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

NCT ID: NCT01579084

Last Updated: 2019-11-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-06-30

Brief Summary

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This study will evaluate the safety and tolerability of AGN-199201 for the treatment of erythema associated with rosacea.

Detailed Description

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Conditions

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Rosacea Erythema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

AGN-199201 Formulation A

Intervention Type DRUG

AGN-199201 Formulation A applied to the face as per protocol twice daily.

AGN-199201 Formulation B

Intervention Type DRUG

AGN-199201 Formulation B applied to the face as per protocol twice daily.

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.

Group Type EXPERIMENTAL

AGN-199201 Formulation B

Intervention Type DRUG

AGN-199201 Formulation B applied to the face as per protocol twice daily.

AGN-199201 Formulation C

Intervention Type DRUG

AGN-199201 Formulation C applied to the face as per protocol twice daily.

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.

Group Type EXPERIMENTAL

AGN-199201 Formulation A

Intervention Type DRUG

AGN-199201 Formulation A applied to the face as per protocol twice daily.

AGN-199201 Formulation C

Intervention Type DRUG

AGN-199201 Formulation C applied to the face as per protocol twice daily.

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.

Group Type OTHER

AGN-199201 Formulation A

Intervention Type DRUG

AGN-199201 Formulation A applied to the face as per protocol twice daily.

AGN-199201 Vehicle

Intervention Type DRUG

AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.

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.

Group Type OTHER

AGN-199201 Formulation B

Intervention Type DRUG

AGN-199201 Formulation B applied to the face as per protocol twice daily.

AGN-199201 Vehicle

Intervention Type DRUG

AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.

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.

Group Type OTHER

AGN-199201 Formulation C

Intervention Type DRUG

AGN-199201 Formulation C applied to the face as per protocol twice daily.

AGN-199201 Vehicle

Intervention Type DRUG

AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.

AGN-199201 Formulation A

AGN-199201 Formulation A applied to both sides of the face twice daily.

Group Type EXPERIMENTAL

AGN-199201 Formulation A

Intervention Type DRUG

AGN-199201 Formulation A applied to the face as per protocol twice daily.

AGN-199201 Formulation B

AGN-199201 Formulation B applied to both sides of the face twice daily.

Group Type EXPERIMENTAL

AGN-199201 Formulation B

Intervention Type DRUG

AGN-199201 Formulation B applied to the face as per protocol twice daily.

AGN-199201 Formulation C

AGN-199201 Formulation C applied to both sides of the face twice daily.

Group Type EXPERIMENTAL

AGN-199201 Formulation C

Intervention Type DRUG

AGN-199201 Formulation C applied to the face as per protocol twice daily.

AGN-199201 Vehicle

AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily.

Group Type PLACEBO_COMPARATOR

AGN-199201 Vehicle

Intervention Type DRUG

AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.

Interventions

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AGN-199201 Formulation A

AGN-199201 Formulation A applied to the face as per protocol twice daily.

Intervention Type DRUG

AGN-199201 Formulation B

AGN-199201 Formulation B applied to the face as per protocol twice daily.

Intervention Type DRUG

AGN-199201 Formulation C

AGN-199201 Formulation C applied to the face as per protocol twice daily.

Intervention Type DRUG

AGN-199201 Vehicle

AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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199201-001

Identifier Type: -

Identifier Source: org_study_id

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