Trial Outcomes & Findings for A Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject (NCT NCT01737931)
NCT ID: NCT01737931
Last Updated: 2014-04-29
Results Overview
Skin irritation score of the application site 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment. The scale scoring criteria are 0(-): Negative, 0.5(±): Faint erythema, 1(+): Erythema, 2(++): Erythema + edema, 3(+++): Erythema + edema + papules, serous papule, vesicles, 4(++++): Coalescing vesicles.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
120 participants
Primary outcome timeframe
24 hours after 2 mg/24 hr patch removal
Results posted on
2014-04-29
Participant Flow
A total of 120 eligible subjects received the IMP treatment at least once, and 3 of them were withdrawn from the trial before topical treatment allocation due to subject request (1 subject) and for lack of efficacy evaluation (2 subjects).
Participant milestones
| Measure |
Topical Steroid
Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
|
Topical Antihistamine
Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
|
No-treatment
No treatment to the application sites after the patch removal
|
|---|---|---|---|
|
Overall Study
STARTED
|
38
|
40
|
39
|
|
Overall Study
COMPLETED
|
38
|
38
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Topical Steroid
Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
|
Topical Antihistamine
Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
|
No-treatment
No treatment to the application sites after the patch removal
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
A Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject
Baseline characteristics by cohort
| Measure |
Topical Steroid
n=38 Participants
Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
|
Topical Antihistamine
n=40 Participants
Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
|
No-treatment
n=39 Participants
No treatment to the application sites after the patch removal
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.7 years
STANDARD_DEVIATION 4.2 • n=99 Participants
|
26.7 years
STANDARD_DEVIATION 4.8 • n=107 Participants
|
26.1 years
STANDARD_DEVIATION 3.7 • n=206 Participants
|
26.5 years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
117 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
117 Participants
n=7 Participants
|
|
Region of Enrollment
Korea, Republic of
|
38 participants
n=99 Participants
|
40 participants
n=107 Participants
|
39 participants
n=206 Participants
|
117 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 24 hours after 2 mg/24 hr patch removalPopulation: Full analysis set (FAS) subjects with a score of ≥ 0.5 (±) at Day 3
Skin irritation score of the application site 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment. The scale scoring criteria are 0(-): Negative, 0.5(±): Faint erythema, 1(+): Erythema, 2(++): Erythema + edema, 3(+++): Erythema + edema + papules, serous papule, vesicles, 4(++++): Coalescing vesicles.
Outcome measures
| Measure |
Topical Steroid
n=19 Participants
Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
|
Topical Antihistamine
n=19 Participants
Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
|
No-treatment
n=20 Participants
No treatment to the application sites after the patch removal
|
|---|---|---|---|
|
Skin Irritation Score of the Application Site
|
0.237 Scores on a scale
Interval 0.084 to 0.39
|
0.289 Scores on a scale
Interval 0.136 to 0.422
|
0.250 Scores on a scale
Interval 0.101 to 0.399
|
PRIMARY outcome
Timeframe: 24 hours after 2 mg/24 hr patch removalPopulation: FAS
Itching of application site evaluated by the visual analogue scale (VAS) 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment. The score ranges from 0 (no itching) to 100 (strongest imaginable itching).
Outcome measures
| Measure |
Topical Steroid
n=37 Participants
Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
|
Topical Antihistamine
n=38 Participants
Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
|
No-treatment
n=38 Participants
No treatment to the application sites after the patch removal
|
|---|---|---|---|
|
Itching of Application Site Evaluated by the Visual Analogue Scale (VAS)
|
1.6 Scores on a scale
Interval 0.5 to 2.7
|
0.4 Scores on a scale
Interval -0.7 to 1.6
|
0.9 Scores on a scale
Interval -0.2 to 2.0
|
SECONDARY outcome
Timeframe: Up to 72 hours after patch removalPopulation: FAS subjects with a score of ≥ 0.5 (±) at Day 3
Numbers of subjects with each skin irritation score. The scale scoring criteria are 0(-): Negative, 0.5(±): Faint erythema, 1(+): Erythema, 2(++): Erythema + edema, 3(+++): Erythema + edema + papules, serous papule, vesicles, 4(++++): Coalescing vesicles.
