Study of OPA-15406 Ointment in Patients With Atopic Dermatitis

• Sponsor: Otsuka Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02914548
• Collaborator: (none)
• Enrollment: 200
• Locations: 3
• Arms: 3
• Actual Duration (Months): 9
• Patients Per Site: 66.7
• Patients Per Site Per Month: 7.4

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy and safety of OPA-15406 ointment in patients with atopic dermatitis.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: OPA-15406; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Assess the Efficacy and Safety of 0.3% and 1% OPA-15406 Ointments in Patients With Atopic Dermatitis
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 0.3% OPA-15406 Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.	Drug: OPA-15406; Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.
Experimental: 1% OPA-15406 Subjects were treated with assigned 1% OPA-15406 ointment twice daily.	Drug: OPA-15406; Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.
Placebo Comparator: Placebo Subjects were treated with assigned 0% OPA-15406 ointment twice daily.	Drug: Placebo; Subjects were treated with assigned 0% OPA-15406 ointment twice daily.

Outcome Measures

Primary Outcome Measures

1. Responder Rate of Investigator's Global Assessment(IGA) of Disease Severity at Week4 [At Week 4]

   The investigator or sub investigator assessed the skin symptoms using IGA. 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 Week4. Incidence of success in IGA was defined as the rate of subjects whose IGA score was 0 (clear) or 1 (almost clear) and had improved by at least 2 grades (responders) from baseline.

Secondary Outcome Measures

1. 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.

2. Change From Baseline in Visual Analogue Scale(VAS) for Pruritus Score [Baseline, Week 4]

   The investigator or subinvestigator evaluated the level of pruritus based on VAS. The subjects will mark the point of pruritus intensity during the last 24 hours on the line of a 100- mm VAS sheet between the left end (no pruritus: the score is 0 ) and the right end (very severe pruritus: the score is 100), and a negative change from the baseline means improvement and a positive change means worsening. Number of participants analyzed represents number of participants with data at both Baseline and Week4. Participants who have no data were excluded

3. Change From Baseline in Verbal Rating Scale(VRS) for Pruritus Score [Baseline, Hour 156]

   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 : Mild : Moderate : 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.

4. Change From Baseline in Patient-Oriented Eczema Measure(POEM) Score [Baseline, Week 4]

   The investigator or sub investigator evaluated eczema according to the POEM. The subjects answered 7 questions about their eczema by 0-4 points per question. The POEMS's minimum and maximum scores are 0 and 28 scores respectively. The higher the POEM score is, the more severe the symptoms are, and a negative change from the baseline means improvement and a positive change means worsening. If it is difficult for subjects to answer the questions, their parents answered them instead. Number of participants analyzed represents number of participants with data at both Baseline and Week4. Participants who have no data were excluded.

5. Change From Baseline in Percentage Affected Body Surface Area [Baseline, Week 4]

   The investigator or subinvestigator drew the affected BSA (range of skin eruption at the time of examination) on the human body drawing to determine the affected areas (%) on the respective 4 body regions (face, neck, and head; upper limbs; trunk; and lower limbs). One palm of the subject corresponds to 1% BSA.

6. Mean (SD) OPA-15406 Plasma Trough Concentrations [Week1, Week4, Week8]

   The plasma concentration of OPA-15406 was measured at Week1, Week4 and Week8. On the day of measurement, the subjects visited the trial site without morning Investigational Medicinal Product (IMP) administration. Number of participants analyzed represents number of participants with data at each point. Participants who have no effective data were excluded.

7. Mean (SD) Normalized OPA-15406 Plasma Trough Concentrations by Dose Derived From %BSA [Week1, Week4, Week8]

   The plasma concentration of OPA-15406 was measured at Week1, Week4 and Week8. On the day of measurement, the subjects visited the trial site without morning Investigational Medicinal Product (IMP) administration.Number of participants analyzed represents number of participants with data at each point. Participants who have no effective data were excluded.

