NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
Learn more about a Pfizer clinical trial for children who are 6 to 11 years of age.
Atopic dermatitis (AD), or eczema, is common in children. It causes patches of itchy, dry, and inflamed skin that can make it difficult to sleep or focus in school. Children with AD may also struggle with feelings of embarrassment and low self-esteem.
While there are treatments available, they may be ineffective, inconvenient, or cause unwanted side effects. That is why we are researching another potential option.
This clinical trial will help us learn if taking an oral study medicine in combination with approved topical therapies can help to improve atopic dermatitis in children who are 6 to 11 years old.
Joining a clinical trial is an important and personal decision. Thank you for considering participation.
This clinical trial is enrolling children who:
Condition
Atopic dermatitis (eczema)
Age
6-11 years
Medical history
Inadequate response to topical medications for AD/eczema in the last 6 months
Each clinical trial has its own guidelines for who can participate, called eligibility criteria. However, only the clinical trial team can determine if your child qualifies to enroll.
All participants will have a 2 in 3 chance of receiving the active study medicine. This means that for every 3 participants, 2 will receive the active study medicine, and 1 will receive a placebo. The placebo looks just like the study medicine but does not contain any active ingredients.
You will not know what your child has been assigned to receive. Your child will take the study medicine or placebo by mouth once daily for 16 weeks per protocol. During this time, you will also need to help your child apply topical therapies to affected areas at least once daily.
After 4 months, your child will be able to receive the study medicine in an open-label extension clinical trial (no chance of placebo).
Length of study treatment
16 weeks per protocol
Number of study visits
7 visits and 3 phone calls
Long-term follow up
28 days
The study medicine being evaluated in this clinical trial is an oral JAK inhibitor developed by Pfizer called abrocitinib (CIBINQO™). JAK inhibitors may work by blocking the overactive immune response that causes AD.
Abrocitinib is approved for use in adults and pediatric patients 12 years of age and older.
No one’s skin is exactly the same. Many factors, including genetics, race, ethnicity, and gender, can impact how people respond to medicine. That is why it is so important that clinical trials include people of all backgrounds.
The greater the diversity among clinical trial participants, the more we can learn about potential medicines, including how they work for different people.
There is no cost to participate in this clinical trial. You will also be compensated for completing clinical trial activities.
Participating in a clinical trial is your choice. You can choose to have your child leave the clinical trial at any time, for any reason, and your child’s regular medical care will not be affected.
Your child will have a 2 in 3 chance of receiving the study medicine in this clinical trial. After 4 months, your child will be able to join an open-label long-term extension clinical trial in which all participants will receive the study medicine (no chance of placebo).
