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Phosphodiesterase-4 (PDE-4) Inhibitor
Crisaborole for Eczema (PAD Trial)
Phase 4
Waitlist Available
Led By Kevin C Thomas, PhD
Research Sponsored by Boston University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have an Investigator's Static Global Assessment (ISGA) score of Mild (2) or Moderate (3) at the baseline visit
Have AD involvement ≥ 5% Treatable % Body Surface Area (BSA) excluding the scalp and less than 40% BSA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights
PAD Trial Summary
This trial will help assess how well a new medication, Crisaborole, works in comparison to the standard treatment for reducing itch and night-time scratch in children with atopic dermatitis.
Who is the study for?
Children aged 3 months to 11 years with mild to moderate atopic dermatitis (AD) and their caregivers can join this study. Participants must have AD on more than 5% but less than 40% of their body, excluding the scalp. They should not use other skin treatments in affected areas and need a minimum itch score. Caregivers must be healthy adults without AD.Check my eligibility
What is being tested?
The trial is testing Crisaborole ointment against a non-medicated vehicle treatment for reducing nighttime itching and improving sleep in children with AD. It also examines how these changes affect the quality of life and sleep of caregivers using wearable accelerometry devices.See study design
What are the potential side effects?
Crisaborole may cause side effects like burning or stinging at the application site, worsening skin infections, allergic reactions, or hives. The severity varies from person to person.
PAD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My skin condition is rated as mild or moderate by my doctor.
Select...
My skin condition affects more than 5% but less than 40% of my body, not including my scalp.
Select...
I have been diagnosed with atopic dermatitis.
Select...
My skin condition is mild or clear, and I don't have a diagnosis of Atopic Dermatitis.
Select...
I understand the study and agree to participate.
Select...
I am between 3 months and 11 years old.
PAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of children's nighttime scratching episodes
Number of children's nighttime scratching episodes
Scratch assessment by adult caregiver
Side effects data
From 2022 Phase 3 trial • 620 Patients • NCT040401926%
Application site pain
2%
Dermatitis atopic
2%
Upper respiratory tract infection
1%
Influenza
1%
Application site pruritus
1%
Application site infection
1%
Nasopharyngitis
1%
Application site erythema
1%
Dermatitis contact
1%
Eczema
1%
Food allergy
100%
80%
60%
40%
20%
0%
Study treatment Arm
OL: Crisaborole 2% BID
DB: Vehicle
DB: Crisaborole 2% QD
DB Flare: Vehicle
DB Flare: Crisaborole 2% QD
PAD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Crisaborole 2%Experimental Treatment3 Interventions
Adult caregivers of children participants will be asked to apply a thin even-layer of Crisaborole (2%) twice daily for 2 weeks.
Group II: Vehicle ArmActive Control3 Interventions
Adult caregivers of children participants will be asked to apply a thin even-layer of vehicle treatment twice daily for 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Crisaborole 2%
2019
Completed Phase 4
~660
Find a Location
Who is running the clinical trial?
PfizerIndustry Sponsor
4,583 Previous Clinical Trials
14,635,491 Total Patients Enrolled
Boston UniversityLead Sponsor
460 Previous Clinical Trials
9,954,765 Total Patients Enrolled
Kevin C Thomas, PhDPrincipal InvestigatorBU School of Medicine, Anatomy and Neurobiology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You work night shifts or have traveled across more than two time zones in the past 2 weeks or during the study.I am the main caregiver for a child in the study and am between 18 and 75 years old.You are allergic to materials like polyurethane resin, nickel, silicone, or adhesives.I agree not to apply crisaborole near my mouth or on my hands.I haven't taken steroids or immunosuppressants in the last 35 days.I do not have any serious infections.My skin condition is rated as mild or moderate by my doctor.I have not consumed more than the recommended weekly alcohol limit in the past 6 months.My skin condition affects more than 5% but less than 40% of my body, not including my scalp.I have been diagnosed with atopic dermatitis.You have had angioedema or anaphylaxis in the past.My skin condition is mild or clear, and I don't have a diagnosis of Atopic Dermatitis.I understand the study and agree to participate.I do not have any major health issues that would stop me from joining the study.I have been treated with crisaborole.My child's asthma is not well-controlled, based on their test score.I am currently pregnant.I agree not to use creams or lotions on my AD lesions unless they are on my face or hands.I cannot wear a device on at least one of my wrists.Crisaborole did not work for my condition.I have a surgery or medical procedure planned that may interfere with the study.I am a native English speaker or I am fluent in English.You can read and understand at an 8th grade level or higher.I am not part of the study staff, their family, or a BU/BMC employee involved in the study.I do not have any health issues that would stop me from participating in the study.I am between 3 months and 11 years old.I have used skin treatments for my condition within the last 14 days, except on my face and hands.My child has had an itchiness score of at least 2.You have a skin condition with a score of 3 or higher on a specific test before the study starts.I have a sleep disorder not related to Alzheimer's disease.
Research Study Groups:
This trial has the following groups:- Group 1: Crisaborole 2%
- Group 2: Vehicle Arm
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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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