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

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ClinicalTrials.gov Identifier: NCT03916250
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-06700841 cream Drug: White petrolatum Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 23, 2019
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : May 12, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Petrolatum

Arm Intervention/treatment
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
Drug: PF-06700841 cream
PF-06700841 will be applied topically
Other Name: PF-06700841 cream 0% is Vehicle

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
Drug: PF-06700841 cream
PF-06700841 will be applied topically
Other Name: PF-06700841 cream 0% is Vehicle

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
Drug: PF-06700841 cream
PF-06700841 will be applied topically
Other Name: PF-06700841 cream 0% is Vehicle

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
Drug: PF-06700841 cream
PF-06700841 will be applied topically
Other Name: PF-06700841 cream 0% is Vehicle

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
Drug: PF-06700841 cream
PF-06700841 will be applied topically
Other Name: PF-06700841 cream 0% is Vehicle

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
Drug: White petrolatum
White petrolatum will be applied topically




Primary Outcome Measures :
  1. The proportion of participants who have skin irritation grade equal to or greater than two plus (++) up to Day 4 [ Time Frame: Up to Day 4 ]
    Skin irritation grade is defined as following: no reaction (-); slight erythema (+-); erythema (+); erythema + edema, papules (++); erythema + edema + papules + vesicles (small blisters) (+++) ; large blisters (++++)


Secondary Outcome Measures :
  1. The proportion of participants who have skin irritation grade equal to or greater than two plus (++) on each assessment day (Day 3 and Day 4) [ Time Frame: Day 3 and Day 4 ]
    Skin irritation grade is defined as following: no reaction (-); slight erythema (+-); erythema (+); erythema + edema, papules (++); erythema + edema + papules + vesicles (small blisters) (+++) ; large blisters (++++)

  2. The number of the maximum skin irritation score reported up to Day 4 by treatment [ Time Frame: Up to Day 4 ]
    Skin irritation score is defined as following: no reaction (0); slight erythema (0.5); erythema (1); erythema + edema, papules (2); erythema + edema + papules + vesicles (small blisters) (3) ; large blisters (4)

  3. The percentage of the maximum skin irritation score reported up to Day 4 by treatment [ Time Frame: Up to Day 4 ]
    Skin irritation score is defined as following: no reaction (0); slight erythema (0.5); erythema (1); erythema + edema, papules (2); erythema + edema + papules + vesicles (small blisters) (3) ; large blisters (4)

  4. The number of each skin irritation score reported by treatment on each assessment day [ Time Frame: Day 3 and Day 4 ]
    Skin irritation score is defined as following: no reaction (0); slight erythema (0.5); erythema (1); erythema + edema, papules (2); erythema + edema + papules + vesicles (small blisters) (3) ; large blisters (4)

  5. The percentage of each skin irritation score reported by treatment on each assessment day [ Time Frame: Day 3 and Day 4 ]
    Skin irritation score is defined as following: no reaction (0); slight erythema (0.5); erythema (1); erythema + edema, papules (2); erythema + edema + papules + vesicles (small blisters) (3) ; large blisters (4)

  6. Number of Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 35 ]
  7. Number of Participants Discontinuation Due to AEs [ Time Frame: Baseline up to Day 35 ]


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

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.

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 ClinicalTrials.gov identifier (NCT number): NCT03916250


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

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03916250     History of Changes
Other Study ID Numbers: B7931029
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
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/data_requests.

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

Additional relevant MeSH terms:
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Petrolatum
Emollients
Dermatologic Agents