Trial Outcomes & Findings for Evaluation of Rosacea-related Inflammatory Biochemical Markers in Adult Skin When Treated With Oracea® vs Placebo (NCT NCT01308619)
NCT ID: NCT01308619
Last Updated: 2022-08-01
Results Overview
Mean change in inflammatory lesion counts from baseline to week 12
COMPLETED
PHASE4
170 participants
baseline to week 12
2022-08-01
Participant Flow
First subject enrolled 9 May 2011, last subject last visit 2 July 2012
Participant milestones
| Measure |
Oracea®
Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules for 12 weeks
|
Placebo Capsules
Placebo capsules for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
86
|
|
Overall Study
COMPLETED
|
77
|
83
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Rosacea-related Inflammatory Biochemical Markers in Adult Skin When Treated With Oracea® vs Placebo
Baseline characteristics by cohort
| Measure |
Oracea®
n=84 Participants
Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
|
Placebo
n=86 Participants
placebo
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.6 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
48.7 years
STANDARD_DEVIATION 10.8 • n=107 Participants
|
49.1 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=99 Participants
|
86 participants
n=107 Participants
|
170 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline to week 12Mean change in inflammatory lesion counts from baseline to week 12
Outcome measures
| Measure |
Oracea®
n=84 Participants
Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
|
Placebo
n=86 Participants
placebo
|
|---|---|---|
|
Change From Baseline in Inflammatory Lesion Counts
|
-4.3 inflammatory lesions
Standard Deviation 7.9
|
-3.2 inflammatory lesions
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: baseline to week 12Population: Treatment success was defined as all subjects from either treatment group with a score of clear or near clear on the Investigator's Global Assessment (IGA) scale. Treatment failure was defined as all subjects from either treatment group with a score of mild, moderate, or severe on the IGA scale.
Mean change from baseline to week 12 in biochemical markers of rosacea and expression in skin samples. A biological marker is a substance used as an indicator of a biological state such as rosacea. Biochemical markers are serine protease activity and expression, metalloprotease activity and expression, and production of leucine leucine-37 \[LL-37\] peptide.
Outcome measures
| Measure |
Oracea®
n=49 Participants
Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
|
Placebo
n=111 Participants
placebo
|
|---|---|---|
|
Change From Baseline in Biochemical Markers of Rosacea From Tape Stripping and/or Skin Biopsy From Baseline to Week 12
Cathelicidin
|
-0.0931 micr grams protein
Standard Deviation 0.5491
|
-0.0379 micr grams protein
Standard Deviation 0.1545
|
|
Change From Baseline in Biochemical Markers of Rosacea From Tape Stripping and/or Skin Biopsy From Baseline to Week 12
KLK5
|
-0.0034 micr grams protein
Standard Deviation 0.0110
|
-0.0049 micr grams protein
Standard Deviation 0.0146
|
|
Change From Baseline in Biochemical Markers of Rosacea From Tape Stripping and/or Skin Biopsy From Baseline to Week 12
MMP9
|
-0.0017 micr grams protein
Standard Deviation 0.0100
|
-0.0021 micr grams protein
Standard Deviation 0.0233
|
|
Change From Baseline in Biochemical Markers of Rosacea From Tape Stripping and/or Skin Biopsy From Baseline to Week 12
Total Protease
|
-22351.6 micr grams protein
Standard Deviation 102888.2
|
-22540.9 micr grams protein
Standard Deviation 66146.2
|
SECONDARY outcome
Timeframe: Week 12Number of participants in each category of the Investigator's Global Assessment (IGA) scores at week 12. Investigator's Global Assessment evaluates papules and pustules of rosacea on a scale from 0 - 4 (0 = Clear, 1 = Near Clear, 2 = Mild, 3 = Moderate and 4 = Severe) with 0 being best and 4 being worst.
Outcome measures
| Measure |
Oracea®
n=84 Participants
Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
|
Placebo
n=86 Participants
placebo
|
|---|---|---|
|
Investigator's Global Assessment (IGA) Scores at Week 12
Moderate
|
12 participants
|
20 participants
|
|
Investigator's Global Assessment (IGA) Scores at Week 12
Clear
|
8 participants
|
2 participants
|
|
Investigator's Global Assessment (IGA) Scores at Week 12
Near Clear
|
23 participants
|
18 participants
|
|
Investigator's Global Assessment (IGA) Scores at Week 12
Mild
|
35 participants
|
31 participants
|
|
Investigator's Global Assessment (IGA) Scores at Week 12
Severe
|
6 participants
|
15 participants
|
SECONDARY outcome
Timeframe: baseline to week 12Mean change in Clinician's Erythema Assessment (CEA) from baseline to week 12. Clinician's Erythema Assessment evaluates erythema on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Significant and 4 = Severe) with 0 being best and 4 being worst.
Outcome measures
| Measure |
Oracea®
n=84 Participants
Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
|
Placebo
n=86 Participants
placebo
|
|---|---|---|
|
Change From Baseline in Clinician's Erythema Assessment (CEA) Scores
|
-1.0 units on a scale
Standard Deviation 2.9
|
-0.8 units on a scale
Standard Deviation 3.1
|
Adverse Events
Oracea®
Placebo
Serious adverse events
| Measure |
Oracea®
n=84 participants at risk
Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
|
Placebo
n=86 participants at risk
placebo
|
|---|---|---|
|
Cardiac disorders
Chest pain
|
1.2%
1/84 • Number of events 1
|
0.00%
0/86
|
|
Pregnancy, puerperium and perinatal conditions
Spontaneous abortion
|
1.2%
1/84 • Number of events 1
|
0.00%
0/86
|
Other adverse events
| Measure |
Oracea®
n=84 participants at risk
Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
|
Placebo
n=86 participants at risk
placebo
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
3.6%
3/84 • Number of events 4
|
1.2%
1/86 • Number of events 2
|
|
Infections and infestations
sinusitis
|
3.6%
3/84 • Number of events 3
|
2.3%
2/86 • Number of events 2
|
|
Infections and infestations
upper respiratory infection
|
2.4%
2/84 • Number of events 2
|
3.5%
3/86 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60