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Study To Assess Local Tolerability of Crisaborole 2% Ointment and Vehicle Ointment In Healthy Participants Using Subject-reported Assessments and Objective Measurements

Last updated on June 26, 2019

FOR MORE INFORMATION
Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male and female adult participants who are overtly healthy as determined by medical
evaluation including medical history, physical examination, and laboratory tests.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Prior self-reported history of any chronic relapsing inflammatory skin disease,
including atopic dermatitis.

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing). Any clinically significant medical
conditions or history of such conditions that, in the opinion of the Investigator may
place the participant at an unacceptable risk as a participant in this trial.

- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C;
positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core
antibody (HBcAb), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.

- History of serious adverse reactions or hypersensitivity to any topical drug (eg,
crisaborole); or known allergy to any of the test product(s) or any components (eg,
lactic acid) in the test product(s) or history of hypersensitivity; or allergic
reactions to any of the study preparations

- Abnormal physical findings of clinical significance or dermatological condition (eg
extensive tattooing or excessive scarring at 14 sensitive skin application sites) at
the Screening examination or Baseline which would interfere with the objectives of the
study in the opinion of the Principal Investigator.

- Daily use of medications that could interfere with the objectives of the study (such
as lidocaine, gabapentin, pregabalin, narcotics, antihistamines, oral or parenteral
corticosteroids, non-narcotic analgesics and anti-inflammatories) within 1 week of
screening and during the study.

- Not willing to refrain from shaving, the use of depilatories or other hair-removal
activities, antiperspirants, lotions, skin creams, fragrances or perfumes, or body
oils (eg, baby oil; coconut oil), use of hair products, hair gels, and hair oil in the
treatment areas for 48 hours prior to admission to the PCRU and for the duration of
the stay in the PCRU.

NCT03760042
Pfizer
Completed
Study To Assess Local Tolerability of Crisaborole 2% Ointment and Vehicle Ointment In Healthy Participants Using Subject-reported Assessments and Objective Measurements

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Pfizer Clinical Trials Contact Center

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[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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