Trial Outcomes & Findings for Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis (NCT NCT03837743)
NCT ID: NCT03837743
Last Updated: 2022-09-02
Results Overview
The IGA of the Target Plaques will be determined on a 5-point scale. 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
Results posted on
2022-09-02
Participant Flow
This was a multi-site study conducted at five sites in the United States of America. Date first subject enrolled: March 20, 2019 and date last subject completed: November 7, 2019.
Unit of analysis: lesions
Participant milestones
| Measure |
DUR-928 Topical Solution and Vehicle Topical Solution
DUR-928 Topical Solution and Vehicle Topical Solution separately applied topically once daily to one target lesion on an arm of a subject for approximately four weeks. Each arm of a subject containing one target lesion was allocated to a different intervention.
DUR-928 Topical Solution: Topical solution containing active drug
Vehicle Topical Solution: Topical solution containing no active drug
|
|---|---|
|
Overall Study
STARTED
|
25 50
|
|
Overall Study
DUR-928 Topical Solution Lesion
|
25 25
|
|
Overall Study
Vehicle Topical Solution Lesion
|
25 25
|
|
Overall Study
COMPLETED
|
22 44
|
|
Overall Study
NOT COMPLETED
|
3 6
|
Reasons for withdrawal
| Measure |
DUR-928 Topical Solution and Vehicle Topical Solution
DUR-928 Topical Solution and Vehicle Topical Solution separately applied topically once daily to one target lesion on an arm of a subject for approximately four weeks. Each arm of a subject containing one target lesion was allocated to a different intervention.
DUR-928 Topical Solution: Topical solution containing active drug
Vehicle Topical Solution: Topical solution containing no active drug
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
DUR-928 Topical Solution and Vehicle Topical Solution
n=25 Participants
DUR-928 Topical Solution and Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
DUR-928 Topical Solution: Topical solution containing active drug Vehicle Topical Solution: Topical solution containing no active drug
|
|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 11.32 • n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)Population: ITT Population
The IGA of the Target Plaques will be determined on a 5-point scale. 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe
Outcome measures
| Measure |
DUR-928 Topical Solution
n=25 Participants
DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
DUR-928 Topical Solution: Topical solution containing active drug
|
Vehicle Topical Solution
n=25 Participants
Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
Vehicle Topical Solution: Topical solution containing no active drug
|
|---|---|---|
|
The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score.
Week 4 (change from baseline)
|
-0.8 score on a scale
Standard Deviation 0.83
|
-1.0 score on a scale
Standard Deviation 0.93
|
|
The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score.
Week 8 (change from baseline)
|
-0.6 score on a scale
Standard Deviation 1.00
|
-0.8 score on a scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)Each clinical sign (plaque elevation, scaling, erythema) will be graded on a 5-point scale.0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe.
Outcome measures
| Measure |
DUR-928 Topical Solution
n=25 Participants
DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
DUR-928 Topical Solution: Topical solution containing active drug
|
Vehicle Topical Solution
n=25 Participants
Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
Vehicle Topical Solution: Topical solution containing no active drug
|
|---|---|---|
|
The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema)
Week 4 (Clinical Signs of Psoriasis - Plaque Elevation-Change from Baseline)
|
-1.0 score on a scale
Standard Deviation 0.88
|
-1.2 score on a scale
Standard Deviation 0.94
|
|
The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema)
Week 8 (Clinical Signs of Psoriasis - Plaque Elevation-Change from Baseline)
|
-0.7 score on a scale
Standard Deviation 0.98
|
-0.9 score on a scale
Standard Deviation 1.06
|
|
The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema)
Week 4 (Clinical Signs of Psoriasis - scaling-Change from Baseline)
|
-0.8 score on a scale
Standard Deviation 0.89
|
-1.1 score on a scale
Standard Deviation 1.06
|
|
The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema)
Week 8 (Clinical Signs of Psoriasis - scaling-Change from Baseline)
|
-0.6 score on a scale
Standard Deviation 0.95
|
-0.8 score on a scale
Standard Deviation 1.18
|
|
The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema)
Week 4 (Clinical Signs of Psoriasis - erythema-Change from Baseline)
|
-1.0 score on a scale
Standard Deviation 0.88
|
-1.1 score on a scale
Standard Deviation 1.00
|
|
The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema)
Week 8 (Clinical Signs of Psoriasis - erythema-Change from Baseline)
|
-0.9 score on a scale
Standard Deviation 0.97
|
-1.1 score on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)The LPSI is a sum of all three parameters (sum range of 0-12, with 12 being a worse outcome). Three parameters are plaque elevation, scaling, and erythema, each rated 0-4, 0=clear to 4=severe.
Outcome measures
| Measure |
DUR-928 Topical Solution
n=25 Participants
DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
DUR-928 Topical Solution: Topical solution containing active drug
|
Vehicle Topical Solution
n=25 Participants
Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
Vehicle Topical Solution: Topical solution containing no active drug
|
|---|---|---|
|
The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI)
week 4 (change from Baseline)
|
-2.7 score on a scale
Standard Deviation 2.40
|
-3.4 score on a scale
Standard Deviation 2.76
|
|
The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI)
week 8 (change from Baseline)
|
-2.3 score on a scale
Standard Deviation 2.69
|
-2.8 score on a scale
Standard Deviation 3.05
|
SECONDARY outcome
Timeframe: Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)Population: ITT population
The surface areas of Target Plaque A (plaque on left arm) and Target Plaque B (plaque on right arm) will be measured.
