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AGN-199201 for the Treatment of Erythema With Rosacea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01735201
First Posted: November 28, 2012
Last Update Posted: May 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.


Enrollment: 357
Study Start Date: December 2012
Study Completion Date: June 2013
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735201


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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01735201     History of Changes
Other Study ID Numbers: 199201-002
First Submitted: November 26, 2012
First Posted: November 28, 2012
Results First Submitted: May 2, 2014
Results First Posted: May 30, 2014
Last Update Posted: May 30, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Rosacea
Erythema
Skin Diseases


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