MedPath

Difamilast

Generic Name
Difamilast
Drug Type
Small Molecule
Chemical Formula
C23H24F2N2O5
CAS Number
937782-05-3
Unique Ingredient Identifier
T3U32GLJ0F
Background

Difamilast is under investigation in clinical trial NCT01702181 (A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis).

This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)

Phase 3
Completed
Conditions
Atopic Dermatitis
Interventions
Drug: Placebo
First Posted Date
2022-11-08
Last Posted Date
2024-08-15
Lead Sponsor
Acrotech Biopharma Inc.
Target Recruit Count
153
Registration Number
NCT05608343
Locations
🇺🇸

Nona Pediatrics, Orlando, Florida, United States

🇺🇸

Tory Sullivan, MD PA, North Miami Beach, Florida, United States

🇺🇸

Avant Research Associates, LLC, Crowley, Louisiana, United States

and more 35 locations

A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis

Phase 3
Completed
Conditions
Atopic Dermatitis
Interventions
First Posted Date
2022-10-07
Last Posted Date
2024-08-09
Lead Sponsor
Acrotech Biopharma Inc.
Target Recruit Count
542
Registration Number
NCT05571943
Locations
🇺🇸

Qualmedica Research, LLC, Bowling Green, Kentucky, United States

🇺🇸

Antelope Valley Clinical Trials, Lancaster, California, United States

🇺🇸

Dermatology Research Associates, Los Angeles, California, United States

and more 56 locations

A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis

Phase 3
Completed
Conditions
Atopic Dermatitis (AD)
Interventions
First Posted Date
2022-05-13
Last Posted Date
2025-03-30
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
41
Registration Number
NCT05372653
Locations
🇯🇵

Sotobo Children's Clinic, Isumi, Japan

Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis

Phase 2
Completed
Conditions
Atopic Dermatitis
Interventions
Drug: Placebos
First Posted Date
2017-01-12
Last Posted Date
2020-07-23
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
73
Registration Number
NCT03018691

Study of OPA-15406 Ointment in Patients With Atopic Dermatitis

Phase 2
Completed
Conditions
Atopic Dermatitis
Interventions
Drug: Placebo
First Posted Date
2016-09-26
Last Posted Date
2020-07-23
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
200
Registration Number
NCT02914548

A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis

Phase 2
Completed
Conditions
Atopic Dermatitis
Interventions
Drug: Vehicle ointment
First Posted Date
2014-02-21
Last Posted Date
2021-11-23
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
121
Registration Number
NCT02068352

A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis

Phase 1
Completed
Conditions
Atopic Dermatitis
Interventions
First Posted Date
2012-10-05
Last Posted Date
2014-01-17
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
92
Registration Number
NCT01702181
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