8. OPA-15406 Plasma PK Parameters, Cmax [Day 1 and Week 4]

   OPA-15406 plasma PK parameter (Cmax) was measured on Day 1 and at Week 4 following topical administration of OPA-15406 0.3% and 1% ointment to adult subjects with AD.Number of participants analyzed represents number of participants with effective data at each point. Participants who have no effective data were excluded.

9. OPA-15406 Plasma PK Parameters, AUC8h [Day 1 and Week 4]

   OPA-15406 plasma PK parameter (AUC8h) was measured on Day 1 and at Week 4 following topical administration of OPA-15406 0.3% and 1% ointment to adult subjects with AD.Number of participants analyzed represents number of participants with effective data at each point. Participants who have no effective data were excluded.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka

Exclusion Criteria:

• Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a sudden intensification of atopic dermatitis.

• Subjects who have an active viral skin infection.

• Subjects with a current or history of malignancy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Hokkaido Region		Japan
2		Kanto Region		Japan
3		Kiniki Region		Japan

Sponsors and Collaborators

• Otsuka Pharmaceutical Co., Ltd.

Investigators

• Study Director: Hiroaki Ono, Mr, Otsuka Pharmaceutical Co., Ltd.

Study Documents (Full-Text)

• Study Protocol - Dec 29, 2016
• Statistical Analysis Plan - Aug 18, 2017

More Information

Publications

None provided.

• Responsible Party: Otsuka Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02914548
• Other Study ID Numbers: 271-15-001; JapicCTI-163372
• First Posted: Sep 26, 2016
• Last Update Posted: Jul 23, 2020
• Last Verified: Jun 1, 2020

• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema

Study Results

Participant Flow

Arm/Group Title	0.3% OPA-15406	1% OPA-15406	Placebo
Arm/Group Description	Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 1% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 0% OPA-15406 ointment twice daily. Placebo: Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Period Title: Overall Study
STARTED	67	67	66
COMPLETED	46	53	46
NOT COMPLETED	21	14	20

Baseline Characteristics

Arm/Group Title	0.3% OPA-15406	1% OPA-15406	Placebo	Total
Arm/Group Description	Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 1% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 0% OPA-15406 ointment twice daily. Placebo: Subjects were treated with assigned 0% OPA-15406 ointment twice daily.	Total of all reporting groups
Overall Participants	67	67	66	200
Age (Count of Participants)
<=18 years	2 3%	0 0%	1 1.5%	3 1.5%
Between 18 and 65 years	65 97%	67 100%	65 98.5%	197 98.5%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.2 (9.0)	31.0 (10.8)	31.6 (10.0)	30.9 (9.9)
Sex: Female, Male (Count of Participants)
Female	22 32.8%	25 37.3%	23 34.8%	70 35%
Male	45 67.2%	42 62.7%	43 65.2%	130 65%
Race/Ethnicity, Customized (Count of Participants)
Japanese	67 100%	67 100%	66 100%	200 100%
Region of Enrollment (Count of Participants)
Japan	67 100%	67 100%	66 100%	200 100%

Outcome Measures

1. Primary Outcome

Title	Responder Rate of Investigator's Global Assessment(IGA) of Disease Severity at Week4
Description	The investigator or sub investigator assessed the skin symptoms using IGA. 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 Week4. Incidence of success in IGA was defined as the rate of subjects whose IGA score was 0 (clear) or 1 (almost clear) and had improved by at least 2 grades (responders) from baseline.
Time Frame	At Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0.3% OPA-15406	1% OPA-15406	Placebo
Arm/Group Description	Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 1% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 0% OPA-15406 ointment twice daily. Placebo: Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Measure Participants	67	67	66
Number (95% Confidence Interval) [percentage of participants]	14.93 22.3%	22.39 33.4%	9.09 13.8%

