ErythemaPhase 3NCT02132117

Safety and Efficacy of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea

A Phase 3 study testing Oxymetazoline HCL Cream 1.0% in people with Erythema and Rosacea, 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 oxymetazoline hydrochloride (HCl) cream 1.0% (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
Conditions the study is for: Erythema, Rosacea
What is being tested?: Oxymetazoline HCL Cream 1.0%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 445 participants
Where: 1 siteUnited States
Study dates: Jun 2014to May 2015
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.

United States1 site

Study site
College Station, Texas

Other trials in United States

About this study

Conditions: Erythema, Rosacea
Being tested: Oxymetazoline HCL Cream 1.0%, Vehicle to Oxymetazoline HCL Cream
Medical subject headings: Erythema, Rosacea

What participants receive

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

Oxymetazoline HCL Cream 1.0%Drug
Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 29 days.
Vehicle to Oxymetazoline HCL CreamDrug
Vehicle to Oxymetazoline HCL Cream (AGN-199201) applied to the face once daily for 29 days.

Study groups in NCT02132117
Study group	Role	What they receive
Oxymetazoline HCL Cream 1.0%	Experimental	Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days. Receives: Drug: Oxymetazoline HCL Cream 1.0%
Vehicle	Placebo comparator	Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days. Receives: Drug: Vehicle to Oxymetazoline HCL Cream

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 Improvement (Decrease) From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment for Rosacea Facial Redness (SSA) 5-point Scales
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 12-hour evaluation period (hours 3, 6, 9, and 12) post-dose on Day 29. Baseline was defined as the measurement at pre-dose on Day 1.
Measured: Baseline, Day 29 (Hours 3, 6, 9 and 12)

Secondary outcomes (5)

Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on SSA at Hours 3, 6, 9 and 12 on Day 29
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 SSA from Baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) post-dose on Day 29.
Measured: Baseline, Day 29 (Hours 3, 6, 9 and 12)
Percent Change From Baseline on Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) at Hours 3, 6, 9 and 12 on Day 29
DIA of photographs was used to assess rosacea facial redness and was defined as percentage of facial area occupied by redness. A higher value in the percentage of facial area occupied by facial redness indicated more redness. A negative/ lower number percent change from Baseline indicates improvement.
Measured: Baseline, Day 29 (Hours 3, 6, 9 and 12)
Percentage of Participants Satisfied or Very Satisfied on Item #9 of Satisfaction Assessment for Rosacea Facial Redness (SAT-RFR) at Hours 3, 6, 9 and 12 on Day 29
Participants assessed their treatment satisfaction by answering Item #9 of the SAT-RFR: "Right now, how satisfied are you with the effect your study medication had on your facial redness?" using a 5-point scale where 0= very dissatisfied, 1=dissatisfied, 2=neither satisfied or dissatisfied, 3=satisfied, or 4=very satisfied. The percentage of participants who answered Satisfied or Very Satisfied is reported.
Measured: Day 29 (Hours 3, 6, 9 and 12)
Change From Baseline on the Symptom Assessment for Rosacea Facial Redness (SA-RFR) Item # 4 at Hours 3, 6, 9 and 12 on Day 29
Participants assessed the burning sensation associated with rosacea facial redness by answering Item #4 of the SA-RFR: "Right now, how much does your face burn because of your facial redness?" using a 5-point scale where 0=less severe to 4=severe. A negative change from Baseline indicates improvement.
Measured: Baseline, Day 29 (Hours 3, 6, 9 and 12)
Percentage of Participants With at Least a 1-Grade Improvement (Decrease) From Baseline on SSA at Hour 1 on Day 1
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.
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.

Jun 2014May 2015

First posted7 May 2014 (estimated)
Study startJun 2014
Primary completionApr 2015
Study completionMay 2015

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: 445 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02132117
Sponsor's protocol ID: 199201-005
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

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 Erythema 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 Efficacy of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea
ClinicalTrials.gov ID: NCT02132117
Acronym / sponsor ID: 199201-005
Conditions: Erythema, Rosacea
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 445 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Apr 2015 (actual)
Study completion: May 2015 (actual)
First posted: 7 May 2014 (estimated)
Results: Posted 2 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Oxymetazoline HCL Cream 1.0%	Experimental	Drug: Oxymetazoline HCL Cream 1.0%Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
Vehicle	Placebo comparator	Drug: Vehicle to Oxymetazoline HCL CreamVehicle to Oxymetazoline HCL Cream 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
Oxymetazoline HCL Cream 1.0%Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 29 days.	Drug	Oxymetazoline HCL Cream 1.0%
Vehicle to Oxymetazoline HCL CreamVehicle to Oxymetazoline HCL Cream (AGN-199201) applied to the face once daily for 29 days.	Drug	Vehicle

Primary outcome

Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment for Rosacea Facial Redness (SSA) 5-point Scales
Time frame: Baseline, Day 29 (Hours 3, 6, 9 and 12)
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 12-hour evaluation period (hours 3, 6, 9, and 12) post-dose on Day 29. Baseline was defined as the measurement at pre-dose on Day 1.

5 secondary outcomes

Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on SSA at Hours 3, 6, 9 and 12 on Day 29
Time frame: Baseline, Day 29 (Hours 3, 6, 9 and 12)
Percent Change From Baseline on Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) at Hours 3, 6, 9 and 12 on Day 29
Time frame: Baseline, Day 29 (Hours 3, 6, 9 and 12)
Percentage of Participants Satisfied or Very Satisfied on Item #9 of Satisfaction Assessment for Rosacea Facial Redness (SAT-RFR) at Hours 3, 6, 9 and 12 on Day 29
Time frame: Day 29 (Hours 3, 6, 9 and 12)
Change From Baseline on the Symptom Assessment for Rosacea Facial Redness (SA-RFR) Item # 4 at Hours 3, 6, 9 and 12 on Day 29
Time frame: Baseline, Day 29 (Hours 3, 6, 9 and 12)
Percentage of Participants With at Least a 1-Grade Improvement (Decrease) From Baseline on SSA at Hour 1 on Day 1
Time frame: Baseline, Day 1 (Hour 1)

Results and safety

Results posted to the registry on 2 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxymetazoline HCL Cream 1.0%	224	213
Vehicle	221	216

Primary outcome: Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment for Rosacea Facial Redness (SSA) 5-point Scales

Time frame: Baseline, Day 29 (Hours 3, 6, 9 and 12). Number. Unit: percentage of participants

Measure	Oxymetazoline HCL Cream 1.0% n = 224	Vehicle n = 221
Day 29 (Hour 3)	14.3	7.4
Day 29 (Hour 6)	13.4	4.8
Day 29 (Hour 9)	15.5	8.5
Day 29 (Hour 12)	12.3	6.1

Population analysed: Intent-to-treat (ITT) Population included all randomized participants.

5 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
Oxymetazoline HCL Cream 1.0%	3 of 223 (1.3%)	0 of 223 (0%)	Not reported
Vehicle	2 of 221 (0.9%)	0 of 221 (0%)	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 3 study testing Oxymetazoline HCL Cream 1.0% 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 2 Aug 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 Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment for Rosacea Facial Redness (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?

On the ClinicalTrials.gov record for NCT02132117.

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.