A double-blind within-subject study to estimate observed application site adverse events following topical applications of crisaborole and vehicle in healthy participants
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
32
Crisaborole 2% ointment (right side) and Placebo vehicle ointment (left side)
Crisaborole 2% ointment (left side) and Placebo vehicle ointment (right side)
New Haven Clinical Research Unit
New Haven, Connecticut, United States
Frequency and Severity of Application site treatment emergent adverse events (TEAEs) in crisaborole treated versus vehicle-treated prespecified sensitive skin sites
Comparison of investigator-reported (Application Site Skin Examination \[0 to 3 points\]) and participant-reported (Local Tolerability Assessment Scale scores \[0 to 3 points\]) application site TEAEs in crisaborole treated versus vehicle-treated at all 7 prespecified sensitive skin sites.
Time frame: 3 days
Neurometric Measurement (Current Perception Threshold in mAmps) on Right-side and Left-side of Body (face, upper and lower extremities bilaterally)
Comparison of Current Perception Threshold (CPT) measurements in participants bilaterally (face, upper extremities, lower extremities) to summarize CPT (absolute value in milliAmperes and right-left differential in milliAmperes) prior to study drug dosing (CPT assessments performed at 5 Hz, 250 Hz, and 2000 Hz) .
Time frame: 1 day
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
Lactic Acid Stinging Test assessment showing Local Tolerability Assessment Scale score of 2 or 3 on lactic acid treated side AND a difference of at least 1 between lactic acid treated side and placebo treated side (ie, "stingers") versus Local Tolerability Assessment Scale score \[ranging from 0 to 3 points\] of 1 or less on lactic acid treated side (ie, "non-stingers").
Time frame: 1 day
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