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AGN-199201 for the Treatment of Erythema With Rosacea

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01735201
First received: November 26, 2012
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Rosacea
Erythema
 Drug: AGN-199201 Dose A
Drug: AGN-199201 Dose B
Drug: AGN-199201 Dose C
Drug: AGN-199201 Vehicle
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Rosacea
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change from Baseline In Erythema as Assessed by the Clinician's Erythema Assessment (CEA) and Subject Self-Assessment (SSA) 5-Point Scales [ Time Frame: Baseline, Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline In Erythema as Assessed by the CEA and SSA 5-Point Scales [ Time Frame: Baseline, Day 28 Hour 0.5 ] [ Designated as safety issue: No ]
  • Change from Baseline In Erythema as Assessed by the CEA and SSA 5-Point Scales [ Time Frame: Baseline, Day 28 Hour 1 ] [ Designated as safety issue: No ]

Enrollment: 357
Study Start Date: December 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735201

Locations
United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01735201     History of Changes
Other Study ID Numbers: 199201-002
Study First Received: November 26, 2012
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rosacea
Erythema
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013