Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
12–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female 12 to 17 years of age, inclusive
Clinical diagnosis of atopic dermatitis (according to the criteria of Hanifin and Rajka)
AD in treatable areas (excludes the scalp and venous access areas) involving
≥10% and ≤35% of the total body surface area(BSA)
Investigator's Static Global Assessment (ISGA) score of 2 or 3
Normal or not clinically significant screening laboratory results
Have adequate venous access to permit repeated PK sampling on Days 1 - 9 through uninfected skin that has not been treated with study drug; each untreated venous access area should provide a margin of at least 5 cm radius around the venipuncture site
Willing and able to comply with study instructions and commit to attending all visits
Females must use a highly effective method of birth control.
Parent/guardian has the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol-related procedures; subject has the ability to give assent
You may not be if
Significant confounding conditions as assessed by study doctor
Unstable or actively infected AD
Active or potentially recurrent dermatologic condition other than atopic dermatitis that may confound evaluation
History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within the last 5 years
Current pregnancy or lactation, or intent to become pregnant during the study
Known sensitivity to any of the components of the study drug
Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
