Ignite Creation Date:
2024-05-06 @ 12:08 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01492647
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
2011-12-13
Brief Title:
A Study of JNJ 10229570-AAA to Evaluate Safety and Tolerability in Japanese Participants With Acne Vulgaris
Sponsor:
Janssen Pharmaceutical KK
Organization:
Janssen Pharmaceutical KK
Study Overview
Official Title:
A Randomized Double Blinded Single Topical Dose Study of JNJ 10229570-AAA to Evaluate Safety and Tolerability in Japanese Subjects With Acne Vulgaris
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 12 and 36 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 in Japanese participants with acne The study will evaluate the safety and pharmacokinetics PK how the drug is absorbed in the body how it is distributed within the body and removed from the body over time of M1 active metabolite in a total of eighteen 18 participants enrolled in the study nine 9 in each group Each participant will receive JNJ 10229570-AAA at 12 36 or vehicle in a cream formulation as a 25 mL application to the face neck shoulders chest and upper back areas The investigational product will be washed off after the blood sampling at 24 hours after application Safety and tolerability will be evaluated throughout the study and a topical dermatological assessment will be done by the dermatologists The total duration of the study will be maximum 35 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10229570-JPN-02 | OTHER | Janssen Pharmaceutical KK Japan | None |