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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

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

Drug: JNJ 10229570-AAA 1.2% cream

Drug: JNJ 10229570-AAA 2.4% cream

Drug: Petroleum jelly

Drug: JNJ 10229570-AAA 3.6% cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT01494714

10229570-JPN-01 (Other Identifier)

CR018670

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 patients

Sex

Male

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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