Status:
COMPLETED
A Study of JNJ 10229570-AAA to Evaluate Safety and Tolerability in Japanese Participants With Acne Vulgaris
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
20-35 years
Phase:
PHASE1
Brief 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.
Detailed Description
This is a randomized (drug assigned by chance like flipping a coin), double blinded (neither physician nor patient knows the name of the assigned drug), single dose ascending study of JNJ 10229570-AAA...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01492647
Start Date
August 1 2011
End Date
October 1 2011
Last Update
February 20 2013
Active Locations (2)
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1
Fukukoka, Japan
2
Hakata, Japan