RosaceaPhase 2NCT01735201

AGN-199201 for the Treatment of Erythema With Rosacea

A Phase 2 study testing AGN-199201 Dose A, AGN-199201 Dose B and AGN-199201 Dose C in people with Rosacea and Erythema, run by Allergan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the safety and efficacy of 3 doses of AGN-199201 once and twice daily compared to vehicle for the treatment of moderate to severe facial erythema associated with rosacea. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rosacea, Erythema
What is being tested?: AGN-199201 Dose A, AGN-199201 Dose B and AGN-199201 Dose C
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 357 participants
Where: 1 siteUnited States
Study dates: Dec 2012to Jun 2013
Phase: Phase 2
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

Redness of the skin caused by rosacea

Who cannot join

≥3 inflammatory lesions
Laser light-source or other energy based therapy in the last 6 months
Any prescription or over the counter product for the treatment of acne or rosacea in the last 14 days

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Austin, Texas

Other trials in United States

About this study

This study will evaluate the safety and efficacy of 3 doses of AGN-199201 once and twice daily compared to vehicle for the treatment of moderate to severe facial erythema associated with rosacea.

Conditions: Rosacea, Erythema
Being tested: AGN-199201 Dose A, AGN-199201 Dose B, AGN-199201 Dose C, AGN-199201 Vehicle
Medical subject headings: Rosacea, Erythema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AGN-199201 Dose ADrug
AGN-199201 Dose A applied once or twice daily to the face for 28 days.
AGN-199201 Dose BDrug
AGN-199201 Dose B applied once or twice daily to the face for 28 days.
AGN-199201 Dose CDrug
AGN-199201 Dose C applied once or twice daily to the face for 28 days.
AGN-199201 VehicleDrug
AGN-199201 Vehicle applied once or twice daily to the face for 28 days.

Study groups in NCT01735201
Study group	Role	What they receive
AGN-199201 Dose A Once Daily	Experimental	AGN-199201 Dose A applied once daily to the face for 28 days. Receives: Drug: AGN-199201 Dose A
AGN-199201 Dose B Once Daily	Experimental	AGN-199201 Dose B applied once daily to the face for 28 days. Receives: Drug: AGN-199201 Dose B
AGN-199201 Dose C Once Daily	Experimental	AGN-199201 Dose C applied once daily to the face for 28 days. Receives: Drug: AGN-199201 Dose C
AGN-199201 Vehicle Once Daily	Placebo comparator	AGN-199201 Vehicle applied once daily to the face for 28 days. Receives: Drug: AGN-199201 Vehicle
AGN-199201 Dose A Twice Daily	Experimental	AGN-199201 Dose A applied twice daily to the face for 28 days. Receives: Drug: AGN-199201 Dose A
AGN-199201 Dose B Twice Daily	Experimental	AGN-199201 Dose B applied twice daily to the face for 28 days. Receives: Drug: AGN-199201 Dose B
AGN-199201 Dose C Twice Daily	Experimental	AGN-199201 Dose C applied twice daily to the face for 28 days. Receives: Drug: AGN-199201 Dose C
AGN-199201 Vehicle Twice Daily	Placebo comparator	AGN-199201 Vehicle applied twice daily to the face for 28 days. Receives: Drug: AGN-199201 Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA)
Percentage of participants 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 were assessed on Day 28 hours 2 to 12. 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.
Measured: Baseline, Day 28-hours 2 to 12

Secondary outcomes (2)

Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28
Percentage of participants 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 were assessed at 0.5 hour post-dose on Day 28. 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.
Measured: Baseline, Day 28-hour 0.5
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28
Percentage of participants 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 were assessed at 1 hour post-dose on Day 28. 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.
Measured: Baseline, Day 28-hour 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012Jun 2013

First posted28 Nov 2012 (estimated)
Study startDec 2012
Primary completionMay 2013
Study completionJun 2013

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 RosaceaStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 357 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01735201
Sponsor's protocol ID: 199201-002
Status last verified: Nov 2019
First submitted: 26 Nov 2012
Last updated: 18 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rosacea trials

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: AGN-199201 for the Treatment of Erythema With Rosacea
ClinicalTrials.gov ID: NCT01735201
Acronym / sponsor ID: 199201-002
Conditions: Rosacea, Erythema
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 357 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: May 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 28 Nov 2012 (estimated)
Results: Posted 30 May 2014

