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

November 15, 2019 updated by: Allergan
This study will evaluate the safety and tolerability of AGN-199201 for the treatment of erythema associated with rosacea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 1

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:

  • facial erythema associated with rosacea on both sides of the face

Exclusion Criteria:

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

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AGN-199201 Formulation A and B
AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily.
Drug: AGN-199201 Formulation A
AGN-199201 Formulation A applied to the face as per protocol twice daily.
Drug: AGN-199201 Formulation B
AGN-199201 Formulation B applied to the face as per protocol twice daily.
EXPERIMENTAL: AGN-199201 Formulation B and C
AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily.
Drug: AGN-199201 Formulation B
AGN-199201 Formulation B applied to the face as per protocol twice daily.
Drug: AGN-199201 Formulation C
AGN-199201 Formulation C applied to the face as per protocol twice daily.
EXPERIMENTAL: AGN-199201 Formulation C and A
AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily.
Drug: AGN-199201 Formulation A
AGN-199201 Formulation A applied to the face as per protocol twice daily.
Drug: AGN-199201 Formulation C
AGN-199201 Formulation C applied to the face as per protocol twice daily.
OTHER: AGN-199201 Formulation A and Vehicle
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.
Drug: AGN-199201 Formulation A
AGN-199201 Formulation A applied to the face as per protocol twice daily.
Drug: AGN-199201 Vehicle
AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.
OTHER: AGN-199201 Formulation B and Vehicle
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.
Drug: AGN-199201 Formulation B
AGN-199201 Formulation B applied to the face as per protocol twice daily.
Drug: AGN-199201 Vehicle
AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.
OTHER: AGN-199201 Formulation C and Vehicle
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.
Drug: AGN-199201 Formulation C
AGN-199201 Formulation C applied to the face as per protocol twice daily.
Drug: AGN-199201 Vehicle
AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.
EXPERIMENTAL: AGN-199201 Formulation A
AGN-199201 Formulation A applied to both sides of the face twice daily.
Drug: AGN-199201 Formulation A
AGN-199201 Formulation A applied to the face as per protocol twice daily.
EXPERIMENTAL: AGN-199201 Formulation B
AGN-199201 Formulation B applied to both sides of the face twice daily.
Drug: AGN-199201 Formulation B
AGN-199201 Formulation B applied to the face as per protocol twice daily.
EXPERIMENTAL: AGN-199201 Formulation C
AGN-199201 Formulation C applied to both sides of the face twice daily.
Drug: AGN-199201 Formulation C
AGN-199201 Formulation C applied to the face as per protocol twice daily.
PLACEBO_COMPARATOR: AGN-199201 Vehicle
AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily.
Drug: AGN-199201 Vehicle
AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Baseline, Day 5-hour 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
Baseline, Day1-hour 6, Day 5-hour 6

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

April 1, 2012

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

April 13, 2012

First Submitted That Met QC Criteria

April 16, 2012

First Posted (ESTIMATE)

April 17, 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

  • 199201-001

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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