ErythemaPhase 3NCT02131636
Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea
A Phase 3 study testing AGN-199201 in people with Erythema and Rosacea, run by Allergan at 1 site in United States.
Trial summary
This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- AGN-199201
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Moderate to severe persistent facial erythema associated with rosacea.
Who cannot join
- Greater than 3 inflammatory lesions on the face
- Current treatment with monoamine oxidase (MAO) inhibitors
- Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogren's syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.
- Being tested
- AGN-199201, Vehicle to AGN-199201
- Medical subject headings
- Erythema, Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN-199201Drug
AGN-199201 applied to the face once daily for 29 days.
Vehicle to AGN-199201Drug
Vehicle to AGN-199201 applied to the face once daily for 29 days.
| Study group | Role | What they receive |
|---|---|---|
| AGN-199201 | Experimental | AGN-199201 applied to the face once daily for 29 days. Receives: Drug: AGN-199201 |
| Vehicle | Placebo comparator | Vehicle to AGN-199201 applied to the face once daily for 29 days. Receives: Drug: Vehicle to AGN-199201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales
The investigator assessed the patient's overall severity of erythema in the treatment area on the 5 point CEA scale (ranging from 0=clear skin with no signs of erythema to 4=severe erythema/fiery redness). The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) on both CEA and SSA from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.
Measured: Baseline, Day 29 (Hours 3, 6, 9, and 12)
Secondary outcomes (5)
Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale
The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.
Measured: Baseline, Day 29 (Hours 3, 6, 9, and 12)
Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)
Rosacea facial redness in the treatment area was measured by DIA. The percent change was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. Baseline was defined as the measurement at predose on Day 1. A negative number change from baseline indicates a decrease in facial redness (improvement), and a positive number change from baseline indicates an increase in facial redness (worsening).
Measured: Baseline, Day 29 (Hours 3, 6, 9, and 12)
Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9
The SA-RFR questionnaire item 9 is completed by patients assessing treatment satisfaction on facial redness. Patients reporting treatment satisfaction as "very satisfied" or "satisfied" are noted. The percentage of patients was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29.
Measured: Day 29 (Hours 3, 6, 9, and 12)
Change From Baseline on the SA-RFR Questionnaire Item #4
The SA-RFR questionnaire item 4 is completed by patients assessing how much their face burned due to facial redness on a 5 point scale (range 0=does not burn at all and 4=burns a lot). Patients were evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. A lower score change from baseline (negative number) indicates a decrease in facial redness (improvement), and a higher score change from baseline (positive number) indicates an increase in facial burning (worsening).
Measured: Baseline, Day 29 (Hours 3, 6, 9, and 12)
Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale
The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 1 grade decrease (improvement) on the SSA from baseline at Day 1 hour 1. Baseline was defined as the measurement at predose on Day 1.
Measured: Baseline, Day 1 (Hour 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ErythemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131636
- Sponsor's protocol ID
- 199201-004
- Status last verified
- Nov 2019
- First submitted
- 5 May 2014
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea
- ClinicalTrials.gov ID
- NCT02131636
- Acronym / sponsor ID
- 199201-004
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 May 2014 (estimated)
- Results
- Posted 10 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AGN-199201 | Experimental | Drug: AGN-199201AGN-199201 applied to the face once daily for 29 days. |
| Vehicle | Placebo comparator | Drug: Vehicle to AGN-199201Vehicle to AGN-199201 applied to the face once daily for 29 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Moderate to severe persistent facial erythema associated with rosacea.
Key exclusion criteria (3 listed)
- Greater than 3 inflammatory lesions on the face
- Current treatment with monoamine oxidase (MAO) inhibitors
- Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogren's syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGN-199201AGN-199201 applied to the face once daily for 29 days. | Drug | AGN-199201 |
| Vehicle to AGN-199201Vehicle to AGN-199201 applied to the face once daily for 29 days. | Drug | Vehicle |
Primary outcome
Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales
Time frame: Baseline, Day 29 (Hours 3, 6, 9, and 12)
The investigator assessed the patient's overall severity of erythema in the treatment area on the 5 point CEA scale (ranging from 0=clear skin with no signs of erythema to 4=severe erythema/fiery redness). The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) on both CEA and SSA from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.
5 secondary outcomes
Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale
Time frame: Baseline, Day 29 (Hours 3, 6, 9, and 12)
Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)
Time frame: Baseline, Day 29 (Hours 3, 6, 9, and 12)
Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9
Time frame: Day 29 (Hours 3, 6, 9, and 12)
Change From Baseline on the SA-RFR Questionnaire Item #4
Time frame: Baseline, Day 29 (Hours 3, 6, 9, and 12)
Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale
Time frame: Baseline, Day 1 (Hour 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AGN-199201 in people with Erythema and Rosacea, run by Allergan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales (time frame: Baseline, Day 29 (Hours 3, 6, 9, and 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.