This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 8 weeks vs. vehicle application on treatment of mild to moderate rosacea.
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 8 weeks vs. vehicle application on treatment of mild to moderate rosacea. At Screening and Baseline all subjects must have Type 1 erythematotelangiectatic rosacea (ETR). The total duration of the study will be approximately 12 weeks. Participants will report for a Screening visit and if all inclusion criteria are met will undergo a washout period, between 2 days and 4 weeks, depending on current treatment. Subjects will then report for the Baseline visit. Subjects will come in for visits at Day 7 (Week 1), Day 28 (Week 4), and Day 56 (Week 8). A final visit will be conducted at Day 84 (Week 12). Efficacy will be assessed using Clinician Erythema Assessment (CEA), Investigator Global Assessment (IGA), Skindex16, and Patient Self-Assessment (PSA). Blood and urine samples will be collected for standard safety laboratory tests. Participant's safety will be monitored throughout the study. Investigators plan to enroll approximately 130 subjects. Randomization will be 1:1 so that equal numbers of subjects will be treated in each arm of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
Tampa Bay Medical Research
Clearwater, Florida, United States
Veritas Research Corp
Miami, Florida, United States
South Coast Research Center, Inc.
Miami, Florida, United States
FXM Research Corp.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Safety and tolerability endpoints will consist of all treatment-related adverse events reporting during the study duration.
Time frame: Baseline to Day 84
Proportion of Subjects With IGA Improvement at Week 8 Relative to Baseline.
IGA (Investigator's Global Assessment) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease). Improvement is defined as at least 1-grade change.
Time frame: Baseline to Day 56
Proportion of Subjects With CEA Improvement at Week 8 Relative to Baseline.
Clinical Erythema Assessment (CEA) was used to assess the extent of rosacea on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). Improvement is defined as at least 1-grade change.
Time frame: Baseline to Day 56
Change in IGA From Week 8 to Baseline.
IGA (Investigator's Global Assessment) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease). A higher grade change indicates greater improvement in disease.
Time frame: Baseline to Day 56
Change in CEA From Week 8 to Baseline.
Clinical Erythema Assessment (CEA) was used to assess the extent of rosacea on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). A higher grade change indicates greater improvement in disease.
Time frame: Baseline to Day 56
Change in Skindex 16 and Skindex 16 Sub Scores at Week 1, Week 4, Week 8 and Week 12 From Baseline.
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Miami, Florida, United States
FXM Research Miramar
Miramar, Florida, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Paddington Testing Co.
Philadelphia, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
West Houston Clinical Research Service
Houston, Texas, United States
The Skindex 16 questionnaire was assigned to subjects to examine the relationship between the subject's skin health and quality of life. Subjects scored 16 questions from 0 to 6 (0=never bothered, 6=always bothered). Total scores could range between 0 to 96, where a higher score is associated with a worse quality of life.
Time frame: Baseline to Day 84
Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline.
Subjects were asked to perform static ("snap-shot") evaluations of their rosacea-associated facial erythema severity using the Patient Self Assessment scale (PSA) at each study visit, and report the one integer that best describes the overall severity of their facial redness as seen in a mirror at the time of the evaluation on a scale of 0 to 4 (0=no redness, 1=very mild redness, 2=mild redness, 3=moderate redness, 4=severe redness). A higher grade change indicates greater improvement.
Time frame: Baseline to Day 84