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

Last updated on November 7, 2019

FOR MORE INFORMATION
Study Location
Medical Corporation Heishinkai OPHAC Hospital
Osaka-shi, Osaka, 532-0003 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy, Atopic Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

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.

NCT03260595
Pfizer
Not yet recruiting
A Study of Crisaborole Ointment 2% in Adult Japanese Healthy Subjects and Adult Japanese Subjects With Mild To Moderate Atopic Dermatit

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Descriptive Information
Brief Title  ICMJE A Study of Crisaborole Ointment 2% in Adult Japanese Healthy Subjects and Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis
Official Title  ICMJE 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
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy
  • Atopic Dermatitis
Intervention  ICMJE
  • Drug: Crisaborole ointment 2%
    Crisaborole ointment 2%
  • Drug: Vehicle
    Vehicle
Study Arms  ICMJE
  • Experimental: Crisaborole ointment 2%
    Intervention: Drug: Crisaborole ointment 2%
  • Placebo Comparator: Vehicle
    Intervention: Drug: Vehicle
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: August 23, 2017)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 27, 2017
Actual Primary Completion DateNovember 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03260595
Other Study ID Numbers  ICMJE C3291029
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:No
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
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: http://www.pfizer.com/research/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 DateOctober 2018

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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