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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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NCT03760042

Last updated on November 14, 2019
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FOR MORE INFORMATION
Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT03760042
Pfizer
Recruiting
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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Descriptive Information
Brief Title  ICMJE Study To Assess Local Tolerability of Crisaborole 2% Ointment and Vehicle Ointment In Healthy Participants Using Subject-reported Assessments and Objective Measurements
Official Title  ICMJE 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
Brief SummaryA double-blind within-subject study to estimate observed application site adverse events following topical applications of crisaborole and vehicle in healthy participants
Detailed DescriptionTo 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
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)
Masking Description:

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.

Primary Purpose: Other

Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Within-Subject Active vs Placebo Topical Applications
    Crisaborole 2% ointment (right side) and Placebo vehicle ointment (left side)
  • Drug: Within-Subject Active vs. Placebo Topical Applications
    Crisaborole 2% ointment (left side) and Placebo vehicle ointment (right side)
Study Arms  ICMJE
  • 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
    Intervention: Drug: Within-Subject Active vs Placebo Topical Applications
  • 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

    Intervention: Drug: Within-Subject Active vs. Placebo Topical Applications
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 28, 2018)		32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 15, 2019
Actual Primary Completion DateApril 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03760042
Other Study ID Numbers  ICMJE C3291042
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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