A Study to Evaluate Skin Irritation and Photo Irritation of JNJ 10229570-AAA on Intact Skin of Japanese Healthy Male Participants

NCT01494714 | Completed Phase 1

• 2 other identifiers: CR01867010229570-JPN-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate skin irritation and photo irritation of JNJ 10229570-AAA on intact skin of Japanese healthy male participants.

Conditions

Healthy Volunteers

Keywords

Healthy volunteers; JNJ 10229570-AAA; Skin irritation; Skin photo irritation

Outcome Measures

Primary Outcomes (2)

• Skin irritation according to the Japanese evaluation criteria (scores on a scale)

  The Japanese skin irritation evaluation criteria is a 6-point scale specifying the irritation level of the skin, from 0 (no response) to 4 (blister)

  72 hours

• Skin photo irritation according to the Japanese evaluation criteria (scores on a scale)

  The Japanese skin photo irritation evaluation criteria is a 6-point scale specifying the level of skin photo irritation from 0 (lack of reaction or reaction comparable to non-irradiated site) to 4 (reaction four ranks more pronouced using domestic criteria compared with non-irradiated site)

  72 hours

Secondary Outcomes (3)

• Skin irritation according to the International Contact Dermatitis Research Group (ICDRG) criteria (measurements on a scale)

  72 hours

• Skin photo irritation according to the International Contact Dermatitis Research Group (ICDRG) criteria (measurements on a scale)

  72 hours

• Number of participants with adverse events as a measure of safety and tolerability

  32 days

Study Arms (1)

Closed-patch test

EXPERIMENTAL

Drug: JNJ 10229570-AAA 1.2% cream; Drug: JNJ 10229570-AAA 2.4% cream; Drug: JNJ 10229570-AAA 3.6% cream; Drug: Color-matched vehicle in a cream formulation containing 0 mg of JNJ 10229570-AAA; Drug: Petroleum jelly

Interventions

JNJ 10229570-AAA 1.2% cream DRUG

A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.

Closed-patch test

JNJ 10229570-AAA 2.4% cream DRUG

A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.

Closed-patch test

JNJ 10229570-AAA 3.6% cream DRUG

A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.

Closed-patch test

Color-matched vehicle in a cream formulation containing 0 mg of JNJ 10229570-AAA DRUG

A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.

Closed-patch test

Petroleum jelly DRUG

A patch containing the petroleum jelly will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.

Closed-patch test

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed an informed consent document
• Body mass index between 18.0 and 30.0 kg/m2 (inclusive), and body weight not less than 50 kg
• Blood pressure between 90 and 140 mmHg systolic (inclusive), and no higher than 90 mmHg diastolic
• Electrocardiogram (ECG) consistent with normal cardiac conduction and function
• Non-smoker
• Agree to use an adequate contraception method

You may not qualify if:

• History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
• Clinically significant abnormal values for hematology, biochemistry or urinalysis
• Clinically significant abnormal physical examination, vital signs or ECG
• Use of any prescription or nonprescription medication (including vitamins and herbal supplements) within 14 days before the study treatment
• History of drug or alcohol abuse within the past 5 years
• Drug allergy or drug hypersensitivity
• Blood donation, depending on the volume of blood collection
• Positive test for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis
• Dermatological disease at application site
• Photosensitivity
• Exposure to excessive or chronic ultraviolet (UV) radiation (i.e., sunbathing, tanning salon use, phototherapy) within 4 weeks prior to study treatment or planned during the study period

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (2)

Unknown Facility

Fukukoka, Japan

Location

Unknown Facility

Hakata, Japan

Location

MeSH Terms

Interventions

Petrolatum

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 19, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 31, 2012

Record last verified: 2012-10

Locations

JP (2)