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Phosphodiesterase-4 (PDE-4) Inhibitor
Difamilast Ointment for Atopic Dermatitis
Phase 3
Waitlist Available
Research Sponsored by Acrotech Biopharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 15, day 22 and day 29
Awards & highlights
Pivotal Trial
Summary
This trial tests a medicated cream called Difamilast Ointment on people aged 2 and older who have mild to moderate atopic dermatitis. The cream aims to reduce skin inflammation and itching.
Eligible Conditions
- Atopic Dermatitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 15, day 22 and day 29
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 15, day 22 and day 29
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Secondary study objectives
To further characterize the efficacy of Difamilast ointment 1% compared to vehicle control in subjects with mild to moderate AD
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Difamilast OintmentActive Control1 Intervention
1% Difamilast Ointment
Group II: Vehicle ControlledPlacebo Group1 Intervention
Matching placebo
Who is running the clinical trial?
Acrotech Biopharma Inc.Lead Sponsor
30 Previous Clinical Trials
4,885 Total Patients Enrolled
Uma Srinivas Atmuri, MPharm MSStudy DirectorAcrotech Biopharma Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with atopic dermatitis (AD) based on the diagnostic criteria of the American Academy of Dermatology.You are male or female at least 2 years of age.You currently have a skin infection or an active rash from conditions like herpes or chickenpox.Subjects and/or their parent(s)/legal guardian(s) (if subject is under the legal age of consent) must provide written informed consent prior to the conduct of any study-related procedures.You have a skin condition called AD that affects between 5% to 40% of your body, excluding your 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.Your atopic dermatitis (AD) has improved on its own between the screening and baseline visits.You have serious feelings of sadness and thoughts of hurting yourself before or during the study.You have been diagnosed with Alzheimer's disease at least 6 months before the screening visit.You have a history of heavy drinking or using illegal drugs in the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Difamilast Ointment
- Group 2: Vehicle Controlled
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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