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

• Status: Completed
• Trial end date: 2019-04-15
• Target enrollment: 0
• Participant gender: All

Summary

A double-blind within-subject study to estimate observed application site adverse events following topical applications of crisaborole and vehicle in healthy participants

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Male and female adult participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.

Exclusion Criteria:

• 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.