A Study of Crisaborole Ointment 2% in Adult Japanese Healthy Subjects and Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03260595
Recruitment Status : Completed
First Posted : August 24, 2017
Last Update Posted : February 12, 2018
Information provided by (Responsible Party):

Brief Summary:
This is a Phase 1 parallel-cohort study of crisaborole ointment 2% to evaluate the skin irritation potential in adult Japanese healthy subjects in Cohort 1, and to evaluate the safety, tolerability and PK in adult Japanese subjects with mild to moderate AD in Cohort 2.

Condition or disease Intervention/treatment Phase
Healthy Atopic Dermatitis Drug: Crisaborole ointment 2% Drug: Vehicle Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Phase 1, Single-center, Randomized, Vehicle-controlled, Parallel-cohort Study Of Crisaborole Ointment 2% To Evaluate The Skin Irritation Potential In Adult Japanese Healthy Subjects, And To Evaluate The Safety, Tolerability And Pharmacokinetics In Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis
Actual Study Start Date : September 13, 2017
Actual Primary Completion Date : November 27, 2017
Actual Study Completion Date : November 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Crisaborole

Arm Intervention/treatment
Experimental: Crisaborole ointment 2% Drug: Crisaborole ointment 2%
Crisaborole ointment 2%

Placebo Comparator: Vehicle Drug: Vehicle

Primary Outcome Measures :
  1. Skin irritation index for Cohort 1 [ Time Frame: Day 4 ]

Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: Day 1 and 8 ]
  2. Time to reach maximum observed plasma concentration (Tmax) [ Time Frame: Day 1 and 8 ]
  3. Area under the plasma concentration-time curve from zero time until (AUClast) [ Time Frame: Day 1 and 8 ]
  4. Area under the plasma concentration-time curve from time zero to the 24 hours (AUC24) [ Time Frame: Day 1 and 8 ]
  5. Area under the plasma concentration-time curve from time zero to time tau (AUCt) [ Time Frame: Day 1 and 8 ]
  6. Accumulation ratio for Cmax [ Time Frame: Day 8 ]
  7. Accumulation ratio for AUCt [ Time Frame: Day 8 ]

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Cohort 1

  1. Healthy male Japanese subjects who, at the time of screening, are between the ages of 20 and 55 years, inclusive.
  2. Healthy skin on which reddening can be easily recognized in the area of the test fields.

Cohort 2

  1. Male or female Japanese subjects aged 20 years to 55 years (inclusive) at the time of screening, and in generally good health except for AD.
  2. Diagnosis of AD based on the criteria of Hanifin and Rajka (1980).
  3. Has at least 25% Treatable %BSA on Day 1 (excluding the scalp and designated venous access areas).
  4. Has an Investigator's static global assessment (ISGA) score of Mild (2) or Moderate (3) on Day 1.

Exclusion Criteria:

Cohort 1

  1. Subjects who have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction.
  2. Subjects who have psoriasis and/or active AD/eczema.
  3. Subjects who have a history of AD.
  4. Subjects who have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site.
  5. Known sensitivity to any of the components of the investigational products.
  6. History of the rash to the adhesive plaster, contact dermatitis to metal, or cosmetic and household articles.

Cohort 2

  1. Has any clinically significant medical disorder, condition, disease (including active or potentially recurrent dermatological conditions other than AD), significant physical examination or laboratory findings that may interfere with study objectives, in the Investigator's opinion.
  2. Has unstable AD or a consistent requirement for strong to strongest potency topical corticosteroids to manage AD signs and symptoms.
  3. Has a significant active systemic or localized infection, including known actively infected AD.
  4. Has a history or evidence of clinically significant or severe allergies (eg, seasonal, pet dander, environmental, food) requiring acute or chronic treatment.
  5. Has recent or anticipated concomitant use of topical or systemic therapies that might alter the course of AD.
  6. Has a history of recent (within 4 weeks of Day 1) sunbathing, tanning bed use, or ultraviolet (UV) light B therapy (UVB) or psoralen plus UVA [PUVA]).
  7. Has a known sensitivity to any of the components of crisaborole ointment 2%.
  8. Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03260595

Medical Corporation Heishinkai OPHAC Hospital
Osaka-shi, Osaka, Japan, 532-0003
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT03260595     History of Changes
Other Study ID Numbers: C3291029
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases