Clinical trial NCT03916250: Evaluation of Skin Irritation Potential With PF-06700841 Cream Formulation Using Negative Control in Adult Japanese Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The proportion of participants who have skin irritation grade equal to or greater than two plus (++) up to Day 4
timeFrame: Up to Day 4
Secondary outcomes:
measure: 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)
timeFrame: Day 3 and Day 4
measure: The number of the maximum skin irritation score reported up to Day 4 by treatment
timeFrame: Up to Day 4
measure: The percentage of the maximum skin irritation score reported up to Day 4 by treatment
timeFrame: Up to Day 4
measure: The number of each skin irritation score reported by treatment on each assessment day
timeFrame: Day 3 and Day 4
measure: The percentage of each skin irritation score reported by treatment on each assessment day
timeFrame: Day 3 and Day 4
measure: Number of Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 35
measure: Number of Participants Discontinuation Due to AEs
timeFrame: Baseline up to Day 35
Other outcomes:
Locations:
city: Osaka-shi
country: Japan
facility: Medical Corporation Heishinkai OPHAC Hospital
state: Osaka
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: