Trial Outcomes & Findings for Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa (NCT NCT02014376)
NCT ID: NCT02014376
Last Updated: 2020-01-13
Results Overview
The ARANZ SilhouetteStar™, a wound imaging, measurement, and documentation system providing accurate wound assessment, was used to measure the target wound at all visits. Information captured included photographic images, quantitative measures, and other target wound assessment data input to the device by the clinician, all obtained with no contact to the participant's skin. Information about the target wound's measurement history was available on this system so that the serial progression of the target wound status could also be calculated and presented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Baseline to 1 Month
Results posted on
2020-01-13
Participant Flow
Participant milestones
| Measure |
SD-101 Dermal Cream (6%)
SD-101 dermal cream (6%) applied topically once daily over the entire body for 90 days.
|
SD-101 Dermal Cream (3%)
SD-101 dermal cream (3%) applied topically once daily over the entire body for 90 days.
|
Vehicle (0%)
Vehicle dermal cream (SD-101 0%) applied topically once daily over the entire body for 90 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
17
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
15
|
16
|
17
|
|
Overall Study
COMPLETED
|
12
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
Reasons for withdrawal
| Measure |
SD-101 Dermal Cream (6%)
SD-101 dermal cream (6%) applied topically once daily over the entire body for 90 days.
|
SD-101 Dermal Cream (3%)
SD-101 dermal cream (3%) applied topically once daily over the entire body for 90 days.
|
Vehicle (0%)
Vehicle dermal cream (SD-101 0%) applied topically once daily over the entire body for 90 days.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
Baseline Characteristics
Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa
Baseline characteristics by cohort
| Measure |
SD-101 Dermal Cream (6%)
n=15 Participants
SD-101 dermal cream (6%) applied topically once daily over the entire body for 90 days.
|
SD-101 Dermal Cream (3%)
n=16 Participants
SD-101 dermal cream (3%) applied topically once daily over the entire body for 90 days.
|
Vehicle (0%)
n=17 Participants
Vehicle dermal cream (SD-101 0%) applied topically once daily over the entire body for 90 days.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
9.55 years
STANDARD_DEVIATION 9.189 • n=5 Participants
|
15.32 years
STANDARD_DEVIATION 15.565 • n=7 Participants
|
11.57 years
STANDARD_DEVIATION 10.358 • n=5 Participants
|
12.19 years
STANDARD_DEVIATION 12.029 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Epidermolysis Bullosa Subtype
Simplex
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Epidermolysis Bullosa Subtype
Recessive Dystrophic
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Epidermolysis Bullosa Subtype
Junctional non-Herlitz
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 1 MonthPopulation: Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug.
The ARANZ SilhouetteStar™, a wound imaging, measurement, and documentation system providing accurate wound assessment, was used to measure the target wound at all visits. Information captured included photographic images, quantitative measures, and other target wound assessment data input to the device by the clinician, all obtained with no contact to the participant's skin. Information about the target wound's measurement history was available on this system so that the serial progression of the target wound status could also be calculated and presented.
Outcome measures
| Measure |
SD-101 Dermal Cream (6%)
n=15 Participants
SD-101 dermal cream (6%) applied topically once daily over the entire body for 90 days.
|
SD-101 Dermal Cream (3%)
n=16 Participants
SD-101 dermal cream (3%) applied topically once daily over the entire body for 90 days.
|
Vehicle (0%)
n=17 Participants
Vehicle dermal cream (SD-101 0%) applied topically once daily over the entire body for 90 days.
|
|---|---|---|---|
|
Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment
Yes
|
8 Participants
|
6 Participants
|
7 Participants
|
|
Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment
No
|
7 Participants
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 2 and Month 3Population: Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug.
The ARANZ SilhouetteStar™, a wound imaging, measurement, and documentation system providing accurate wound assessment, was used to measure the target wound at all visits. Information captured included photographic images, quantitative measures, and other target wound assessment data input to the device by the clinician, all obtained with no contact to the participant's skin. Information about the target wound's measurement history was available on this system so that the serial progression of the target wound status could also be calculated and presented.
