Clinical trial NCT03760042: Study To Assess Local Tolerability of Crisaborole 2% Ointment and Vehicle Ointment In Healthy Participants Using Subject-reported Assessments and Objective Measurements
Official title: PHASE 1 RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, INTRA-SUBJECT STUDY TO ASSESS LOCAL TOLERABILITY OF CRISABOROLE 2% OINTMENT AND VEHICLE IN HEALTHY PARTICIPANTS USING SUBJECT-REPORTED ASSESSMENTS AND OBJECTIVE MEASUREMENTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-11-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Using surrogate markers of skin sensitivity (current perception threshold and lactic acid stinging test responses) to stratify risk for developing application site treatment emergent adverse events (AS-TEAEs), within-subject comparisons will quantify AS-TEAE frequency and severity in healthy participants following double-blind applications of crisaborole ointment and vehicle ointment at 7 sensitive skin anatomic locations.
Primary purpose: OTHER

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

Detailed description: To further understand the potential for crisaborole to evoke skin irritancy, a within-subject comparison study, C3291042 will assess the local tolerability of crisaborole 5 mg/cm² in healthy participants, who have had baseline assessments of surrogate markers of skin sensitivity-i.e. current perception threshold (CPT) measurements and standardized lactic acid stinging test (LAST) assessments. To further the clinical understanding of application site pain, responses to crisaborole ointment compared to crisaborole vehicle ointment will be assessed in comparisons based upon CPT (low versus high; symmetry versus asymmetry) and response to LAST ("stingers" versus "non-stingers"). This exploration of skin sensitivity characterizations in healthy participants exposed to crisaborole 5 mg/cm² will assess application site burning, stinging, and pain as well as other application site characteristics selected from a MedDRA-based list of terms by the participants. More advanced understanding of baseline application site sensation in healthy participants prior to higher local application rate of topical crisaborole may provide strategies for topical dermatologic product development programs striving to prevent or minimize application site sensory adverse events.

Eligibility 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.

Primary outcomes:
measure: Frequency and Severity of Application site treatment emergent adverse events (TEAEs) in crisaborole treated versus vehicle-treated prespecified sensitive skin sites
timeFrame: 3 days
Secondary outcomes:
measure: Neurometric Measurement (Current Perception Threshold in mAmps) on Right-side and Left-side of Body (face, upper and lower extremities bilaterally)
timeFrame: 1 day
measure: Quantify Participant's response to Lactic Acid Stinging Test (LAST) utilizing the Local Tolerability Assessment Scale (ranging from 0 to 3 points) to categorize as Stinger or Non-stinger
timeFrame: 1 day
Other outcomes:
Locations:
city: New Haven
country: United States
facility: New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: