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

NCT ID: NCT01494714

Last Updated: 2012-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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This is a single center, interpreter-blinded (the person interpreting the results does not know the name of the assigned drug), randomized (drug is assigned by chance like flipping a coin), vehicle-controlled, closed-patch test study. Thirty (30) Japanese participants will be enrolled in the study. Each treatment (JNJ 10229570-AAA at 1.2%, 2.4%, 3.6%, vehicle in a cream formulation, and petroleum jelly) will be randomly applied in vertical position on the back of each participant, with a corresponding strength applied at the same vertical position (left vs. right). The study drugs applied on the left side will be washed off at 48 hours after application. The dermatological evaluation and photo shoots will be done at 1 (T49) and 24 (T72) hours after washing off the drugs. All participants who completed the dermatological evaluation will be included in the evaluation of skin irritation and skin photo irritation. The study drugs applied on the right side will be washed off at 24 hours after application. The dermatological evaluation and photo shoots will be done at 1 hour after washing off. Ultraviolet A (UVA) will be irradiated to the application site. One hour after irradiation start (T26), the dermatological evaluation and photo shoots will be done. Afterwards the application site will be covered for the protection against UV. Twenty-four hours after washing off (T48), the cover will be taken off, and then the dermatological evaluation and photo shoots will be done at 1 (T49) and 24 (T72) hours. Additionally, the safety profile of JNJ 10229570-AAA will be assessed during the study. The study has a total duration of maximum 32 days.

Conditions

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Healthy Volunteers

Keywords

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Healthy volunteers JNJ 10229570-AAA Skin irritation Skin photo irritation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Closed-patch test

Group Type EXPERIMENTAL

JNJ 10229570-AAA 1.2% cream

Intervention Type 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.

JNJ 10229570-AAA 2.4% cream

Intervention Type 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.

JNJ 10229570-AAA 3.6% cream

Intervention Type 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.

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

Intervention Type 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.

Petroleum jelly

Intervention Type 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.

Interventions

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JNJ 10229570-AAA 1.2% cream

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.

Intervention Type DRUG

JNJ 10229570-AAA 2.4% cream

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.

Intervention Type DRUG

JNJ 10229570-AAA 3.6% cream

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.

Intervention Type DRUG

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

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.

Intervention Type DRUG

Petroleum jelly

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

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Fukukoka, , Japan

Site Status

Hakata, , Japan

Site Status

Countries

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Japan

Other Identifiers

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10229570-JPN-01

Identifier Type: OTHER

Identifier Source: secondary_id

CR018670

Identifier Type: -

Identifier Source: org_study_id