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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01579084
First received: April 13, 2012
Last updated: September 12, 2013
Last verified: September 2013

April 13, 2012
September 12, 2013
April 2012
June 2012   (final data collection date for primary outcome measure)
  • Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1 [ Time Frame: Baseline, Day 1-hour 6 ] [ Designated as safety issue: No ]
    The percentage of responders was determined by facial sides 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 at Day 1. 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 Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 5 [ Time Frame: Baseline, Day 5-hour 6 ] [ Designated as safety issue: No ]
    The percentage of responders was determined by facial sides 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 at Day 5. 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 Patients with at Least a 2-grade Decrease from Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) [ Time Frame: Baseline, Day 5 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01579084 on ClinicalTrials.gov Archive Site
  • Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA [ Time Frame: Baseline, Day 1-hour 6, Day 5-hour 6 ] [ Designated as safety issue: No ]
    The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score at Day 1 and Day 5. 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.
  • Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA [ Time Frame: Baseline, Day1-hour 6, Day 5-hour 6 ] [ Designated as safety issue: No ]
    The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 1 and Day 5. 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 Patients with at Least a 2-grade Decrease from Baseline on CEA [ Time Frame: Baseline, Day 5 ] [ Designated as safety issue: No ]
  • Percentage of Patients with at Least a 2-grade Decrease from Baseline on SSA [ Time Frame: Baseline, Day 5 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea
Not Provided

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Rosacea
  • Erythema
  • Drug: AGN-199201 Formulation A
    AGN-199201 Formulation A applied to the face as per protocol twice daily.
  • Drug: AGN-199201 Formulation B
    AGN-199201 Formulation B applied to the face as per protocol twice daily.
  • Drug: AGN-199201 Formulation C
    AGN-199201 Formulation C applied to the face as per protocol twice daily.
  • Drug: AGN-199201 Vehicle
    AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.
  • Experimental: 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.
    Interventions:
    • Drug: AGN-199201 Formulation A
    • Drug: AGN-199201 Formulation B
  • Experimental: 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.
    Interventions:
    • Drug: AGN-199201 Formulation B
    • Drug: AGN-199201 Formulation C
  • Experimental: 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.
    Interventions:
    • Drug: AGN-199201 Formulation A
    • Drug: AGN-199201 Formulation C
  • 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.
    Interventions:
    • Drug: AGN-199201 Formulation A
    • Drug: AGN-199201 Vehicle
  • 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.
    Interventions:
    • Drug: AGN-199201 Formulation B
    • Drug: AGN-199201 Vehicle
  • 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.
    Interventions:
    • Drug: AGN-199201 Formulation C
    • Drug: AGN-199201 Vehicle
  • Experimental: AGN-199201 Formulation A
    AGN-199201 Formulation A applied to both sides of the face twice daily.
    Intervention: Drug: AGN-199201 Formulation A
  • Experimental: AGN-199201 Formulation B
    AGN-199201 Formulation B applied to both sides of the face twice daily.
    Intervention: Drug: AGN-199201 Formulation B
  • Experimental: AGN-199201 Formulation C
    AGN-199201 Formulation C applied to both sides of the face twice daily.
    Intervention: Drug: AGN-199201 Formulation C
  • Placebo Comparator: AGN-199201 Vehicle
    AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily.
    Intervention: Drug: AGN-199201 Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01579084
199201-001
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP