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

Allergan

Status and phase: Completed; Phase 1

Conditions: Erythema; Rosacea

Treatments: Drug: AGN-199201 Vehicle; Drug: AGN-199201 Formulation A; Drug: AGN-199201 Formulation B; Drug: AGN-199201 Formulation C

Study type: Interventional

Funder types: Industry

Identifiers

NCT01579084

199201-001

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 10 patient groups, including a placebo group

AGN-199201 Formulation A and B

Experimental group

Description:

AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily.

Treatment:

Drug: AGN-199201 Formulation A

Drug: AGN-199201 Formulation B

AGN-199201 Formulation B and C

Experimental group

Description:

AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily.

Treatment:

Drug: AGN-199201 Formulation C

Drug: AGN-199201 Formulation B

AGN-199201 Formulation C and A

Experimental group

Description:

AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily.

Treatment:

Drug: AGN-199201 Formulation A

Drug: AGN-199201 Formulation C

AGN-199201 Formulation A and Vehicle

Other group

Description:

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.

Treatment:

Drug: AGN-199201 Formulation A

Drug: AGN-199201 Vehicle

AGN-199201 Formulation B and Vehicle

Other group

Description:

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.

Treatment:

Drug: AGN-199201 Vehicle

Drug: AGN-199201 Formulation B

AGN-199201 Formulation C and Vehicle

Other group

Description:

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.

Treatment:

Drug: AGN-199201 Vehicle

Drug: AGN-199201 Formulation C

AGN-199201 Formulation A

Experimental group

Description:

AGN-199201 Formulation A applied to both sides of the face twice daily.

Treatment:

Drug: AGN-199201 Formulation A

AGN-199201 Formulation B

Experimental group

Description:

AGN-199201 Formulation B applied to both sides of the face twice daily.

Treatment:

Drug: AGN-199201 Formulation B

AGN-199201 Formulation C

Experimental group

Description:

AGN-199201 Formulation C applied to both sides of the face twice daily.

Treatment:

Drug: AGN-199201 Formulation C

AGN-199201 Vehicle

Placebo Comparator group

Description:

AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily.

Treatment:

Drug: AGN-199201 Vehicle