Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-01-04 @ 5:07 PM
Study NCT ID:
NCT02192203
Status:
COMPLETED
Last Update Posted:
2017-06-28
First Post:
2014-05-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety Study to Investigate the Skin Sensitization Potential of MFC51123
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Safety Study to Investigate the Skin Sensitization Potential of MFC51123
Status:
COMPLETED
Status Verified Date:
2017-06
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:
This research study is being carried out to determine the possibility that a new medication causes allergic reactions. This new medication contains two active ingredients (diclofenac and menthol) together in a gel and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, and sprains and strains. Approximately 240 participants will have the medication (gel) applied to the skin on a small area of the upper back for approximately 48-hour or 72-hour periods over the course of six weeks. Participation in this research study is voluntary, requiring participants to visit the study clinic on 17 occasions for about 45 minutes each visit. During the visits, doctors or trained staff members will examine the amount of redness, swelling, and other signs of irritation (if any) of the skin where the medication (gel) was applied.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RH02169 | OTHER | GSK | View |