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 3 doses of AGN-199201 once and twice daily compared to vehicle for the treatment of moderate to severe facial erythema associated with rosacea.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
AGN-199201 Dose A Once Daily	Experimental	Drug: AGN-199201 Dose AAGN-199201 Dose A applied once daily to the face for 28 days.
AGN-199201 Dose B Once Daily	Experimental	Drug: AGN-199201 Dose BAGN-199201 Dose B applied once daily to the face for 28 days.
AGN-199201 Dose C Once Daily	Experimental	Drug: AGN-199201 Dose CAGN-199201 Dose C applied once daily to the face for 28 days.
AGN-199201 Vehicle Once Daily	Placebo comparator	Drug: AGN-199201 VehicleAGN-199201 Vehicle applied once daily to the face for 28 days.
AGN-199201 Dose A Twice Daily	Experimental	Drug: AGN-199201 Dose AAGN-199201 Dose A applied twice daily to the face for 28 days.
AGN-199201 Dose B Twice Daily	Experimental	Drug: AGN-199201 Dose BAGN-199201 Dose B applied twice daily to the face for 28 days.
AGN-199201 Dose C Twice Daily	Experimental	Drug: AGN-199201 Dose CAGN-199201 Dose C applied twice daily to the face for 28 days.
AGN-199201 Vehicle Twice Daily	Placebo comparator	Drug: AGN-199201 VehicleAGN-199201 Vehicle applied twice daily to the face for 28 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)

Redness of the skin caused by rosacea

Key exclusion criteria (3 listed)

≥3 inflammatory lesions
Laser light-source or other energy based therapy in the last 6 months
Any prescription or over the counter product for the treatment of acne or rosacea in the last 14 days

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-199201 Dose AAGN-199201 Dose A applied once or twice daily to the face for 28 days.	Drug	AGN-199201 Dose A Once Daily, AGN-199201 Dose A Twice Daily
AGN-199201 Dose BAGN-199201 Dose B applied once or twice daily to the face for 28 days.	Drug	AGN-199201 Dose B Once Daily, AGN-199201 Dose B Twice Daily
AGN-199201 Dose CAGN-199201 Dose C applied once or twice daily to the face for 28 days.	Drug	AGN-199201 Dose C Once Daily, AGN-199201 Dose C Twice Daily
AGN-199201 VehicleAGN-199201 Vehicle applied once or twice daily to the face for 28 days.	Drug	AGN-199201 Vehicle Once Daily, AGN-199201 Vehicle Twice Daily

Primary outcome

Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA)
Time frame: Baseline, Day 28-hours 2 to 12
Percentage of participants 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 were assessed on Day 28 hours 2 to 12. 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.

2 secondary outcomes

Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28
Time frame: Baseline, Day 28-hour 0.5
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28
Time frame: Baseline, Day 28-hour 1

Results and safety

Results posted to the registry on 30 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AGN-199201 Dose A Once Daily	45	42
AGN-199201 Dose B Once Daily	44	43
AGN-199201 Dose C Once Daily	44	44
AGN-199201 Vehicle Once Daily	44	42
AGN-199201 Dose A Twice Daily	45	44
AGN-199201 Dose B Twice Daily	45	40
AGN-199201 Dose C Twice Daily	45	42
AGN-199201 Vehicle Twice Daily	44	42

Primary outcome: Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA)

Time frame: Baseline, Day 28-hours 2 to 12. Number. Unit: Percentage of participants

Measure	AGN-199201 Dose A Once Daily n = 45	AGN-199201 Dose B Once Daily n = 44	AGN-199201 Dose C Once Daily n = 44	AGN-199201 Vehicle Once Daily n = 44	AGN-199201 Dose A Twice Daily n = 45	AGN-199201 Dose B Twice Daily n = 45	AGN-199201 Dose C Twice Daily n = 45	AGN-199201 Vehicle Twice Daily n = 44
Hour 2	13.3	20.5	22.7	6.8	8.9	17.8	15.6	6.8
Hour 4	17.8	31.8	27.3	4.5	11.1	20.0	22.2	6.8
Hour 6	17.8	22.7	13.6	4.5	11.1	13.3	24.4	4.5
Hour 8	15.6	20.5	20.5	4.5	8.9	20.0	20.0	2.3
Hour 10	17.8	20.5	13.6	4.5	13.3	15.6	26.7	2.3
Hour 12	13.3	13.6	13.6	2.3	13.3	11.1	15.6	4.5

Population analysed: Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AGN-199201 Dose A Once Daily	0 of 45 (0%)	5 of 45 (11.1%)	Not reported
AGN-199201 Dose B Once Daily	1 of 44 (2.3%)	5 of 44 (11.4%)	Not reported
AGN-199201 Dose C Once Daily	0 of 44 (0%)	1 of 44 (2.3%)	Not reported
AGN-199201 Vehicle Once Daily	1 of 44 (2.3%)	1 of 44 (2.3%)	Not reported
AGN-199201 Dose A Twice Daily	0 of 45 (0%)	2 of 45 (4.4%)	Not reported
AGN-199201 Dose B Twice Daily	1 of 45 (2.2%)	6 of 45 (13.3%)	Not reported
AGN-199201 Dose C Twice Daily	0 of 45 (0%)	7 of 45 (15.6%)	Not reported
AGN-199201 Vehicle Twice Daily	0 of 44 (0%)	6 of 44 (13.6%)	Not reported

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 2 study testing AGN-199201 Dose A, AGN-199201 Dose B and AGN-199201 Dose C in people with Rosacea and Erythema, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 30 May 2014). 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 Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) (time frame: Baseline, Day 28-hours 2 to 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01735201.

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.