2. Secondary Outcome

Title	Change From Baseline in Eczema Area and Severity Index (EASI) Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0.3% OPA-15406	1% OPA-15406	Placebo
Arm/Group Description	Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 1% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 0% OPA-15406 ointment twice daily. Placebo: Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Measure Participants	57	58	53
Mean (Standard Error) [score on a scale]	-2.32 (0.75)	-3.16 (0.75)	-0.15 (0.77)

3. Secondary Outcome

Title	Change From Baseline in Visual Analogue Scale(VAS) for Pruritus Score
Description	The investigator or subinvestigator evaluated the level of pruritus based on VAS. The subjects will mark the point of pruritus intensity during the last 24 hours on the line of a 100- mm VAS sheet between the left end (no pruritus: the score is 0 ) and the right end (very severe pruritus: the score is 100), and a negative change from the baseline means improvement and a positive change means worsening. 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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0.3% OPA-15406	1% OPA-15406	Placebo
Arm/Group Description	Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 1% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 0% OPA-15406 ointment twice daily. Placebo: Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Measure Participants	57	58	53
Mean (Standard Error) [mm]	-6.76 (3.31)	-6.28 (3.32)	0.90 (3.24)

4. Secondary Outcome

Title	Change From Baseline in Verbal Rating Scale(VRS) for Pruritus Score
Description	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 : Mild : Moderate : 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, Hour 156

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0.3% OPA-15406	1% OPA-15406	Placebo
Arm/Group Description	Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 1% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 0% OPA-15406 ointment twice daily. Placebo: Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Measure Participants	55	54	47
Mean (Standard Error) [score on a scale]	-0.43 (0.10)	-0.49 (0.10)	-0.06 (0.10)

5. Secondary Outcome

Title	Change From Baseline in Patient-Oriented Eczema Measure(POEM) Score
Description	The investigator or sub investigator evaluated eczema according to the POEM. The subjects answered 7 questions about their eczema by 0-4 points per question. The POEMS's minimum and maximum scores are 0 and 28 scores respectively. The higher the POEM score is, the more severe the symptoms are, and a negative change from the baseline means improvement and a positive change means worsening. If it is difficult for subjects to answer the questions, their parents answered them instead. 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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0.3% OPA-15406	1% OPA-15406	Placebo
Arm/Group Description	Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 1% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 0% OPA-15406 ointment twice daily. Placebo: Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Measure Participants	57	58	53
Mean (Standard Error) [score on a scale]	-1.36 (0.77)	-2.90 (0.76)	-0.02 (0.79)

6. Secondary Outcome

Title	Change From Baseline in Percentage Affected Body Surface Area
Description	The investigator or subinvestigator drew the affected BSA (range of skin eruption at the time of examination) on the human body drawing to determine the affected areas (%) on the respective 4 body regions (face, neck, and head; upper limbs; trunk; and lower limbs). One palm of the subject corresponds to 1% BSA.
Time Frame	Baseline, Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0.3% OPA-15406	1% OPA-15406	Placebo
Arm/Group Description	Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 1% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 0% OPA-15406 ointment twice daily. Placebo: Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Measure Participants	57	58	53
Mean (Standard Error) [percentage of Affected Body Surface Area]	-3.94 (1.44)	-3.73 (1.43)	-0.32 (1.48)

7. Secondary Outcome

Title	Mean (SD) OPA-15406 Plasma Trough Concentrations
Description	The plasma concentration of OPA-15406 was measured at Week1, Week4 and Week8. On the day of measurement, the subjects visited the trial site without morning Investigational Medicinal Product (IMP) administration. Number of participants analyzed represents number of participants with data at each point. Participants who have no effective data were excluded.
Time Frame	Week1, Week4, Week8

Outcome Measure Data

Analysis Population Description

All subjects who had received the IMP at least once and whose plasma drug concentration had been measured

Arm/Group Title	0.3% OPA-15406	1% OPA-15406
Arm/Group Description	Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 1% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.
Measure Participants	64	62
Week 1	1.74 (1.87)	4.96 (5.04)
Week 4	1.71 (2.50)	5.22 (4.70)
Week 8	1.51 (1.77)	5.52 (8.28)