Outcome measures
| Measure |
Topical Steroid
n=19 Participants
Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
|
Topical Antihistamine
n=18 Participants
Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
|
No-treatment
n=20 Participants
No treatment to the application sites after the patch removal
|
|---|---|---|---|
|
Skin Irritation Score After Patch Removal
- (1 hour after patch removal)
|
5.3 Percentage of participants
|
5.6 Percentage of participants
|
10.0 Percentage of participants
|
|
Skin Irritation Score After Patch Removal
± (1 hour after patch removal)
|
63.2 Percentage of participants
|
55.6 Percentage of participants
|
45.0 Percentage of participants
|
|
Skin Irritation Score After Patch Removal
+ (1 hour after patch removal)
|
31.6 Percentage of participants
|
38.9 Percentage of participants
|
45.0 Percentage of participants
|
|
Skin Irritation Score After Patch Removal
- (24 hours after patch removal)
|
57.9 Percentage of participants
|
52.6 Percentage of participants
|
60.0 Percentage of participants
|
|
Skin Irritation Score After Patch Removal
± (24 hours after patch removal)
|
36.8 Percentage of participants
|
36.8 Percentage of participants
|
30.0 Percentage of participants
|
|
Skin Irritation Score After Patch Removal
+ (24 hours after patch removal)
|
5.3 Percentage of participants
|
10.5 Percentage of participants
|
10.0 Percentage of participants
|
|
Skin Irritation Score After Patch Removal
- (48 hours after patch removal)
|
89.5 Percentage of participants
|
94.7 Percentage of participants
|
80.0 Percentage of participants
|
|
Skin Irritation Score After Patch Removal
± (48 hours after patch removal)
|
10.5 Percentage of participants
|
5.3 Percentage of participants
|
20.0 Percentage of participants
|
|
Skin Irritation Score After Patch Removal
- (72 hours after patch removal)
|
94.4 Percentage of participants
|
94.7 Percentage of participants
|
90.0 Percentage of participants
|
|
Skin Irritation Score After Patch Removal
± (72 hours after patch removal)
|
5.6 Percentage of participants
|
5.3 Percentage of participants
|
10.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 96 hours after patch removalPopulation: FAS
Changes of itching of application site evaluated by VAS after patch removal (acceleration and dose-escalation periods). The score ranges from 0 (no itching) to 100 (strongest imaginable itching).
Outcome measures
| Measure |
Topical Steroid
n=38 Participants
Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
|
Topical Antihistamine
n=39 Participants
Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
|
No-treatment
n=39 Participants
No treatment to the application sites after the patch removal
|
|---|---|---|---|
|
Itching of Application Site Evaluated by VAS After Patch Removal
96 hours after patch removal
|
-4.3 Scores on a scale
Standard Deviation 10.1
|
-3.8 Scores on a scale
Standard Deviation 8.9
|
-3.0 Scores on a scale
Standard Deviation 5.1
|
|
Itching of Application Site Evaluated by VAS After Patch Removal
3 hours after patch removal
|
-2.8 Scores on a scale
Standard Deviation 6.9
|
-3.0 Scores on a scale
Standard Deviation 9.0
|
-2.2 Scores on a scale
Standard Deviation 4.6
|
|
Itching of Application Site Evaluated by VAS After Patch Removal
6 hours after patch removal
|
-3.3 Scores on a scale
Standard Deviation 7.9
|
-3.3 Scores on a scale
Standard Deviation 8.6
|
-2.3 Scores on a scale
Standard Deviation 5.0
|
|
Itching of Application Site Evaluated by VAS After Patch Removal
24 hours after patch removal
|
-3.9 Scores on a scale
Standard Deviation 10.0
|
-2.6 Scores on a scale
Standard Deviation 7.0
|
-2.6 Scores on a scale
Standard Deviation 4.7
|
|
Itching of Application Site Evaluated by VAS After Patch Removal
48 hours after patch removal
|
-3.9 Scores on a scale
Standard Deviation 10.5
|
-3.6 Scores on a scale
Standard Deviation 9.0
|
-2.9 Scores on a scale
Standard Deviation 5.1
|
|
Itching of Application Site Evaluated by VAS After Patch Removal
72 hours after patch removal
|
-4.1 Scores on a scale
Standard Deviation 10.0
|
-3.8 Scores on a scale
Standard Deviation 8.9
|
-3.0 Scores on a scale
Standard Deviation 5.1
|
Adverse Events
Over-all
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Over-all
n=120 participants at risk
In this study, all the subjects were received SPM962 with the same dose and regimen during the acceleration and dose-escalation periods and then they were randomized into one of the three groups after removal of SPM962 to evaluate recovery of skin reaction caused by SPM962 using either steroids, antihistamine or no treatment.
Since AEs mainly occurred in the acceleration and dose-escalation periods when SPM962 were used, AEs are shown in one group.
|
|---|---|
|
General disorders
Application Site Irritation
|
2.5%
3/120 • Number of events 3 • 7 days
|
|
General disorders
Feeling Hot
|
2.5%
3/120 • Number of events 3 • 7 days
|
|
Nervous system disorders
Headache
|
5.0%
6/120 • Number of events 6 • 7 days
|
|
Psychiatric disorders
Somnolence
|
5.0%
6/120 • Number of events 6 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.0%
6/120 • Number of events 6 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.3%
4/120 • Number of events 4 • 7 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
24.2%
29/120 • Number of events 29 • 7 days
|
Additional Information
Director of Clinical Research and Development
Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7366
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place