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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03916250
• Other study ID #: B7931029
• Status: Completed
• Phase: Phase 1
• Start date: March 23, 2019
• Est. completion date: May 12, 2019

Study information

• Verified date: May 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 12, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-06700841 cream
PF-06700841 will be applied topically
• White petrolatum
White petrolatum will be applied topically

Locations

Country	Name	City	State
Japan	Medical Corporation Heishinkai OPHAC Hospital	Osaka-shi	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of participants who have skin irritation grade equal to or greater than two plus (++) 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 (++++)	Up to Day 4
Secondary	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)	Skin irritation grade is defined as following: no reaction (-); slight erythema (+-); erythema (+); erythema + edema, papules (++); erythema + edema + papules + vesicles (small blisters) (+++) ; large blisters (++++)	Day 3 and Day 4
Secondary	The number of the maximum skin irritation score reported up to Day 4 by treatment	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)	Up to Day 4
Secondary	The percentage of the maximum skin irritation score reported up to Day 4 by treatment	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)	Up to Day 4
Secondary	The number of each skin irritation score reported by treatment on each assessment day	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)	Day 3 and Day 4
Secondary	The percentage of each skin irritation score reported by treatment on each assessment day	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)	Day 3 and Day 4
Secondary	Number of Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)		Baseline up to Day 35
Secondary	Number of Participants Discontinuation Due to AEs		Baseline up to Day 35

External Links

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