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

Purpose

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

Condition	Intervention	Phase
Rosacea Erythema	Drug: AGN-199201 Formulation A and B Drug: AGN-199201 Formulation B and C Drug: AGN-199201 Formulation C and A Drug: AGN-199201 Formulatio A and AGN-199201 Vehicle Drug: AGN-199201 Formulation B and AGN-199201 Vehicle Drug: AGN-199201 Formulation C and AGN-199201 Vehicle Drug: AGN-199201 Formulation A Drug: AGN-199201 Formulation B Drug: AGN-199201 Formulation C Drug: AGN-199201 Vehicle	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	64
Study Start Date:	April 2012
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AGN-199201 Formulation A and B AGN-199201 Formulation A and B	Drug: AGN-199201 Formulation A and B AGN-199201 Formulation A will be applied to one side of the face twice daily and AGN-199201 Formulation B will be applied to the other side of the face twice daily
Experimental: AGN-199201 Formulation B and C AGN-199201 Formulation B and C	Drug: AGN-199201 Formulation B and C AGN-199201 Formulation B will be applied to one side of the face twice daily and AGN-199201 Formulation C will be applied to the other side of the face twice daily
Experimental: AGN-199201 Formulation C and A AGN-199201 Formulation C and A	Drug: AGN-199201 Formulation C and A AGN-199201 Formulation C will be applied to one side of the face twice daily and AGN-199201 Formulation A will be applied to the other side of the face twice daily
AGN-199201 Formulation A and AGN-199201 Vehicle AGN-199201 Formulation A and AGN-199201 Vehicle	Drug: AGN-199201 Formulatio A and AGN-199201 Vehicle AGN-199201 Formulation A will be applied to one side of the face twice daily and AGN-199201 vehicle (placebo) will be applied to the other side of the face twice daily
AGN-199201 Formulation B and AGN-199201 Vehicle AGN-199201 Formulation B and AGN-199201 Vehicle	Drug: AGN-199201 Formulation B and AGN-199201 Vehicle AGN-199201 Formulation B will be applied to one side of the face twice daily and AGN-199201 vehicle (placebo) will be applied to the other side of the face twice daily
AGN-199201 Formulation C and AGN-199201 Vehicle AGN-199201 Formulation C and AGN-199201 Vehicle	Drug: AGN-199201 Formulation C and AGN-199201 Vehicle AGN-199201 Formulation C will be applied to one side of the face twice daily and AGN-199201 vehicle (placebo) will be applied to the other side of the face twice daily
Experimental: AGN-199201 Formulation A AGN-199201 Formulation A	Drug: AGN-199201 Formulation A AGN-199201 Formulation A will be applied to both sides of the face twice daily
Experimental: AGN-199201 Formulation B AGN-199201 Formulation B	Drug: AGN-199201 Formulation B AGN-199201 Formulation B will be applied to both sides of the face twice daily
Experimental: AGN-199201 Formulation C AGN-199201 Formulation B	Drug: AGN-199201 Formulation C AGN-199201 Formulation C will be applied to both sides of the face twice daily
Placebo Comparator: AGN-199201 Vehicle AGN-199201 Vehicle (Placebo)	Drug: AGN-199201 Vehicle AGN-199201 vehicle (placebo) will be applied to both sides of the face twice daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

facial erythema associated wtih 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579084

Locations

United States, Texas

Austin, Texas, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01579084 History of Changes
Other Study ID Numbers:	199201-001
Study First Received:	April 13, 2012
Last Updated:	June 22, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Rosacea
Erythema
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013