Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369675
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2017-08-01
Brief Title:
Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design
Sponsor:
Moberg Pharma AB
Organization:
Moberg Pharma AB
Study Overview
Official Title:
A 21-Day Randomized Controlled Study to Evaluate the Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design
Status:
COMPLETED
Status Verified Date:
2024-04
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:
CIPT
Brief Summary:
A 21-Day Randomized Controlled Study to Evaluate the Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design To evaluate the irritation potential of MOB015B on normal skin Single center randomized controlled evaluator blinded within-subject comparison study
Detailed Description:
MOB015B is a newly developed topical solution for the treatment of nail fungus onychomycosis containing the active antifungal ingredient terbinafine A This study investigates the irritation potential of MOB015B under standardized conditions compared with a known irritant 02 SLS and an inert control normal saline Because MOB015B is formulated for topical use it is necessary to determine the potential of this product to cause irritation after repeated topical application to the skin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None