RosaceaPhase 1NCT01579084

Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea

A Phase 1 study testing AGN-199201 Formulation A, AGN-199201 Formulation B and AGN-199201 Formulation 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 tolerability of AGN-199201 for the treatment of 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 Formulation A, AGN-199201 Formulation B and AGN-199201 Formulation C
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteUnited States
Study dates: Apr 2012to Jun 2012
Phase: Phase 1
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

facial erythema associated with rosacea on both sides of the face

Who cannot join

Laser light-source or other energy based therapy in the last 6 months
Excessive hair around the treatment area

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 tolerability of AGN-199201 for the treatment of erythema associated with rosacea.

Conditions: Rosacea, Erythema
Being tested: AGN-199201 Formulation A, AGN-199201 Formulation B, AGN-199201 Formulation 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 Formulation ADrug
AGN-199201 Formulation A applied to the face as per protocol twice daily.
AGN-199201 Formulation BDrug
AGN-199201 Formulation B applied to the face as per protocol twice daily.
AGN-199201 Formulation CDrug
AGN-199201 Formulation C applied to the face as per protocol twice daily.
AGN-199201 VehicleDrug
AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.

Study groups in NCT01579084
Study group	Role	What they receive
AGN-199201 Formulation A and B	Experimental	AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily. Receives: Drug: AGN-199201 Formulation A; Drug: AGN-199201 Formulation B
AGN-199201 Formulation B and C	Experimental	AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily. Receives: Drug: AGN-199201 Formulation B; Drug: AGN-199201 Formulation C
AGN-199201 Formulation C and A	Experimental	AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily. Receives: Drug: AGN-199201 Formulation A; Drug: AGN-199201 Formulation C
AGN-199201 Formulation A and Vehicle	Other	AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily. Receives: Drug: AGN-199201 Formulation A; Drug: AGN-199201 Vehicle
AGN-199201 Formulation B and Vehicle	Other	AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily. Receives: Drug: AGN-199201 Formulation B; Drug: AGN-199201 Vehicle
AGN-199201 Formulation C and Vehicle	Other	AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily. Receives: Drug: AGN-199201 Formulation C; Drug: AGN-199201 Vehicle
AGN-199201 Formulation A	Experimental	AGN-199201 Formulation A applied to both sides of the face twice daily. Receives: Drug: AGN-199201 Formulation A
AGN-199201 Formulation B	Experimental	AGN-199201 Formulation B applied to both sides of the face twice daily. Receives: Drug: AGN-199201 Formulation B
AGN-199201 Formulation C	Experimental	AGN-199201 Formulation C applied to both sides of the face twice daily. Receives: Drug: AGN-199201 Formulation C
AGN-199201 Vehicle	Placebo comparator	AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily. Receives: Drug: AGN-199201 Vehicle

What is being measured

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

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
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.
Measured: Baseline, Day 1-hour 6
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
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.
Measured: Baseline, Day 5-hour 6

Secondary outcomes (2)

Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA
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.
Measured: Baseline, Day 1-hour 6, Day 5-hour 6
Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA
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.
Measured: Baseline, Day1-hour 6, Day 5-hour 6

Timeline

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

Apr 2012Jun 2012

First posted17 Apr 2012 (estimated)
Study startApr 2012
Primary completionJun 2012
Study completionJun 2012

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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01579084
Sponsor's protocol ID: 199201-001
Status last verified: Nov 2019
First submitted: 13 Apr 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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Enrolling by invitation
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RecruitingPhase 2
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Papulopustular Rosacea
Recruiting
Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
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RecruitingObservational study
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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: Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea
ClinicalTrials.gov ID: NCT01579084
Acronym / sponsor ID: 199201-001
Conditions: Rosacea, Erythema
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 17 Apr 2012 (estimated)
Results: Posted 15 Nov 2013

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 tolerability of AGN-199201 for the treatment of erythema associated with rosacea.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 10

