Evaluation of Skin Irritation Potential With PF-06700841 Cream Formulation Using Negative Control in Adult Japanese Healthy Participants

NCT03916250

Last updated date
Study Location
Medical Corporation Heishinkai OPHAC Hospital
Osaka-shi, Osaka, 532-0003, Japan
Contact
1-800-718-1021

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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
20-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female participants must be 20 to 55 years of age, inclusive, at the time of signing the informed consent document.

- Body mass index (BMI) of 17.5 to 25 kg/m2; and a total body weight >50 kg (110 lb).

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


- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or
allergic disease.


- Participants who have any visible skin condition at the application site which, in the
opinion of the investigative personnel, will interfere with the evaluation of the test
site reaction.


- Participants who have psoriasis and/or active AD/eczema/urticaria.


- Participants who have a history of AD.


- Participants 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.


- History of known or suspected intolerance to any of the ingredients of the
investigational products, adhesive tape/plaster, or the test patches.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation of Skin Irritation Potential With PF-06700841 Cream Formulation Using Negative Control in Adult Japanese Healthy Participants
Official Title  ICMJE A PHASE 1, SINGLE-CENTER, RANDOMIZED, VEHICLE AND WHITE PETROLATUM CONTROLLED, EVALUATOR BLINDED STUDY TO ASSESS THE SKIN IRRITATION POTENTIAL WITH A RANGE OF CONCENTRATIONS OF PF-06700841 CREAM IN ADULT JAPANESE HEALTHY PARTICIPANTS
Brief Summary This is a Phase 1, single center, randomized, vehicle and white petrolatum controlled, evaluator blinded study to assess the skin irritation potential with a range of concentrations of PF-06700841 cream including vehicle and empty patch with white petrolatum under occlusive conditions in adult Japanese healthy participants.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-06700841 cream
    PF-06700841 will be applied topically
    Other Name: PF-06700841 cream 0% is Vehicle
  • Drug: White petrolatum
    White petrolatum will be applied topically
Study Arms  ICMJE
  • Experimental: PF-06700841 cream 0%
    All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential
    Intervention: Drug: PF-06700841 cream
  • Experimental: PF-06700841 cream 0.1%
    All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential
    Intervention: Drug: PF-06700841 cream
  • Experimental: PF-06700841 cream 0.3%
    All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential
    Intervention: Drug: PF-06700841 cream
  • Experimental: PF-06700841 cream 1%
    All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential
    Intervention: Drug: PF-06700841 cream
  • Experimental: PF-06700841 cream 3%
    All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential
    Intervention: Drug: PF-06700841 cream
  • Experimental: White petrolatum
    All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential
    Intervention: Drug: White petrolatum
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: April 12, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 12, 2019
Actual Primary Completion Date April 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female participants must be 20 to 55 years of age, inclusive, at the time of signing the informed consent document.
  • Body mass index (BMI) of 17.5 to 25 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
  • Participants who have any visible skin condition at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction.
  • Participants who have psoriasis and/or active AD/eczema/urticaria.
  • Participants who have a history of AD.
  • Participants 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.
  • History of known or suspected intolerance to any of the ingredients of the investigational products, adhesive tape/plaster, or the test patches.
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 NCT03916250
Other Study ID Numbers  ICMJE B7931029
Has Data Monitoring Committee No
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: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/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP