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Crisaborole for Eczema (PAD Trial)
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.
PAD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPAD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 620 Patients • NCT04040192PAD Trial Design
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Who is running the clinical trial?
Media Library
- 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.
- Group 1: Crisaborole 2%
- Group 2: Vehicle Arm
- 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.
- 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.
Frequently Asked Questions
Are there any enrolment opportunities for this research experiment?
"Affirmative. As documented on clinicaltrials.gov, this research project is presently in search of participants since it was posted on July 26th and most recently revised on the 29th. 540 candidates need to be enrolled between one location for successful completion of the trial."
To what extent is enrollment available for this trial?
"Affirmative, clinicaltrials.gov serves as evidence that this experiment is currently recruiting participants. Data suggests it was posted on July 26th 2022 and recently updated on the 29th of the same month. 540 individuals need to be enrolled across 1 site for successful completion of this study."
Does the eligibility criteria for this research include individuals who are octogenarians?
"To be eligible for this medical experiment, applicants must fall between the ages of 3 Months and 75. There are 101 trials available to those under 18 and 165 studies oriented towards seniors over 65 years old."
Are there any adverse consequences to using Crisaborole 2% in a therapeutic setting?
"Due to the fact that Crisaborole 2% is a Phase 4 drug, our team at Power gave this medication an estimated safety score of 3."
What types of people are ideal candidates for this medical trial?
"This clinical trial seeks to enrol 540 patients ranging from 3 months to 75 years of age who suffer from dermatitis. In order for applicants to qualify, they must meet all the following conditions: Male or female aged between ≥3 months and <5 years at Day -7., ISGA score of Mild (2) or Moderate (3) as per baseline visit., EASI total score of ≥3 on Day -7., Refrainment from applying diaper rash creams et cetera over troubled areas, Written informed consent procured by participant/parent(s)/guardian(s)., Fluency in English is a requirement"
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