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

Healthy Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT03760042
• Study type: Interventional
• Source: Pfizer
• Status: Completed
• Phase: Phase 1
• Start date: November 14, 2018
• Completion date: April 15, 2019