Ignite Creation Date:
2024-05-06 @ 12:07 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01494714
Status:
COMPLETED
Last Update Posted:
2012-10-31
First Post:
2011-12-13
Brief Title:
A Study to Evaluate Skin Irritation and Photo Irritation of JNJ 10229570-AAA on Intact Skin of Japanese Healthy Male Participants
Sponsor:
Janssen Pharmaceutical KK
Organization:
Janssen Pharmaceutical KK
Study Overview
Official Title:
A Study to Evaluate Skin Irritation and Photo Irritation of JNJ 10229570-AAA on Intact Skin of Japanese Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2012-10
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 skin irritation and photo irritation of JNJ 10229570-AAA on intact skin of Japanese healthy male participants
Detailed 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 12 24 36 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
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-01 | OTHER | Janssen Pharmaceutical KK Japan | None |