Trial Outcomes & Findings for Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea (NCT NCT01872715)
NCT ID: NCT01872715
Last Updated: 2022-08-23
Results Overview
VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
Baseline, Weeks 2, 6, and 12
Results posted on
2022-08-23
Participant Flow
Participant milestones
| Measure |
Oracea
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.
Oral dose for 12 weeks
Oracea
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Oracea
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.
Oral dose for 12 weeks
Oracea
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
Baseline characteristics by cohort
| Measure |
Oracea
n=24 Participants
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.
Oral dose for 12 weeks
Oracea
|
|---|---|
|
Age, Continuous
|
53.04 years
STANDARD_DEVIATION 11.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Years since the first rosacea diagnosis
|
5.75 years
STANDARD_DEVIATION 8.36 • n=5 Participants
|
|
Skin type
Dry
|
8 participants
n=5 Participants
|
|
Skin type
Normal
|
4 participants
n=5 Participants
|
|
Skin type
Oily
|
1 participants
n=5 Participants
|
|
Skin type
Combination
|
11 participants
n=5 Participants
|
|
Fistzpatrick Skin Type
I
|
2 participants
n=5 Participants
|
|
Fistzpatrick Skin Type
II
|
15 participants
n=5 Participants
|
|
Fistzpatrick Skin Type
III
|
5 participants
n=5 Participants
|
|
Fistzpatrick Skin Type
IV
|
2 participants
n=5 Participants
|
|
Fistzpatrick Skin Type
V
|
0 participants
n=5 Participants
|
|
Fistzpatrick Skin Type
VI
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 2, 6, and 12Population: Intent-to-Treat (ITT) population: All subjects who were enrolled and had at least 1 posttreatment administration evaluation. This is the primary population for efficacy analyses.
VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable
Outcome measures
| Measure |
Dissatisfied
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
|
Very Dissatisfied
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
|
Oracea
n=22 Participants
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.
Oral dose for 12 weeks
Oracea
|
1 = Near Clear
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
|
2 = Mild
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
|
|---|---|---|---|---|---|
|
Rosacea Score on the Visual Analog Scale
Baseline
|
—
|
—
|
4.50 units on a scale
Standard Deviation 1.81
|
—
|
—
|
|
Rosacea Score on the Visual Analog Scale
Week 2
|
—
|
—
|
4.52 units on a scale
Standard Deviation 1.87
|
—
|
—
|
|
Rosacea Score on the Visual Analog Scale
Week 6
|
—
|
—
|
3.77 units on a scale
Standard Deviation 1.93
|
—
|
—
|
|
Rosacea Score on the Visual Analog Scale
Week 12
|
—
|
—
|
3.06 units on a scale
Standard Deviation 2.34
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 6, and 12Population: Intent-to-Treat (ITT) population: All subjects who were enrolled and had at least 1 posttreatment administration evaluation. This is the primary population for efficacy analyses.
ROSACEA-SPECIFIC QUALITY OF LIFE INDEX©: average of scores to 22 questions on a 5 point scale (1 = never, 5 = all the time)
Outcome measures
| Measure |
Dissatisfied
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
|
Very Dissatisfied
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
|
Oracea
n=22 Participants
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.
Oral dose for 12 weeks
Oracea
|
1 = Near Clear
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
|
2 = Mild
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
|
|---|---|---|---|---|---|
|
Rosacea-Specific Quality of Life Index
Baseline
|
—
|
—
|
3.34 units on a scale
Standard Deviation 0.55
|
—
|
—
|
|
Rosacea-Specific Quality of Life Index
Week 2
|
—
|
—
|
3.07 units on a scale
Standard Deviation 0.56
|
—
|
—
|
|
Rosacea-Specific Quality of Life Index
Week 6
|
—
|
—
|
2.89 units on a scale
Standard Deviation 0.81
|
—
|
—
|
|
Rosacea-Specific Quality of Life Index
Week 12
|
—
|
—
|
2.85 units on a scale
Standard Deviation 0.86
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 6, and 12Patient Global Assessment (PGA) of Rosacea: 0 = clear, no signs or symptoms present; 1 = Near clear, 1 or 2 papules; 2 = mild, some (3 to 10) papules/pustules; 3 = moderate, moderate (11 to 19) number of papules and pustules; 4 = severe, numerous (≥ 20) papules/pustules; nodules
Outcome measures
| Measure |
Dissatisfied
n=22 Participants
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
|
Very Dissatisfied
n=22 Participants
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
|
Oracea
n=22 Participants
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.
Oral dose for 12 weeks
Oracea
|
1 = Near Clear
n=22 Participants
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
|
2 = Mild
n=22 Participants
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
|
|---|---|---|---|---|---|
|
Patient Global Assessment (PGA) of Rosacea Scores
Week 2
|
2 participants
|
0 participants
|
0 participants
|
4 participants
|
16 participants
|
|
Patient Global Assessment (PGA) of Rosacea Scores
Baseline
|
4 participants
|
0 participants
|
0 participants
|
1 participants
|
17 participants
|
|
Patient Global Assessment (PGA) of Rosacea Scores
Week 6
|
1 participants
|
0 participants
|
0 participants
|
10 participants
|
11 participants
|
|
Patient Global Assessment (PGA) of Rosacea Scores
Week 12
|
1 participants
|
0 participants
|
3 participants
|
14 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Week 2, 6, and 12The patient satisfaction question was answered by the subject at week 2, week 6, and week 12. The subject was asked how satisfied they were with this treatment (doxycycline MR) for rosacea.
Outcome measures
| Measure |
Dissatisfied
n=22 Participants
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
|
Very Dissatisfied
n=22 Participants
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
|
Oracea
n=22 Participants
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.
Oral dose for 12 weeks
Oracea
|
1 = Near Clear
n=22 Participants
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
|
2 = Mild
n=22 Participants
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
|
|---|---|---|---|---|---|
|
Patient Satisfaction Question
Week 2
|
2 participants
|
0 participants
|
1 participants
|
11 participants
|
8 participants
|
|
Patient Satisfaction Question
Week 6
|
2 participants
|
1 participants
|
4 participants
|
7 participants
|
8 participants
|
|
Patient Satisfaction Question
Week 12
|
2 participants
|
1 participants
|
8 participants
|
6 participants
|
5 participants
|
Adverse Events
Oracea
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oracea
n=24 participants at risk
Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.
Oral dose for 12 weeks
Oracea
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
2/24 • 12 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
3/24 • 12 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
2/24 • 12 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60