AGN-199201 for the Treatment of Erythema With Rosacea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01735201
First received: November 26, 2012
Last updated: May 2, 2014
Last verified: May 2014
  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:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

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
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, see Learn About Clinical Studies.

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
Results First Received: May 2, 2014
Last Updated: May 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rosacea
Erythema
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014