AGN-199201 for the Treatment of Erythema With Rosacea

NCT ID: NCT01735201

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

PHASE2

Total Enrollment

357 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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AGN-199201 Dose A Once Daily

AGN-199201 Dose A applied once daily to the face for 28 days.

Group Type EXPERIMENTAL

AGN-199201 Dose A

Intervention Type DRUG

AGN-199201 Dose A applied once or twice daily to the face for 28 days.

AGN-199201 Dose B Once Daily

AGN-199201 Dose B applied once daily to the face for 28 days.

Group Type EXPERIMENTAL

AGN-199201 Dose B

Intervention Type DRUG

AGN-199201 Dose B applied once or twice daily to the face for 28 days.

AGN-199201 Dose C Once Daily

AGN-199201 Dose C applied once daily to the face for 28 days.

Group Type EXPERIMENTAL

AGN-199201 Dose C

Intervention Type DRUG

AGN-199201 Dose C applied once or twice daily to the face for 28 days.

AGN-199201 Vehicle Once Daily

AGN-199201 Vehicle applied once daily to the face for 28 days.

Group Type PLACEBO_COMPARATOR

AGN-199201 Vehicle

Intervention Type DRUG

AGN-199201 Vehicle applied once or twice daily to the face for 28 days.

AGN-199201 Dose A Twice Daily

AGN-199201 Dose A applied twice daily to the face for 28 days.

Group Type EXPERIMENTAL

AGN-199201 Dose A

Intervention Type DRUG

AGN-199201 Dose A applied once or twice daily to the face for 28 days.

AGN-199201 Dose B Twice Daily

AGN-199201 Dose B applied twice daily to the face for 28 days.

Group Type EXPERIMENTAL

AGN-199201 Dose B

Intervention Type DRUG

AGN-199201 Dose B applied once or twice daily to the face for 28 days.

AGN-199201 Dose C Twice Daily

AGN-199201 Dose C applied twice daily to the face for 28 days.

Group Type EXPERIMENTAL

AGN-199201 Dose C

Intervention Type DRUG

AGN-199201 Dose C applied once or twice daily to the face for 28 days.

AGN-199201 Vehicle Twice Daily

AGN-199201 Vehicle applied twice daily to the face for 28 days.

Group Type PLACEBO_COMPARATOR

AGN-199201 Vehicle

Intervention Type DRUG

AGN-199201 Vehicle applied once or twice daily to the face for 28 days.

Interventions

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AGN-199201 Dose A

AGN-199201 Dose A applied once or twice daily to the face for 28 days.

Intervention Type DRUG

AGN-199201 Dose B

AGN-199201 Dose B applied once or twice daily to the face for 28 days.

Intervention Type DRUG

AGN-199201 Dose C

AGN-199201 Dose C applied once or twice daily to the face for 28 days.

Intervention Type DRUG

AGN-199201 Vehicle

AGN-199201 Vehicle applied once or twice daily to the face for 28 days.

Intervention Type DRUG

Eligibility Criteria

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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
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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199201-002

Identifier Type: -

Identifier Source: org_study_id

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