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

NCT03760042 | Completed Phase 1 FDA Drug

• 1 other identifier: C3291042
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  3 days

Secondary Outcomes (2)

• Neurometric Measurement (Current Perception Threshold in mAmps) on Right-side and Left-side of Body (face, upper and lower extremities bilaterally)

  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

  1 day

Study Arms (2)

Group A (Crisaborole RIGHT SIDE / Vehicle LEFT SIDE)

OTHER

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

Group B (Crisaborole LEFT SIDE / Vehicle RIGHT SIDE)

OTHER

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

Interventions

Within-Subject Active vs. Placebo Topical Applications DRUG

Crisaborole 2% ointment (left side) and Placebo vehicle ointment (right side)

Group B (Crisaborole LEFT SIDE / Vehicle RIGHT SIDE)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 30, 2018
• Study Start: November 14, 2018
• Primary Completion: April 15, 2019
• Study Completion: April 15, 2019
• Last Updated: June 24, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)