8. Secondary Outcome

Title	Mean (SD) Normalized OPA-15406 Plasma Trough Concentrations by Dose Derived From %BSA
Description	The plasma concentration of OPA-15406 was measured at Week1, Week4 and Week8. On the day of measurement, the subjects visited the trial site without morning Investigational Medicinal Product (IMP) administration.Number of participants analyzed represents number of participants with data at each point. Participants who have no effective data were excluded.
Time Frame	Week1, Week4, Week8

Outcome Measure Data

Analysis Population Description

All subjects who had received the IMP at least once and whose plasma drug concentration had been measured

Arm/Group Title	0.3% OPA-15406	1% OPA-15406
Arm/Group Description	Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 1% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.
Measure Participants	64	62
Week 1	0.114 (0.0991)	0.113 (0.0952)
Week 4	0.104 (0.119)	0.127 (0.119)
Week 8	0.0910 (0.103)	0.137 (0.242)

9. Secondary Outcome

Title	OPA-15406 Plasma PK Parameters, Cmax
Description	OPA-15406 plasma PK parameter (Cmax) was measured on Day 1 and at Week 4 following topical administration of OPA-15406 0.3% and 1% ointment to adult subjects with AD.Number of participants analyzed represents number of participants with effective data at each point. Participants who have no effective data were excluded.
Time Frame	Day 1 and Week 4

Outcome Measure Data

Analysis Population Description

All subjects who had received the IMP at least once and whose plasma drug concentration had been measured

Arm/Group Title	0.3% OPA-15406	1% OPA-15406
Arm/Group Description	Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 1% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.
Measure Participants	11	9
Day 1	4.01 (5.90)	7.27 (6.42)
Week 4	2.07 (1.47)	10.4 (3.68)

10. Secondary Outcome

Title	OPA-15406 Plasma PK Parameters, AUC8h
Description	OPA-15406 plasma PK parameter (AUC8h) was measured on Day 1 and at Week 4 following topical administration of OPA-15406 0.3% and 1% ointment to adult subjects with AD.Number of participants analyzed represents number of participants with effective data at each point. Participants who have no effective data were excluded.
Time Frame	Day 1 and Week 4

Outcome Measure Data

Analysis Population Description

All subjects who had received the IMP at least once and whose plasma drug concentration had been measured

Arm/Group Title	0.3% OPA-15406	1% OPA-15406
Arm/Group Description	Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.	Subjects were treated with assigned 1% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.
Measure Participants	11	9
Day 1	22.0 (34.7)	41.6 (37.6)
Week 4	11.6 (7.23)	65.2 (26.8)

Adverse Events

Time Frame	Treatment period (8 weeks)
Arm/Group Title	0.3% OPA-15406		1% OPA-15406		Placebo
Arm/Group Description	Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.		Subjects were treated with assigned 1% OPA-15406 ointment twice daily. OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.		Subjects were treated with assigned 0% OPA-15406 ointment twice daily. Placebo: Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
All Cause Mortality
	0.3% OPA-15406		1% OPA-15406		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		0/67 (0%)		0/66 (0%)
Serious Adverse Events
	0.3% OPA-15406		1% OPA-15406		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		0/67 (0%)		0/66 (0%)
Other (Not Including Serious) Adverse Events
	0.3% OPA-15406		1% OPA-15406		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/67 (32.8%)		11/67 (16.4%)		20/66 (30.3%)
Infections and infestations
Viral upper respiratory tract infection	7/67 (10.4%)		4/67 (6%)		7/66 (10.6%)
Skin and subcutaneous tissue disorders
Dermatitis atopic	11/67 (16.4%)		6/67 (9%)		12/66 (18.2%)
Pruritus	5/67 (7.5%)		1/67 (1.5%)		4/66 (6.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.