Trial Outcomes & Findings for Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea (NCT NCT01318733)
NCT ID: NCT01318733
Last Updated: 2021-02-18
Results Overview
Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema 1. / Almost clear; slight redness 2. / Mild erythema; definite redness 3. / Moderate erythema; marked redness 4. / Severe erythema; fiery redness Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
449 participants
Primary outcome timeframe
Over 1 year
Results posted on
2021-02-18
Participant Flow
Participant milestones
| Measure |
CD07805/47 Gel 0.5%
CD07805/47 Gel 0.5% once daily
|
|---|---|
|
Overall Study
STARTED
|
449
|
|
Overall Study
COMPLETED
|
279
|
|
Overall Study
NOT COMPLETED
|
170
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
Baseline characteristics by cohort
| Measure |
CD07805/47 Gel 0.5%
n=449 Participants
CD07805/47 Gel 0.5% once daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
395 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
54 Participants
n=5 Participants
|
|
Age, Continuous
|
50.9 years
STANDARD_DEVIATION 12.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
336 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
449 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Over 1 yearStatic evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema 1. / Almost clear; slight redness 2. / Mild erythema; definite redness 3. / Moderate erythema; marked redness 4. / Severe erythema; fiery redness Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1.
Outcome measures
| Measure |
CD07805/47 Gel 0.5% QD
n=449 Participants
|
|---|---|
|
Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.
Day 1 / Hour 3
|
-1.5 scores on a scale
Standard Deviation .88
|
|
Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.
Week 1/ Hour 3
|
-1.4 scores on a scale
Standard Deviation .85
|
|
Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.
Month 1/ Hour 3
|
-1.5 scores on a scale
Standard Deviation .83
|
|
Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.
Month 3 / Hour 3
|
-1.7 scores on a scale
Standard Deviation .84
|
|
Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.
Month 6 / Hour 3
|
-1.8 scores on a scale
Standard Deviation .88
|
|
Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.
Month 9 / Hour 3
|
-1.7 scores on a scale
Standard Deviation .9
|
|
Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.
Month 12 / Hour 3
|
-1.8 scores on a scale
Standard Deviation .83
|
Adverse Events
CD07805/47 Gel 0.5%
Serious events: 12 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CD07805/47 Gel 0.5%
n=449 participants at risk
|
|---|---|
|
Infections and infestations
Abscess tooth w/ secondary submandibular infection
|
0.22%
1/449 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis of left hip
|
0.22%
1/449 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Advanced squamous cell carcinoma of the lung
|
0.22%
1/449 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.22%
1/449 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
0.22%
1/449 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal carcinoma
|
0.22%
1/449 • Number of events 1
|
|
Gastrointestinal disorders
Distal Esophageal Schatzki's Ring
|
0.22%
1/449 • Number of events 1
|
|
Cardiac disorders
Unstable Angina
|
0.22%
1/449 • Number of events 1
|
|
Reproductive system and breast disorders
Right Ovarian Cyst
|
0.22%
1/449 • Number of events 1
|
|
Cardiac disorders
Sustained Ventricular Tachycardia
|
0.22%
1/449 • Number of events 1
|
|
Infections and infestations
Atypical Pneumonia
|
0.22%
1/449 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.22%
1/449 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.22%
1/449 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Synovitis Right Ankle
|
0.22%
1/449 • Number of events 1
|
|
Reproductive system and breast disorders
Persistent Abnormal Uterine Bleeding
|
0.22%
1/449 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bilateral Achilles Tendon ruptures
|
0.22%
1/449 • Number of events 1
|
Other adverse events
| Measure |
CD07805/47 Gel 0.5%
n=449 participants at risk
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.8%
35/449
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
5.3%
24/449
|
|
Vascular disorders
Flushing
|
10.2%
46/449
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60