Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

A Multicenter, Open-label, Uncontrolled, Long-term Trialto Demonstrate the Safety and Efficacy of 1% OPA-15406 Ointment in Adult Patients With Atopic Dermatitis and of 0.3% and 1% OPA-15406 Ointments in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03961529
• Other study ID #: 271-102-00006
• Status: Completed
• Phase: Phase 3
• Start date: May 14, 2019
• Est. completion date: November 11, 2020

Study information

• Verified date: October 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and 1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: November 11, 2020
• Est. primary completion date: November 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• Age: At least 2 years (at time of obtaining informed consent)

• Diagnosis of AD based on the Japanese Dermatological Association's criteria

• Atopic dermatitis affecting =5% of body surface area (BSA, excluding scalp) 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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• 0.3% OPA-15406 ointment
Twice daily
• 1% OPA-15406 ointment
Twice daily

Locations

Country	Name	City	State
Japan	Shirao clinic of pediatrics and pediatric allergy	Hiroshima

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)	The number of subjects were calculated regarding adverse events occurring after IMP administration (=TEAEs).	Treatment period (52 weeks)
Secondary	Responder Rate of Investigator's Global Assessment (IGA)	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 52.; 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.	Week 52
Secondary	Responder Rate of Eczema Area and Severity Index 75 (EASI 75)	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. The investigator or sub investigator scored the severity (0-3 points) and affected body surface area (%) 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).; EASI 75 is defined as the rate of subjects whose EASI score has improved at least 75% from baseline.	Week 52