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NCT Number: NCT02131636

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

This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.

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Key information

Conditions

Erythema Pathological Conditions, Signs and Symptoms Rosacea Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lynchburg, Virginia, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Moderate to severe persistent facial erythema associated with rosacea.

Exclusion criteria

  • Greater than 3 inflammatory lesions on the face
  • Current treatment with monoamine oxidase (MAO) inhibitors
  • Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogren's syndrome.

Treatment and study plan

AGN-199201

Drug

AGN-199201 applied to the face once daily for 29 days.

Vehicle to AGN-199201

Drug

Vehicle to AGN-199201 applied to the face once daily for 29 days.

Primary outcomes

  1. Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales

    Time frame: Baseline, Day 29 (Hours 3, 6, 9, and 12)

    The investigator assessed the patient's overall severity of erythema in the treatment area on the 5 point CEA scale (ranging from 0=clear skin with no signs of erythema to 4=severe erythema/fiery redness). The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) on both CEA and SSA from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.

Secondary outcomes

  1. Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale

    Time frame: Baseline, Day 29 (Hours 3, 6, 9, and 12)

    The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.

  2. Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)

    Time frame: Baseline, Day 29 (Hours 3, 6, 9, and 12)

    Rosacea facial redness in the treatment area was measured by DIA. The percent change was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. Baseline was defined as the measurement at predose on Day 1. A negative number change from baseline indicates a decrease in facial redness (improvement), and a positive number change from baseline indicates an increase in facial redness (worsening).

  3. Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9

    Time frame: Day 29 (Hours 3, 6, 9, and 12)

    The SA-RFR questionnaire item 9 is completed by patients assessing treatment satisfaction on facial redness. Patients reporting treatment satisfaction as "very satisfied" or "satisfied" are noted. The percentage of patients was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29.

  4. Change From Baseline on the SA-RFR Questionnaire Item #4

    Time frame: Baseline, Day 29 (Hours 3, 6, 9, and 12)

    The SA-RFR questionnaire item 4 is completed by patients assessing how much their face burned due to facial redness on a 5 point scale (range 0=does not burn at all and 4=burns a lot). Patients were evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. A lower score change from baseline (negative number) indicates a decrease in facial redness (improvement), and a higher score change from baseline (positive number) indicates an increase in facial burning (worsening).

  5. Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale

    Time frame: Baseline, Day 1 (Hour 1)

    The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 1 grade decrease (improvement) on the SSA from baseline at Day 1 hour 1. Baseline was defined as the measurement at predose on Day 1.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 6, 2014
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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