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Vasoconstrictor

Oxymetazoline HCL Cream 1.0% for Laryngitis

Phase 3
Waitlist Available
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
-Moderate to severe persistent facial erythema associated with rosacea.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 29 (hours 3, 6, 9 and 12)
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal 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.

Eligible Conditions
  • Laryngitis
  • Erythema
  • Rosacea

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 29 (hours 3, 6, 9 and 12)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 29 (hours 3, 6, 9 and 12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rosacea
Secondary study objectives
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
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
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
+2 more

Side effects data

From 2015 Phase 3 trial • 440 Patients • NCT02095158
1%
Basal cell carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oxymetazoline HCL Cream 1.0%

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oxymetazoline HCL Cream 1.0%Experimental Treatment1 Intervention
Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
Group II: VehiclePlacebo Group1 Intervention
Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxymetazoline
FDA approved

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
276,240 Total Patients Enrolled
Medical DirectorStudy DirectorAllergan
2,894 Previous Clinical Trials
8,088,330 Total Patients Enrolled
~39 spots leftby Nov 2025
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