Arm	Type	Receives
AGN-199201 Formulation A and B	Experimental	Drug: AGN-199201 Formulation A, Drug: AGN-199201 Formulation BAGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily.
AGN-199201 Formulation B and C	Experimental	Drug: AGN-199201 Formulation B, Drug: AGN-199201 Formulation CAGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily.
AGN-199201 Formulation C and A	Experimental	Drug: AGN-199201 Formulation A, Drug: AGN-199201 Formulation CAGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily.
AGN-199201 Formulation A and Vehicle	Other	Drug: AGN-199201 Formulation A, Drug: AGN-199201 VehicleAGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily.
AGN-199201 Formulation B and Vehicle	Other	Drug: AGN-199201 Formulation B, Drug: AGN-199201 VehicleAGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily.
AGN-199201 Formulation C and Vehicle	Other	Drug: AGN-199201 Formulation C, Drug: AGN-199201 VehicleAGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily.
AGN-199201 Formulation A	Experimental	Drug: AGN-199201 Formulation AAGN-199201 Formulation A applied to both sides of the face twice daily.
AGN-199201 Formulation B	Experimental	Drug: AGN-199201 Formulation BAGN-199201 Formulation B applied to both sides of the face twice daily.
AGN-199201 Formulation C	Experimental	Drug: AGN-199201 Formulation CAGN-199201 Formulation C applied to both sides of the face twice daily.
AGN-199201 Vehicle	Placebo comparator	Drug: AGN-199201 VehicleAGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

facial erythema associated with rosacea on both sides of the face

Key exclusion criteria (2 listed)

Laser light-source or other energy based therapy in the last 6 months
Excessive hair around the treatment area

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 Formulation AAGN-199201 Formulation A applied to the face as per protocol twice daily.	Drug	AGN-199201 Formulation A, AGN-199201 Formulation A and B, AGN-199201 Formulation A and Vehicle, AGN-199201 Formulation C and A
AGN-199201 Formulation BAGN-199201 Formulation B applied to the face as per protocol twice daily.	Drug	AGN-199201 Formulation A and B, AGN-199201 Formulation B, AGN-199201 Formulation B and C, AGN-199201 Formulation B and Vehicle
AGN-199201 Formulation CAGN-199201 Formulation C applied to the face as per protocol twice daily.	Drug	AGN-199201 Formulation B and C, AGN-199201 Formulation C, AGN-199201 Formulation C and A, AGN-199201 Formulation C and Vehicle
AGN-199201 VehicleAGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.	Drug	AGN-199201 Formulation A and Vehicle, AGN-199201 Formulation B and Vehicle, AGN-199201 Formulation C and Vehicle, AGN-199201 Vehicle

Primary outcome

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
Time frame: 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.
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
Time frame: 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.

2 secondary outcomes

Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA
Time frame: Baseline, Day 1-hour 6, Day 5-hour 6
Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA
Time frame: Baseline, Day1-hour 6, Day 5-hour 6

Results and safety

Results posted to the registry on 15 Nov 2013, 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 Formulation A and B	8	8
AGN-199201 Formulation B and C	8	8
AGN-199201 Formulation C and A	8	8
AGN-199201 Formulation A and Vehicle	8	8
AGN-199201 Formulation B and Vehicle	8	8
AGN-199201 Formulation C and Vehicle	8	8
AGN-199201 Formulation A	4	4
AGN-199201 Formulation B	4	4
AGN-199201 Formulation C	4	4
AGN-199201 Vehicle	4	4

Primary outcome: 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

Time frame: Baseline, Day 1-hour 6. Number. Unit: Percentage of responders

Measure	AGN-199201 Formulation A n = 28	AGN-199201 Formulation B n = 28	AGN-199201 Formulation C n = 28	AGN-199201 Vehicle n = 28
Value	15.6	21.9	28.1	0.0

Population analysed: 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.

Primary outcome: 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

Time frame: Baseline, Day 5-hour 6. Number. Unit: Percentage of responders

Measure	AGN-199201 Formulation A n = 28	AGN-199201 Formulation B n = 28	AGN-199201 Formulation C n = 28	AGN-199201 Vehicle n = 28
Value	6.3	6.5	6.5	3.1

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 Formulation A and B	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
AGN-199201 Formulation B and C	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
AGN-199201 Formulation C and A	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
AGN-199201 Formulation A and Vehicle	0 of 8 (0%)	6 of 8 (75%)	Not reported
AGN-199201 Formulation B and Vehicle	0 of 8 (0%)	6 of 8 (75%)	Not reported
AGN-199201 Formulation C and Vehicle	0 of 8 (0%)	4 of 8 (50%)	Not reported
AGN-199201 Formulation A	0 of 4 (0%)	3 of 4 (75%)	Not reported
AGN-199201 Formulation B	0 of 4 (0%)	3 of 4 (75%)	Not reported
AGN-199201 Formulation C	0 of 4 (0%)	3 of 4 (75%)	Not reported
AGN-199201 Vehicle	0 of 4 (0%)	2 of 4 (50%)	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 1 study testing AGN-199201 Formulation A, AGN-199201 Formulation B and AGN-199201 Formulation 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 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 15 Nov 2013). 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 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 (time frame: Baseline, Day 1-hour 6). The study lists 2 primary outcomes in all. 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 NCT01579084.

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.