AGN-199201 for the Treatment of Erythema With Rosacea

NCT01735201 | Completed Phase 2 Results

• 1 other identifier: 199201-002
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 1

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.

Conditions

Rosacea; Erythema

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline, Day 28-hours 2 to 12

Secondary Outcomes (2)

• 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 on Both CEA and SSA at 1 Hour Post-Dose on Day 28

  Baseline, Day 28-hour 1

Study Arms (8)

AGN-199201 Dose A Once Daily

EXPERIMENTAL

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

Drug: AGN-199201 Dose A

AGN-199201 Dose B Once Daily

EXPERIMENTAL

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

Drug: AGN-199201 Dose B

AGN-199201 Dose C Once Daily

EXPERIMENTAL

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

Drug: AGN-199201 Dose C

AGN-199201 Vehicle Once Daily

PLACEBO COMPARATOR

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

Drug: AGN-199201 Vehicle

AGN-199201 Dose A Twice Daily

EXPERIMENTAL

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

Drug: AGN-199201 Dose A

AGN-199201 Dose B Twice Daily

EXPERIMENTAL

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

Drug: AGN-199201 Dose B

AGN-199201 Dose C Twice Daily

EXPERIMENTAL

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

Drug: AGN-199201 Dose C

AGN-199201 Vehicle Twice Daily

PLACEBO COMPARATOR

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

Drug: AGN-199201 Vehicle

Interventions

AGN-199201 Dose A DRUG

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

AGN-199201 Dose A Once Daily; AGN-199201 Dose A Twice Daily

AGN-199201 Dose B DRUG

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

AGN-199201 Dose B Once Daily; AGN-199201 Dose B Twice Daily

AGN-199201 Dose C DRUG

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

AGN-199201 Dose C Once Daily; AGN-199201 Dose C Twice Daily

AGN-199201 Vehicle DRUG

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

AGN-199201 Vehicle Once Daily; AGN-199201 Vehicle Twice Daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Redness of the skin caused by rosacea

You may not qualify if:

• ≥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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Austin, Texas, United States

Location

MeSH Terms

Conditions

Rosacea; Erythema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: November 28, 2012
• Study Start: December 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 18, 2019
• Results First Posted: May 30, 2014

Record last verified: 2019-11

Locations

US (1)