Trial Outcomes & Findings for Efficacy and Safety of Vascana® in Subjects With Secondary Raynaud's Phenomenon (NCT NCT02688270)
NCT ID: NCT02688270
Last Updated: 2022-11-02
Results Overview
Change from baseline to visit 6 in peak Main Raynaud's Symptom (MRS) severity. Raynaud's symptoms will be assessed separately using a 0 to100-mm Visual Analog Scale (VAS) for pain, numbness, and tingling where 0 mm = no symptom and 100 mm = most severe symptom.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
6 weeks
Results posted on
2022-11-02
Participant Flow
Participant milestones
| Measure |
Treatment Sequence A
Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vehicle cream
Vascana (0.9% nitroglycerin cream): Study drug administered topically
Vehicle Cream (placebo): Vehicle administered topically
|
Treatment Sequence B
Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vehicle cream, Vascana® (0.9% nitroglycerin cream)
Vascana (0.9% nitroglycerin cream): Study drug administered topically
Vehicle Cream (placebo): Vehicle administered topically
|
Treatment Sequence C
Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vascana® (0.9% nitroglycerin cream)
Vascana (0.9% nitroglycerin cream): Study drug administered topically
Vehicle Cream (placebo): Vehicle administered topically
|
Treatment Sequence D
Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vascana® (0.9% nitroglycerin cream), Vehicle cream
Vascana (0.9% nitroglycerin cream): Study drug administered topically
Vehicle Cream (placebo): Vehicle administered topically
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
17
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Vascana® in Subjects With Secondary Raynaud's Phenomenon
Baseline characteristics by cohort
| Measure |
Treatment Sequence A
n=16 Participants
Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vehicle cream
Vascana (0.9% nitroglycerin cream): Study drug administered topically
Vehicle Cream (placebo): Vehicle administered topically
|
Treatment Sequence B
n=16 Participants
Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vehicle cream, Vascana® (0.9% nitroglycerin cream)
Vascana (0.9% nitroglycerin cream): Study drug administered topically
Vehicle Cream (placebo): Vehicle administered topically
|
Treatment Sequence C
n=17 Participants
Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vascana® (0.9% nitroglycerin cream)
Vascana (0.9% nitroglycerin cream): Study drug administered topically
Vehicle Cream (placebo): Vehicle administered topically
|
Treatment Sequence D
n=16 Participants
Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vascana® (0.9% nitroglycerin cream), Vehicle cream
Vascana (0.9% nitroglycerin cream): Study drug administered topically
Vehicle Cream (placebo): Vehicle administered topically
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 13.37 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 11.42 • n=7 Participants
|
52.1 years
STANDARD_DEVIATION 16.24 • n=5 Participants
|
47.7 years
STANDARD_DEVIATION 13.34 • n=4 Participants
|
51.4 years
STANDARD_DEVIATION 13.61 • n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
17 participants
n=5 Participants
|
16 participants
n=4 Participants
|
65 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 weeksChange from baseline to visit 6 in peak Main Raynaud's Symptom (MRS) severity. Raynaud's symptoms will be assessed separately using a 0 to100-mm Visual Analog Scale (VAS) for pain, numbness, and tingling where 0 mm = no symptom and 100 mm = most severe symptom.
Outcome measures
| Measure |
Vascana
n=65 Participants
Vascana (0.9% nitroglycerin cream): Study drug administered topically
|
Vehicle Cream
n=65 Participants
Vehicle Cream (placebo): Vehicle administered topically
|
|---|---|---|
|
Raynaud's Symptom Severity (Change From Baseline)
|
-20.19 score on a scale
Interval -26.63 to -13.75
|
-18.63 score on a scale
Interval -25.07 to -12.19
|
PRIMARY outcome
Timeframe: 6 weeksOutcome measures
| Measure |
Vascana
n=65 Participants
Vascana (0.9% nitroglycerin cream): Study drug administered topically
|
Vehicle Cream
n=65 Participants
Vehicle Cream (placebo): Vehicle administered topically
|
|---|---|---|
|
Raynaud's Symptom Severity (Percentage of Responders)
|
37 Participants
|
29 Participants
|
Adverse Events
Vascana
Serious events: 17 serious events
Other events: 1 other events
Deaths: 0 deaths
Vehicle Cream
Serious events: 16 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vascana
n=17 participants at risk；n=65 participants at risk
Vascana (0.9% nitroglycerin cream): Study drug administered topically
|
Vehicle Cream
n=16 participants at risk；n=65 participants at risk
Vehicle Cream (placebo): Vehicle administered topically
|
|---|---|---|
|
Vascular disorders
Blood Pressure Increased
|
12.3%
8/65 • Number of events 8 • 6 weeks
|
10.8%
7/65 • Number of events 7 • 6 weeks
|
|
Nervous system disorders
Nervous System Disorders
|
1.5%
1/65 • Number of events 1 • 6 weeks
|
6.2%
4/65 • Number of events 4 • 6 weeks
|
|
General disorders
General disorders and administration site conditions
|
4.6%
3/65 • Number of events 3 • 6 weeks
|
1.5%
1/65 • Number of events 1 • 6 weeks
|
|
Infections and infestations
Infections and infestations
|
3.1%
2/65 • Number of events 2 • 6 weeks
|
1.5%
1/65 • Number of events 1 • 6 weeks
|
|
Vascular disorders
Hypertension
|
1.5%
1/65 • Number of events 1 • 6 weeks
|
4.6%
3/65 • Number of events 3 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
3.1%
2/65 • Number of events 2 • 6 weeks
|
0.00%
0/65 • 6 weeks
|
Other adverse events
| Measure |
Vascana
n=17 participants at risk；n=65 participants at risk
Vascana (0.9% nitroglycerin cream): Study drug administered topically
|
Vehicle Cream
n=16 participants at risk；n=65 participants at risk
Vehicle Cream (placebo): Vehicle administered topically
|
|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/17 • 6 weeks
|
6.2%
1/16 • Number of events 1 • 6 weeks
|
|
Vascular disorders
Blood Pressure Increased
|
5.9%
1/17 • Number of events 1 • 6 weeks
|
12.5%
2/16 • Number of events 2 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place