A Study of JNJ 10229570-AAA to Evaluate Safety and Tolerability in Japanese Participants With Acne Vulgaris

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tolerability of JNJ 10229570-AAA after a single topical application of JNJ 10229570-AAA 1.2% and 3.6% cream in Japanese participants with acne.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.

Criteria

Inclusion Criteria:

• Have Acne vulgaris, presenting at least inflammatory lesion on the face

• Body mass index between 18.0 and 30.0 kg/m2 (inclusive), and body weight not less than 50 kg (man) or 45 kg (woman)

• 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

• Adequate contraception method for both men and women. If a woman, must have a negative pregnancy test

• Signed an informed consent document

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 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