Outcome measures
| Measure |
SD-101 Dermal Cream (6%)
n=15 Participants
SD-101 dermal cream (6%) applied topically once daily over the entire body for 90 days.
|
SD-101 Dermal Cream (3%)
n=16 Participants
SD-101 dermal cream (3%) applied topically once daily over the entire body for 90 days.
|
Vehicle (0%)
n=17 Participants
Vehicle dermal cream (SD-101 0%) applied topically once daily over the entire body for 90 days.
|
|---|---|---|---|
|
Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment
No: Month 3
|
6 Participants
|
7 Participants
|
8 Participants
|
|
Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment
Yes: Month 2
|
9 Participants
|
7 Participants
|
7 Participants
|
|
Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment
No: Month 2
|
6 Participants
|
9 Participants
|
10 Participants
|
|
Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment
Yes: Month 3
|
9 Participants
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug.
The BSAI is a global measure of disease "spread" with weighting factors. Lesional skin consisted of area(s) that could contain any of the following: blisters, bullae, erosions, ulcerations, scabbing and eschars, as well as areas that are weeping, sloughing, oozing, crusted and denuded. The percentage, ranging from 0% to 100%, of affected body surface area was recorded for each defined body region (head/neck, upper limbs, trunk \[includes groin\], and lower limbs), multiplied by the weighting factor, and then summed for all body regions to calculate the BSAI. The BSAI affected with blisters and wounds was calculated at baseline and Month 3 to assess the total affected area. Percentage change from baseline was calculated as follows: Percentage change from baseline = 100\*(Post-baseline value minus Baseline value) divided by Baseline value. Mean percentage change from baseline in BSAI is reported. Only participants with data available for analysis at the specified time point are presented.
Outcome measures
| Measure |
SD-101 Dermal Cream (6%)
n=12 Participants
SD-101 dermal cream (6%) applied topically once daily over the entire body for 90 days.
|
SD-101 Dermal Cream (3%)
n=15 Participants
SD-101 dermal cream (3%) applied topically once daily over the entire body for 90 days.
|
Vehicle (0%)
n=17 Participants
Vehicle dermal cream (SD-101 0%) applied topically once daily over the entire body for 90 days.
|
|---|---|---|---|
|
Percentage Change From Baseline In Lesional Skin Based On Body Surface Area Index (BSAI) Measurements At Month 3
|
-28.02 percentage of BSAI
Standard Deviation 35.949
|
-42.52 percentage of BSAI
Standard Deviation 37.624
|
-5.75 percentage of BSAI
Standard Deviation 110.470
|
SECONDARY outcome
Timeframe: Baseline, Day 7Population: Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug.
The Itch Man Pruritus Assessment Tool was used to measure the intensity of itching. Itching was assessed and reported at Baseline and Day 7. For participants 6 months to 5 years of age, itching was assessed using the caretaker's response, while in participants 6 years and older, itching was self-reported.
Outcome measures
| Measure |
SD-101 Dermal Cream (6%)
n=15 Participants
SD-101 dermal cream (6%) applied topically once daily over the entire body for 90 days.
|
SD-101 Dermal Cream (3%)
n=16 Participants
SD-101 dermal cream (3%) applied topically once daily over the entire body for 90 days.
|
Vehicle (0%)
n=17 Participants
Vehicle dermal cream (SD-101 0%) applied topically once daily over the entire body for 90 days.
|
|---|---|---|---|
|
Participants Experiencing A Change From Baseline In Itching At Day 7
Improved
|
5 Participants
|
4 Participants
|
7 Participants
|
|
Participants Experiencing A Change From Baseline In Itching At Day 7
Not Improved
|
9 Participants
|
12 Participants
|
10 Participants
|
|
Participants Experiencing A Change From Baseline In Itching At Day 7
Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 7Population: Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug.
Pain was assessed at Baseline and Day 7. The presence and intensity of pain was assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale for participants 6 months to 3 years of age. For participants aged 4 years and older, the Wong Faces Pain Scale was used. Scores were attributed for each of the 5 categories in the FLACC scale from 0 to 2, which resulted in a total score between 0 and 10. The Wong Faces Pain scale used 1 item to rate pain on a 0 to 10 scale. Higher score values indicated more pain.
Outcome measures
| Measure |
SD-101 Dermal Cream (6%)
n=15 Participants
SD-101 dermal cream (6%) applied topically once daily over the entire body for 90 days.
|
SD-101 Dermal Cream (3%)
n=16 Participants
SD-101 dermal cream (3%) applied topically once daily over the entire body for 90 days.
|
Vehicle (0%)
n=17 Participants
Vehicle dermal cream (SD-101 0%) applied topically once daily over the entire body for 90 days.
|
|---|---|---|---|
|
Change From Baseline In Pain At Day 7
FLACC Pain Scale
|
0.50 score on a scale
Standard Deviation 0.707
|
-0.17 score on a scale
Standard Deviation 5.307
|
-1.60 score on a scale
Standard Deviation 2.881
|
|
Change From Baseline In Pain At Day 7
Wong Faces Pain Scale
|
0.91 score on a scale
Standard Deviation 2.119
|
-0.70 score on a scale
Standard Deviation 2.908
|
1.08 score on a scale
Standard Deviation 2.353
|
SECONDARY outcome
Timeframe: Week 2, Month 1, Month 2, and Month 3Population: Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, had received at least 1 application of study drug, and whose target wounds healed while receiving study drug.
