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