Who is sponsoring NCT01579084?

NCT01579084 is sponsored by Allergan.

What condition does NCT01579084 study?

NCT01579084 studies Rosacea, Erythema.

What drugs are being tested in NCT01579084?

Interventions: AGN-199201 Formulation A, AGN-199201 Formulation B, AGN-199201 Formulation C, AGN-199201 Vehicle.

What is the status of NCT01579084?

NCT01579084 is currently COMPLETED.

Last reviewed 2019-11-15 · How we verify

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

NCT01579084 Phase 1 COMPLETED Results posted

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

Details

Lead sponsor	Allergan
Phase	Phase 1
Status	COMPLETED
Enrolment	64
Start date	2012-04
Completion	2012-06

Conditions

Rosacea
Erythema

Interventions

AGN-199201 Formulation A
AGN-199201 Formulation B
AGN-199201 Formulation C
AGN-199201 Vehicle

Primary outcomes

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 — Baseline, Day 1-hour 6
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 — Baseline, Day 5-hour 6
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.

Countries

United States