Trial Outcomes & Findings for A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis (NCT NCT05372653)
NCT ID: NCT05372653
Last Updated: 2025-03-30
Results Overview
The investigator or sub investigator assessed the skin symptoms using IGA (Investigator's Global Assessment). The investigator or sub investigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe/very severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week 4. Incidence of success in IGA was defined as the rate of subjects whose IGA score is 0 (clear) or 1 (almost clear) and had improved by at least 2 grades (responders) from baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
41 participants
Primary outcome timeframe
Week 4
Results posted on
2025-03-30
Participant Flow
Participant milestones
| Measure |
0.3% OPA-15406
The 0.3% formulation was topically administered twice daily (approximately 12 hours apart between morning and night administrations) for 52 weeks.
|
1% OPA-15406
As the starting dose, the 0.3% formulation was topically administered twice daily (approximately 12 hours apart between morning and night administrations) . After 4 weeks of the IMP administration, the 1% formulation was administered twice daily in accordance with the prespecified rules for dose increase.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
29
|
|
Overall Study
COMPLETED
|
11
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
0.3% OPA-15406
The 0.3% formulation was topically administered twice daily (approximately 12 hours apart between morning and night administrations) for 52 weeks.
|
1% OPA-15406
As the starting dose, the 0.3% formulation was topically administered twice daily (approximately 12 hours apart between morning and night administrations) . After 4 weeks of the IMP administration, the 1% formulation was administered twice daily in accordance with the prespecified rules for dose increase.
|
|---|---|---|
|
Overall Study
Study treatment terminated by parent/guardian
|
1
|
3
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
0.3% OPA-15406
n=12 Participants
The 0.3% formulation was topically administered twice daily (approximately 12 hours apart between morning and night administrations) for 52 weeks.
|
1% OPA-15406
n=29 Participants
As the starting dose, the 0.3% formulation was topically administered twice daily (approximately 12 hours apart between morning and night administrations) . After 4 weeks of the IMP administration, the 1% formulation was administered twice daily in accordance with the prespecified rules for dose increase.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.9 Months
STANDARD_DEVIATION 3.9 • n=93 Participants
|
10.8 Months
STANDARD_DEVIATION 5.4 • n=4 Participants
|
10.0 Months
STANDARD_DEVIATION 5.1 • n=27 Participants
|
|
Age, Customized
Age Group · <12 months
|
10 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Age, Customized
Age Group · >=12 months
|
2 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
12 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Region of Enrollment
Japan
|
12 participants
n=93 Participants
|
29 participants
n=4 Participants
|
41 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: The efficacy analysis set (FAS \[full analysis set\]) consisted of all subjects who received the IMP at least once.
The investigator or sub investigator assessed the skin symptoms using IGA (Investigator's Global Assessment). The investigator or sub investigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe/very severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week 4. Incidence of success in IGA was defined as the rate of subjects whose IGA score is 0 (clear) or 1 (almost clear) and had improved by at least 2 grades (responders) from baseline.
Outcome measures
| Measure |
0.3% OPA-15406
n=41 Participants
|
|---|---|
|
Success Rate in IGA (Percentage of Subjects With an IGA Score of 0 or 1 With Improvement by at Least 2 Grades)
|
56.10 Percentage of perticipants
Interval 39.75 to 71.53
|
SECONDARY outcome
Timeframe: Week4Population: The efficacy analysis set (FAS \[full analysis set\]) consisted of all subjects who received the IMP at least once.
Response (improvement) in EASI 75 was defined as a decrease by ≥75% in the percent change from baseline in the total score of EASI.
Outcome measures
| Measure |
0.3% OPA-15406
n=41 Participants
|
|---|---|
|
Response Rate in Eczema Area and Severity Index (EASI) 75 (Improvement of ≥75% in EASI)
|
82.93 Percentage of perticipants
Interval 67.94 to 92.85
|
Adverse Events
0.3% OPA-15406
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
1% OPA-15406
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.3% OPA-15406
n=41 participants at risk
The 0.3% formulation was topically administered twice daily (approximately 12 hours apart between morning and night administrations) .
In this section, we display the adverse events that occurred at the time of administration of the 0.3% formulation.
|
1% OPA-15406
n=29 participants at risk
After 4 weeks of the 0.3% formulation administration, the 1% formulation was administered twice daily in accordance with the prespecified rules for dose increase.
In this section, we display the adverse events that occurred at the time of administration of the 1.0% formulation.
|
|---|---|---|
|
Vascular disorders
Kawasaki's disease
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
3.4%
1/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
2.4%
1/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
0.00%
0/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
Other adverse events
| Measure |
0.3% OPA-15406
n=41 participants at risk
The 0.3% formulation was topically administered twice daily (approximately 12 hours apart between morning and night administrations) .
In this section, we display the adverse events that occurred at the time of administration of the 0.3% formulation.
|
1% OPA-15406
n=29 participants at risk
After 4 weeks of the 0.3% formulation administration, the 1% formulation was administered twice daily in accordance with the prespecified rules for dose increase.
In this section, we display the adverse events that occurred at the time of administration of the 1.0% formulation.
|
|---|---|---|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
6.9%
2/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
13.8%
4/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
6.9%
2/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
General disorders
Pyrexia
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
10.3%
3/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
10.3%
3/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
6.9%
2/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
6.9%
2/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
17.2%
5/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Gastroenteritis
|
9.8%
4/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
55.2%
16/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
6.9%
2/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
17.2%
5/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Herpangina
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
13.8%
4/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Impetigo
|
7.3%
3/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
10.3%
3/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Influenza
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
6.9%
2/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Nasopharyngitis
|
43.9%
18/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
82.8%
24/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Otitis media
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
6.9%
2/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
27.6%
8/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
13.8%
4/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
6.9%
2/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Skin candida
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
10.3%
3/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
6.9%
2/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
7.3%
3/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
6.9%
2/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
20.7%
6/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
6.9%
2/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Infections and infestations
COVID-19
|
9.8%
4/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
24.1%
7/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
13.8%
4/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
6.9%
2/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
6.9%
2/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
10.3%
3/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
6.9%
2/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
6.9%
2/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
6.9%
2/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
10.3%
3/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
10.3%
3/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
13.8%
4/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
19.5%
8/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
27.6%
8/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
34.5%
10/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
12.2%
5/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
13.8%
4/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
6.9%
2/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/41 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
13.8%
4/29 • Adverse event collection begins after a legal guardian signs the ICF, and continues until the completion of the 52-week follow-up examination (or the final observation day).
The safety analysis set (SS) consisted of all subjects who received the IMP at least once. The groups were described separately to identify adverse events that occurred in the subjects who had received only the 0.3% formulation and those that occurred in the subjects who had received the 1% formulation at least once.
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., Ltd.
Phone: +81363617366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place