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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|ClinicalTrials.gov Identifier: NCT03760042|
Recruitment Status : Completed
First Posted : November 30, 2018
Last Update Posted : June 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Within-Subject Active vs Placebo Topical Applications Drug: Within-Subject Active vs. Placebo Topical Applications||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
Crisaborole 2% ointment and matching crisaborole vehicle will be supplied by Pfizer to the CRU as packaged 60 gram tubes and labeled according to local regulatory requirements in an unblinded fashion.
Crisaborole and vehicle ointment doses for the 14 pre-specified application sites bilaterally will be prepared by the unblinded PCRU pharmacist and provided to the blinded investigational site staff in individual dose containers. Subjects will be blinded to side of body treated with crisaborole and side of body treated with vehicle.
|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|
|Actual Study Start Date :||November 14, 2018|
|Actual Primary Completion Date :||April 15, 2019|
|Actual Study Completion Date :||April 15, 2019|
Group A (Crisaborole RIGHT SIDE / Vehicle LEFT SIDE)
Crisaborole ointment 2% applied to sensitive skin locations on right side of body. Crisaborole placebo vehicle ointment applied to sensitive skin locations on left side of body
Drug: Within-Subject Active vs Placebo Topical Applications
Crisaborole 2% ointment (right side) and Placebo vehicle ointment (left side)
Group B (Crisaborole LEFT SIDE / Vehicle RIGHT SIDE)
Crisaborole placebo vehicle ointment applied to 7 sensitive skin sites on right side of body.
Crisaborole ointment 2% applied to 7 sensitive skin locations on left side of body
Drug: Within-Subject Active vs. Placebo Topical Applications
Crisaborole 2% ointment (left side) and Placebo vehicle ointment (right side)
- Frequency and Severity of Application site treatment emergent adverse events (TEAEs) in crisaborole treated versus vehicle-treated prespecified sensitive skin sites [ Time Frame: 3 days ]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.
- Neurometric Measurement (Current Perception Threshold in mAmps) on Right-side and Left-side of Body (face, upper and lower extremities bilaterally) [ Time Frame: 1 day ]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) .
- 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 [ Time Frame: 1 day ]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").
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760042
|United States, Connecticut|
|New Haven Clinical Research Unit|
|New Haven, Connecticut, United States, 06511|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|