Clinical trial NCT05608343: This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)
Official title: A Phase 3, Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Difamilast Ointment 1% in Children, Adolescents, and Adults With Mild to Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Acrotech Biopharma Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-08
Enrollment: 153
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a Phase 3 Double Blind multi-center study conducted at 40 investigational sites in United States to assess the efficacy and safety of Difamilast Ointment 1% in subjects ≥2 years of age with mild to moderate atopic dermatitis.


Eligibility criteria: Important Inclusion Criteria:

1. Subjects who are male or female ≥2 years of age
2. Subjects and/or their parent(s)/legal guardian(s) (if subject is under the legal age of consent) provide written informed consent in accordance with federal and/or local laws prior to the conduct of any study-related procedures.
3. Subjects who have a diagnosis of AD based on the American Academy of Dermatology AD diagnostic criteria
4. Subjects who have had a diagnosis of AD for at least 6 months prior to Screening visit
5. Subjects who have AD involvement ≥5% to ≤40% of treatable Body Surface Area (BSA) excluding scalp
6. Subjects who have an AD Severity of mild (2) or moderate (3) as measured by the IGA of AD Severity score at screening and baseline visit

Important Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding or who plan to become pregnant during the study and through 90 days after the last dose of study drug
2. Subjects who have evidence of spontaneous clearance of AD between screening and baseline visits
3. Subjects who have a history of unstable AD as assessed by the Investigator. Unstable AD is defined as disease flares occurring within 4 weeks prior to baseline visit
4. Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, and chicken pox) and/or clinically infected AD
5. Subject with greater than mild depression and suicidal ideation prior to screening or between screening and baseline visits
6. Subjects who have a known history of alcohol abuse or illicit drugs within 6 months prior to screening

Etc.,

Primary outcomes:
measure: To evaluate the efficacy of twice-daily topical application of Difamilast ointment 1% compared to vehicle control in subjects ≥2 years of age with mild to moderate AD
timeFrame: Baseline, Day 29
Secondary outcomes:
measure: To further characterize the efficacy of Difamilast ointment 1% compared to vehicle control in subjects with mild to moderate AD
timeFrame: Baseline, Day 15, Day 22 and Day 29
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: AllerVie Health
state: Alabama
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC
state: Arizona
city: Jonesboro
country: United States
facility: NEA Baptist Clinic-Dermatology
state: Arkansas
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Lancaster
country: United States
facility: Antelope Valley Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Sherman Oaks
country: United States
facility: Shahram Jacobs, MD Inc.
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Research Institute
state: California
city: Centennial
country: United States
facility: IMMUNOe Research Centers
state: Colorado
city: Brandon
country: United States
facility: TrueBlue Clinical Research
state: Florida
city: Edgewater
country: United States
facility: Accel Research - Edgewater Clinical Research Unit
state: Florida
city: North Miami Beach
country: United States
facility: Tory Sullivan, MD PA
state: Florida
city: Orlando
country: United States
facility: Nona Pediatrics
state: Florida
city: Ormond Beach
country: United States
facility: Accel Research - Ormond Clinical Research Unit
state: Florida
city: Saint Petersburg
country: United States
facility: Olympian Clinical Research
state: Florida
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: Clarksville
country: United States
facility: DS Research
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: Crowley
country: United States
facility: Avant Research Associates, LLC
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: Rockville
country: United States
facility: DermAssociates, LLC
state: Maryland
city: Brighton
country: United States
facility: Metro Boston Clinical Partners
state: Massachusetts
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology, PC
state: Michigan
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: High Point
country: United States
facility: Dermatology Consulting Services, PLLC
state: North Carolina
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
city: Boardman
country: United States
facility: Optima Research
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis, Inc.
state: Ohio
city: Upper Saint Clair
country: United States
facility: Peak Research, LLC
state: Pennsylvania
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee LLC
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Frisco
country: United States
facility: North Texas Center for Clinical Research
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies, Ltd, LLP
state: Texas
city: Sugar Land
country: United States
facility: Houston Center for Clinical Research
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research, LLC
state: Washington
Study officials:
affiliation: Acrotech Biopharma Inc.
name: Uma Srinivas Atmuri, MPharm MS
role: STUDY_DIRECTOR
References: