Ignite Creation Date:
2024-05-06 @ 1:20 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01782729
Status:
COMPLETED
Last Update Posted:
2013-04-15
First Post:
2013-01-31
Brief Title:
An Efficacy and Safety Study of Tacrolimus Ointment in Pediatric Participants With Atopic Dermatitis
Sponsor:
Janssen-Cilag LtdThailand
Organization:
Janssen-Cilag LtdThailand
Study Overview
Official Title:
The Efficacy and Safety of Tacrolimus Ointment in Pediatric Patients With Moderate to Severe Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2013-04
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 efficacy of tacrolimus ointment in treating the signs and symptoms of moderate medium level of seriousness to severe very serious life threatening atopic dermatitis an intensely pruritic itching chronic lasting a long time inflammatory pain and swelling immunologically based skin disease with a genetic predisposition latent susceptibility to disease at the genetic level in pediatric participants
Detailed Description:
This is an open-label all people know the identity of the intervention study in pediatric 2-12 years participants with moderate to severe atopic dermatitis Participants will be treated with 003 percent concentration of tacrolimus ointment which will be applied twice daily for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared whichever is first The study visits will consist of 6 visits pre-study optional Baseline Weeks 1 2 3 and 4 The ointment should be applied at least 2 hours before or at least 30 minutes after bathing showering shaving use of sauna or heavy exercise ie causes sweating On study visit days the ointment should be applied at least 2 hours before the visit Efficacy evaluation will be done at all subsequent study visits in participants receiving study drug for at least 3 consecutive days minimum of 5 applications while the participants who will receive at least 1 application of the study drug will be evaluated for safety Primary efficacy evaluation will be based on the Physicians Global Evaluation of Clinical Response PhGECR Participants safety will be monitored throughout the study
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 |
|---|---|---|---|
| R098924ADM4007 | None | None | None |