Atopic Dermatitis
Conditions
Brief summary
To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in pediatric patients with Atopic Dermatitis (AD).
Interventions
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of AD based on the Japanese Dermatological Association's criteria * Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of body surface area (BSA, excluding scalp) at the screening and baseline examinations * IGA score of 2 or 3 at the screening and baseline examinations
Exclusion criteria
* Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate of Investigator's Global Assesment (IGA) of Disease Severity | At Week 4 | The investigator or subinvestigator assessed the skin symptoms using IGA. The investigator or subinvestigator 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 is defined as the rate of subjects whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Eczema Area and Severity Index (EASI) Score | Baseline, Week 4 | The investigator or sub investigator assessed the symptoms of AD using EASI. EASI's minimum and maximum scores are 0 and 72 scores respectively. The higher the EASI score is, the more severe the symptoms of AD, and a negative change from the baseline means improvement and a positive change means worsening. The investigator or sub investigator scored the severity (0-3 points) and affected BSA (%) based on the 4 symptoms (erythema, infiltration/papules, excoriation, and lichenification) on the 4 body regions (face, neck and head ; upper limbs ;trunk; and lower limbs). Number of participants analyzed represents number of participants with data at both Baseline and Week4. Participants who have no data were excluded. |
| Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score | Baseline, Week 4 | The investigator or subinvestigator evaluated the pruritus intensity based on VRS. The subjects aged 7 to 14 years old evaluated the pruritus intensity according to the following criteria. The subjects recorded the level of pruritus and the time and date of evaluation in a pruritus diary. 0 : None 1. : Mild 2. : Moderate 3. : Severe For subjects aged 2 to 6 years, this would not be evaluated. Number of participants analyzed represents number of participants with data at both Baseline and Week4. Participants who have no data were excluded. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.3% OPA-15406 Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. | 83 |
| 1% OPA-15406 Subjects were treated with assigned 1% OPA-15406 ointment twice daily. | 85 |
| Placebo Subjects were treated with assigned 0% OPA-15406 ointment twice daily. | 83 |
| Total | 251 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 5 |
| Overall Study | Lack of Efficacy | 1 | 1 | 8 |
| Overall Study | Physician Decision | 0 | 0 | 1 |
| Overall Study | Withdrawal by parent/guardian | 4 | 4 | 11 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | 0.3% OPA-15406 | 1% OPA-15406 | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 7.1 years STANDARD_DEVIATION 3.3 | 7.2 years STANDARD_DEVIATION 3.2 | 7.1 years STANDARD_DEVIATION 2.8 | 7.1 years STANDARD_DEVIATION 3.1 |
| Race/Ethnicity, Customized Asian | 83 Participants | 85 Participants | 83 Participants | 251 Participants |
| Region of Enrollment Japan | 83 Participants | 85 Participants | 83 Participants | 251 Participants |
| Sex: Female, Male Female | 45 Participants | 37 Participants | 34 Participants | 116 Participants |
| Sex: Female, Male Male | 38 Participants | 48 Participants | 49 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 83 | 0 / 85 | 0 / 83 |
| other Total, other adverse events | 11 / 83 | 9 / 85 | 7 / 83 |
| serious Total, serious adverse events | 0 / 83 | 0 / 85 | 0 / 83 |
Outcome results
Primary
Responder Rate of Investigator's Global Assesment (IGA) of Disease Severity
The investigator or subinvestigator assessed the skin symptoms using IGA. The investigator or subinvestigator 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 is defined as the rate of subjects whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline.
Time frame: At Week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0.3% OPA-15406 | Responder Rate of Investigator's Global Assesment (IGA) of Disease Severity | 44.58 percentage of participants |
| 1% OPA-15406 | Responder Rate of Investigator's Global Assesment (IGA) of Disease Severity | 47.06 percentage of participants |
| Placebo | Responder Rate of Investigator's Global Assesment (IGA) of Disease Severity | 18.07 percentage of participants |
Secondary
Change From Baseline in Eczema Area and Severity Index (EASI) Score
The investigator or sub investigator assessed the symptoms of AD using EASI. EASI's minimum and maximum scores are 0 and 72 scores respectively. The higher the EASI score is, the more severe the symptoms of AD, and a negative change from the baseline means improvement and a positive change means worsening. The investigator or sub investigator scored the severity (0-3 points) and affected BSA (%) based on the 4 symptoms (erythema, infiltration/papules, excoriation, and lichenification) on the 4 body regions (face, neck and head ; upper limbs ;trunk; and lower limbs). Number of participants analyzed represents number of participants with data at both Baseline and Week4. Participants who have no data were excluded.
Time frame: Baseline, Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.3% OPA-15406 | Change From Baseline in Eczema Area and Severity Index (EASI) Score | -4.97 score on a scale | Standard Error 0.84 |
| 1% OPA-15406 | Change From Baseline in Eczema Area and Severity Index (EASI) Score | -6.07 score on a scale | Standard Error 0.84 |
| Placebo | Change From Baseline in Eczema Area and Severity Index (EASI) Score | 0.35 score on a scale | Standard Error 0.9 |
Secondary
Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score
The investigator or subinvestigator evaluated the pruritus intensity based on VRS. The subjects aged 7 to 14 years old evaluated the pruritus intensity according to the following criteria. The subjects recorded the level of pruritus and the time and date of evaluation in a pruritus diary. 0 : None 1. : Mild 2. : Moderate 3. : Severe For subjects aged 2 to 6 years, this would not be evaluated. Number of participants analyzed represents number of participants with data at both Baseline and Week4. Participants who have no data were excluded.
Time frame: Baseline, Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.3% OPA-15406 | Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score | -0.80 score on a scale | Standard Error 0.12 |
| 1% OPA-15406 | Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score | -0.68 score on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score | -0.33 score on a scale | Standard Error 0.13 |