Outcome measures
| Measure |
DUR-928 Topical Solution
n=25 Participants
DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
DUR-928 Topical Solution: Topical solution containing active drug
|
Vehicle Topical Solution
n=25 Participants
Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
Vehicle Topical Solution: Topical solution containing no active drug
|
|---|---|---|
|
The Change From Baseline as Assessed by the Target Plaque Area.
Week 4 (change from Baseline)
|
-2.5 cm^2
Standard Deviation 11.02
|
-7.4 cm^2
Standard Deviation 10.88
|
|
The Change From Baseline as Assessed by the Target Plaque Area.
Week 8 (change from Baseline)
|
-5.8 cm^2
Standard Deviation 10.26
|
-8.3 cm^2
Standard Deviation 7.85
|
SECONDARY outcome
Timeframe: Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)Population: ITT Population
The I-NRS score is based on an 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable."
Outcome measures
| Measure |
DUR-928 Topical Solution
n=25 Participants
DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
DUR-928 Topical Solution: Topical solution containing active drug
|
Vehicle Topical Solution
n=25 Participants
Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
Vehicle Topical Solution: Topical solution containing no active drug
|
|---|---|---|
|
The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus.
Week 4 (change from baseline)
|
-1.7 units on a scale
Standard Deviation 2.19
|
-1.7 units on a scale
Standard Deviation 1.84
|
|
The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus.
Week 8 (change from baseline)
|
-1.6 units on a scale
Standard Deviation 2.34
|
-1.5 units on a scale
Standard Deviation 2.11
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)Population: ITT Population
The Target Plaque Comparison is scored on a 3-point scale: 1A = Target Plaque A is better than Target Plaque B, 0 = Target Plaque A is the same as Target Plaque B, and 1B = Target Plaque A is worse than Target Plaque B.
Outcome measures
| Measure |
DUR-928 Topical Solution
n=23 Participants
DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
DUR-928 Topical Solution: Topical solution containing active drug
|
Vehicle Topical Solution
Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
Vehicle Topical Solution: Topical solution containing no active drug
|
|---|---|---|
|
The Change From Baseline as Assessed on the Target Plaque Comparison
Week 4 : Active Better
|
2 participants
|
—
|
|
The Change From Baseline as Assessed on the Target Plaque Comparison
Week 4 : Same
|
13 participants
|
—
|
|
The Change From Baseline as Assessed on the Target Plaque Comparison
Week 4 : Active Worse
|
8 participants
|
—
|
|
The Change From Baseline as Assessed on the Target Plaque Comparison
Week 8 : Active Better
|
3 participants
|
—
|
|
The Change From Baseline as Assessed on the Target Plaque Comparison
Week 8 : Same
|
11 participants
|
—
|
|
The Change From Baseline as Assessed on the Target Plaque Comparison
Week 8 : Active Worse
|
8 participants
|
—
|
Adverse Events
DUR-928 Topical Solution and Vehicle Topical Solution, Safety Population
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
DUR-928 Topical Solution, Safety Population Experiencing a TEAE at the Treatment Application Site.
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Vehicle Topical Solution, Safety Population Experiencing a TEAE at the Treatment Application Site.
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DUR-928 Topical Solution and Vehicle Topical Solution, Safety Population
n=25 participants at risk
DUR-928 Topical Solution and Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks. This group reflects all TEAEs collected for the safety population, including those that are treatment application site specific.
|
DUR-928 Topical Solution, Safety Population Experiencing a TEAE at the Treatment Application Site.
n=25 participants at risk
DUR-928 Topical Solution: Topical solution containing active drug applied topically once daily to one target lesion on an arm for approximately four weeks.
This treatment arm was only reported if the TEAE was local to the treatment application site.
|
Vehicle Topical Solution, Safety Population Experiencing a TEAE at the Treatment Application Site.
n=25 participants at risk
Vehicle Topical Solution: Topical solution containing no active drug applied topically once daily to one target lesion on an arm for approximately four weeks.
This treatment arm was only reported if the TEAE was local to the treatment application site.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
General disorders
Application site erythema
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
General disorders
Application site fissure
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
General disorders
Application site haemorrhage
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
General disorders
Application site injury
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
0.00%
0/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
General disorders
Application site pain
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
General disorders
Application site pruritus
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
Infections and infestations
Ear infection
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
Investigations
Blood urine
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
Renal and urinary disorders
Nephrolithiasis
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
4.0%
1/25 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
—
0/0 • Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
|
Additional Information
Executive Director of Regulatory Affairs
DURECT Corporation
Phone: 408-777-1829
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure agreement provides that if sponsor has not submitted a manuscript for publication within 12 months after the date of data lock and analysis at study completion at all sites, the PI can review results communications prior to public release and can embargo communications regarding trial results for a period up to 120 days from the time submitted to the sponsor for review. The PI cannot disclose SPONSOR Confidential Information without prior consent.
- Publication restrictions are in place
Restriction type: OTHER