|
Adverse Events
| Time Frame | Up to 56 Weeks | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Oxymetazoline HCL Cream 1.0% | |
| Arm/Group Description | Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks. | |
All Cause Mortality |
||
| Oxymetazoline HCL Cream 1.0% | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Oxymetazoline HCL Cream 1.0% | ||
| Affected / at Risk (%) | # Events | |
| Total | 15/440 (3.4%) | |
| Cardiac disorders | ||
| Angina pectoris | 1/440 (0.2%) | |
| Coronary artery disease | 1/440 (0.2%) | |
| General disorders | ||
| Chest pain | 1/440 (0.2%) | |
| Hepatobiliary disorders | ||
| Cholecystitis | 1/440 (0.2%) | |
| Infections and infestations | ||
| Appendicitis | 1/440 (0.2%) | |
| Cellulitis | 1/440 (0.2%) | |
| Chronic sinusitis | 1/440 (0.2%) | |
| Sepsis | 1/440 (0.2%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Basal cell carcinoma | 6/440 (1.4%) | |
| Cholangiocarcinoma | 1/440 (0.2%) | |
| Squamous cell carcinoma | 1/440 (0.2%) | |
| Nervous system disorders | ||
| Parkinson's disease | 1/440 (0.2%) | |
| Renal and urinary disorders | ||
| Acute kidney injury | 1/440 (0.2%) | |
Other (Not Including Serious) Adverse Events |
||
| Oxymetazoline HCL Cream 1.0% | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/440 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Therapeutic Area Head, |
|---|---|
| Organization | Allergan, Inc |
| Phone | 714-246-4500 |
| clinicaltrials@allergan.com |
- 199201-006