AGN-199201 for the Treatment of Erythema With Rosacea

Allergan

Status and phase: Completed; Phase 2

Conditions: Erythema; Rosacea

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01735201

199201-002

Details and patient eligibility

About

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.

Enrollment: 357 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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357 participants in 8 patient groups, including a placebo group

AGN-199201 Dose A Once Daily

Experimental group

Description:

AGN-199201 Dose A applied once daily to the face for 28 days.

Treatment:

Drug: AGN-199201 Dose A

AGN-199201 Dose B Once Daily

Experimental group

Description:

AGN-199201 Dose B applied once daily to the face for 28 days.

Treatment:

Drug: AGN-199201 Dose B

AGN-199201 Dose C Once Daily

Experimental group

Description:

AGN-199201 Dose C applied once daily to the face for 28 days.

Treatment:

Drug: AGN-199201 Dose C

AGN-199201 Vehicle Once Daily

Placebo Comparator group

Description:

AGN-199201 Vehicle applied once daily to the face for 28 days.

Treatment:

Drug: AGN-199201 Vehicle

AGN-199201 Dose A Twice Daily

Experimental group

Description:

AGN-199201 Dose A applied twice daily to the face for 28 days.

Treatment:

Drug: AGN-199201 Dose A

AGN-199201 Dose B Twice Daily

Experimental group

Description:

AGN-199201 Dose B applied twice daily to the face for 28 days.

Treatment:

Drug: AGN-199201 Dose B

AGN-199201 Dose C Twice Daily

Experimental group

Description:

AGN-199201 Dose C applied twice daily to the face for 28 days.

Treatment:

Drug: AGN-199201 Dose C

AGN-199201 Vehicle Twice Daily

Placebo Comparator group

Description:

AGN-199201 Vehicle applied twice daily to the face for 28 days.

Treatment:

Drug: AGN-199201 Vehicle