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Completed

NCT Number: NCT03916250

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

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.

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical Corporation Heishinkai OPHAC Hospital

Osaka, 532-0003, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-06700841 cream

Drug

PF-06700841 will be applied topically

Other names: PF-06700841 cream 0% is Vehicle

White petrolatum

Drug

White petrolatum will be applied topically

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2019
Registry last updated
May 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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