Atopic DermatitisPhase 3NCT05608343
This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)
A Phase 3 study testing Difamilast in people with Atopic Dermatitis, run by Acrotech Biopharma Inc. at 39 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Difamilast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 39 sitesUnited States
- Study dates
- 1 Oct 2022to 27 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Important Inclusion Criteria:
- Subjects who are male or female ≥2 years of age
- 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.
- Subjects who have a diagnosis of AD based on the American Academy of Dermatology AD diagnostic criteria
- Subjects who have had a diagnosis of AD for at least 6 months prior to Screening visit
- Subjects who have AD involvement ≥5% to ≤40% of treatable Body Surface Area (BSA) excluding scalp
- 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:
- 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
- Subjects who have evidence of spontaneous clearance of AD between screening and baseline visits
- 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
- Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, and chicken pox) and/or clinically infected AD
- Subject with greater than mild depression and suicidal ideation prior to screening or between screening and baseline visits
- Subjects who have a known history of alcohol abuse or illicit drugs within 6 months prior to screening
Etc.,
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Arlington Research Center, Inc.
Arlington, Texas, 76011
Oakland Hills Dermatology, PC
Auburn Hills, Michigan, 48326
Bexley Dermatology Research
Bexley, Ohio, 43209
AllerVie Health
Birmingham, Alabama, 35244
Optima Research
Boardman, Ohio, 44512
TrueBlue Clinical Research
Brandon, Florida, 33511
Metro Boston Clinical Partners
Brighton, Massachusetts, 02135
IMMUNOe Research Centers
Centennial, Colorado, 80112
DS Research
Clarksville, Indiana, 47129
Remington-Davis, Inc.
Columbus, Ohio, 43215
Avant Research Associates, LLC
Crowley, Louisiana, 70526
Accel Research - Edgewater Clinical Research Unit
Edgewater, Florida, 32132
First OC Dermatology
Fountain Valley, California, 92708
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
North Texas Center for Clinical Research
Frisco, Texas, 75034
Dermatology Consulting Services, PLLC
High Point, North Carolina, 27262
Center for Clinical Studies, Ltd, LLP
Houston, Texas, 77004
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
NEA Baptist Clinic-Dermatology
Jonesboro, Arkansas, 72405
Antelope Valley Clinical Trials
Lancaster, California, 93534
Dermatology Research Associates
Los Angeles, California, 90045
DS Research
Louisville, Kentucky, 40241
Clinical Trials Management, LLC
Metairie, Louisiana, 70006
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, 37130
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Tory Sullivan, MD PA
North Miami Beach, Florida, 33162
Nona Pediatrics
Orlando, Florida, 32829
Accel Research - Ormond Clinical Research Unit
Ormond Beach, Florida, 32174
Elite Clinical Studies, LLC
Phoenix, Arizona, 85018
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
DermAssociates, LLC
Rockville, Maryland, 20850
Arlington Dermatology
Rolling Meadows, Illinois, 60008
Shahram Jacobs, MD Inc.
Sherman Oaks, California, 91403
South Bend Clinic
South Bend, Indiana, 46617
Premier Clinical Research, LLC
Spokane, Washington, 99202
Olympian Clinical Research
St. Petersburg, Florida, 33706
Houston Center for Clinical Research
Sugar Land, Texas, 77479
Clinical Trials Research Institute
Thousand Oaks, California, 91320
Peak Research, LLC
Upper Saint Clair, Pennsylvania, 15241
About this study
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
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Difamilast, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DifamilastDrug
Off-white ointment containing active ingredient, petrolatum and other ingredients
PlaceboDrug
Matching Difamilast (Study drug) ointment without active ingradient
| Study group | Role | What they receive |
|---|---|---|
| Difamilast Ointment | Active comparator | 1% Difamilast Ointment Receives: Drug: Difamilast |
| Vehicle Controlled | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
The proportion of subjects achieving success on the the 5-point Investigator Global Assessment (IGA) of AD Severity score at Day 29, and the success is defined as as a score of Clear (0) or Almost clear (1), with at least a 2-grade improvement from Baseline on the 5-point IGA of AD Severity score at Day 29
Measured: Baseline, Day 29
Secondary outcomes (1)
To further characterize the efficacy of Difamilast ointment 1% compared to vehicle control in subjects with mild to moderate AD
The proportion of subjects achieving an IGA of AD Severity score of Clear (0) or Almost clear (1) at Day 29; the proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 22; the proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 15 The proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 22 The proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 15
Measured: Baseline, Day 15, Day 22 and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Oct 2022
- Primary completion27 Oct 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acrotech Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uma Srinivas Atmuri, MPharm MS, Study director, Acrotech Biopharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608343
- Sponsor's protocol ID
- MM36-301
- Status last verified
- Aug 2024
- First submitted
- 1 Nov 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05608343
- Acronym / sponsor ID
- MM36-301
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Acrotech Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Difamilast Ointment | Active comparator | Drug: Difamilast1% Difamilast Ointment |
| Vehicle Controlled | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DifamilastOff-white ointment containing active ingredient, petrolatum and other ingredients | Drug | Difamilast Ointment |
| PlaceboMatching Difamilast (Study drug) ointment without active ingradient | Drug | Vehicle Controlled |
Primary outcome
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
Time frame: Baseline, Day 29
The proportion of subjects achieving success on the the 5-point Investigator Global Assessment (IGA) of AD Severity score at Day 29, and the success is defined as as a score of Clear (0) or Almost clear (1), with at least a 2-grade improvement from Baseline on the 5-point IGA of AD Severity score at Day 29
1 secondary outcome
To further characterize the efficacy of Difamilast ointment 1% compared to vehicle control in subjects with mild to moderate AD
Time frame: Baseline, Day 15, Day 22 and Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uma Srinivas Atmuri, MPharm MS study director
Acrotech Biopharma Inc.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Difamilast in people with Atopic Dermatitis, run by Acrotech Biopharma Inc. at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline, Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.