AGN-199201 for the Treatment of Erythema With Rosacea

Phase 2

Completed

• Conditions: Rosacea; Erythema
• Interventions: Drug: AGN-199201 Vehicle; Drug: AGN-199201 Dose B; Drug: AGN-199201 Dose A; Drug: AGN-199201 Dose C

• Registration Number: NCT01735201
• Lead Sponsor: Allergan

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2012-11-26
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-28
• Study Start: 2012-12
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Results First Submitted: 2014-05-02
• Results First Submitted QC: 2014-05-02
• Results First Posted: 2014-05-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 357

Inclusion Criteria

• Redness of the skin caused by rosacea

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AGN-199201 Vehicle Once Daily	AGN-199201 Vehicle	AGN-199201 Vehicle applied once daily to the face for 28 days.
AGN-199201 Dose B Once Daily	AGN-199201 Dose B	AGN-199201 Dose B applied once daily to the face for 28 days.
AGN-199201 Dose A Once Daily	AGN-199201 Dose A	AGN-199201 Dose A applied once daily to the face for 28 days.
AGN-199201 Dose C Once Daily	AGN-199201 Dose C	AGN-199201 Dose C applied once daily to the face for 28 days.
AGN-199201 Dose C Twice Daily	AGN-199201 Dose C	AGN-199201 Dose C applied twice daily to the face for 28 days.
AGN-199201 Vehicle Twice Daily	AGN-199201 Vehicle	AGN-199201 Vehicle applied twice daily to the face for 28 days.
AGN-199201 Dose A Twice Daily	AGN-199201 Dose A	AGN-199201 Dose A applied twice daily to the face for 28 days.
AGN-199201 Dose B Twice Daily	AGN-199201 Dose B	AGN-199201 Dose B applied twice daily to the face for 28 days.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA)	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

Name	Time	Method
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	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	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.