A Phase 3 interventional study of 1% OPA-15406 and Placebos in Atopic Dermatitis, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 15 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-01-25.
Sponsored by Otsuka Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
To demonstrate the superiority of IMP (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 adult patients with AD.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 364 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Twice daily
Drug: 1% OPA-15406
Twice daily
Drug: Placebos
Twice daily
Twice daily
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
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).
Time frame: Baseline, Week 4
Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score
The investigator or subinvestigator evaluated the pruritus intensity based on VRS. The subjects 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
Time frame: Baseline, Week 4
| Milestone | 1% OPA-15406 | Placebo |
|---|---|---|
| Started | 182 | 182 |
| Completed | 165 | 135 |
| Not completed | 17 | 47 |
| Withdrew: Adverse event | 7 | 21 |
| Withdrew: Physician decision | 1 | 4 |
| Withdrew: Withdrawal by subject | 9 | 22 |
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.
| percentage of perticipants | 1% OPA-15406 | Placebo |
|---|---|---|
| Responder Rate of Investigator's Global Assesment(IGA) of Disease Severity | 38.46 (31.36 to 45.95) | 12.64 (8.18 to 18.36) |
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).
| score on a scale | 1% OPA-15406 | Placebo |
|---|---|---|
| Change From Baseline in Eczema Area and Severity Index (EASI) Score | -4.17 ± 0.50 | -0.08 ± 0.52 |
The investigator or subinvestigator evaluated the pruritus intensity based on VRS. The subjects 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
| score on a scale | 1% OPA-15406 | Placebo |
|---|---|---|
| Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score | -0.65 ± 0.06 | -0.04 ± 0.07 |
Collected over Treatment period (4 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1% OPA-15406 | 0/182 (0%) | 0/182 (0%) | 7/182 (3.8%) |
| Placebo | 0/182 (0%) | 0/182 (0%) | 22/182 (12.1%) |
| Event | 1% OPA-15406 | Placebo |
|---|---|---|
| Dermatitis atopicSkin and subcutaneous tissue disorders | 7/182 | 22/182 |
| Age, Continuous(years) | 1% OPA-15406 | Placebo | Total |
|---|---|---|---|
| Mean | 31.7 ± 10.9 | 32.1 ± 10.6 | 31.9 ± 10.7 |
| Sex: Female, Male(Participants) | 1% OPA-15406 | Placebo | Total |
|---|---|---|---|
| Female | 86 | 81 | 167 |
| Male | 96 | 101 | 197 |
| Race/Ethnicity, Customized(Participants) | 1% OPA-15406 | Placebo | Total |
|---|---|---|---|
| Asian | 182 | 182 | 364 |
| Region of Enrollment(Participants) | 1% OPA-15406 | Placebo | Total |
|---|---|---|---|
| Japan | 182 | 182 | 364 |
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Otsuka Pharmaceutical Co., Ltd.