AGN-199201 for the Treatment of Erythema With Rosacea

November 15, 2019 updated by: Allergan
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

357

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Redness of the skin caused by rosacea

Exclusion Criteria:

  • ≥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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AGN-199201 Dose A Once Daily
AGN-199201 Dose A applied once daily to the face for 28 days.
Drug: AGN-199201 Dose A
AGN-199201 Dose A applied once or twice daily to the face for 28 days.
Experimental: AGN-199201 Dose B Once Daily
AGN-199201 Dose B applied once daily to the face for 28 days.
Drug: AGN-199201 Dose B
AGN-199201 Dose B applied once or twice daily to the face for 28 days.
Experimental: AGN-199201 Dose C Once Daily
AGN-199201 Dose C applied once daily to the face for 28 days.
Drug: AGN-199201 Dose C
AGN-199201 Dose C applied once or twice daily to the face for 28 days.
Placebo Comparator: AGN-199201 Vehicle Once Daily
AGN-199201 Vehicle applied once daily to the face for 28 days.
Drug: AGN-199201 Vehicle
AGN-199201 Vehicle applied once or twice daily to the face for 28 days.
Experimental: AGN-199201 Dose A Twice Daily
AGN-199201 Dose A applied twice daily to the face for 28 days.
Drug: AGN-199201 Dose A
AGN-199201 Dose A applied once or twice daily to the face for 28 days.
Experimental: AGN-199201 Dose B Twice Daily
AGN-199201 Dose B applied twice daily to the face for 28 days.
Drug: AGN-199201 Dose B
AGN-199201 Dose B applied once or twice daily to the face for 28 days.
Experimental: AGN-199201 Dose C Twice Daily
AGN-199201 Dose C applied twice daily to the face for 28 days.
Drug: AGN-199201 Dose C
AGN-199201 Dose C applied once or twice daily to the face for 28 days.
Placebo Comparator: AGN-199201 Vehicle Twice Daily
AGN-199201 Vehicle applied twice daily to the face for 28 days.
Drug: AGN-199201 Vehicle
AGN-199201 Vehicle applied once or twice daily to the face for 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Day 28-hours 2 to 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (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.
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
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.
Baseline, Day 28-hour 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

November 26, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199201-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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