In the event of a healed wound, where complete closure was confirmed, the extent of scarring was assessed as "Present" or "Absent" at all post-baseline visits (Week 2 and Months 1, 2, and 3).
Outcome measures
| Measure |
SD-101 Dermal Cream (6%)
n=9 Participants
SD-101 dermal cream (6%) applied topically once daily over the entire body for 90 days.
|
SD-101 Dermal Cream (3%)
n=9 Participants
SD-101 dermal cream (3%) applied topically once daily over the entire body for 90 days.
|
Vehicle (0%)
n=9 Participants
Vehicle dermal cream (SD-101 0%) applied topically once daily over the entire body for 90 days.
|
|---|---|---|---|
|
Participants With Scarring At Week 2, Month 1, Month 2, And Month 3
Week 2 · Present
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Scarring At Week 2, Month 1, Month 2, And Month 3
Week 2 · Absent
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Participants With Scarring At Week 2, Month 1, Month 2, And Month 3
Month 1 · Present
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Participants With Scarring At Week 2, Month 1, Month 2, And Month 3
Month 1 · Absent
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Participants With Scarring At Week 2, Month 1, Month 2, And Month 3
Month 2 · Present
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Participants With Scarring At Week 2, Month 1, Month 2, And Month 3
Month 2 · Absent
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Scarring At Week 2, Month 1, Month 2, And Month 3
Month 3 · Present
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Scarring At Week 2, Month 1, Month 2, And Month 3
Month 3 · Absent
|
0 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
SD-101 Dermal Cream (6%)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
SD-101 Dermal Cream (3%)
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Vehicle (0%)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SD-101 Dermal Cream (6%)
n=15 participants at risk
SD-101 dermal cream (6%) applied topically once daily over the entire body for 90 days.
|
SD-101 Dermal Cream (3%)
n=16 participants at risk
SD-101 dermal cream (3%) applied topically once daily over the entire body for 90 days.
|
Vehicle (0%)
n=17 participants at risk
Vehicle dermal cream (SD-101 0%) applied topically once daily over the entire body for 90 days.
|
|---|---|---|---|
|
Infections and infestations
Bacterial tracheitis
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Infections and infestations
Wound infection
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
Other adverse events
| Measure |
SD-101 Dermal Cream (6%)
n=15 participants at risk
SD-101 dermal cream (6%) applied topically once daily over the entire body for 90 days.
|
SD-101 Dermal Cream (3%)
n=16 participants at risk
SD-101 dermal cream (3%) applied topically once daily over the entire body for 90 days.
|
Vehicle (0%)
n=17 participants at risk
Vehicle dermal cream (SD-101 0%) applied topically once daily over the entire body for 90 days.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
25.0%
4/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
11.8%
2/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Infections and infestations
Otitis media
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Infections and infestations
Pharyngitis streptococcal
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Infections and infestations
Rhinitis
|
13.3%
2/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Infections and infestations
Skin infection
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Infections and infestations
Eye infection
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Infections and infestations
Folliculitis
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Infections and infestations
Otitis externa
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
General disorders
Pyrexia
|
33.3%
5/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
18.8%
3/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
11.8%
2/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
General disorders
Application site pain
|
13.3%
2/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
18.8%
3/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
General disorders
Pain
|
13.3%
2/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
General disorders
Application site discharge
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
General disorders
Irritability
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
2/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
12.5%
2/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
11.8%
2/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
11.8%
2/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Skin and subcutaneous tissue disorders
Blister
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
2/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
11.8%
2/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
13.3%
2/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
11.8%
2/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Nervous system disorders
Aphonia
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Injury, poisoning and procedural complications
Wound complication
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Eye disorders
Corneal disorder
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Eye disorders
Eye swelling
|
6.7%
1/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Metabolism and nutrition disorders
Protein deficiency
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
5.9%
1/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Immune system disorders
Food allergy
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
6.2%
1/16 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
0.00%
0/17 • From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 4 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60