Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369727
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2017-08-01
Brief Title:
Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design
Sponsor:
Moberg Pharma AB
Organization:
Moberg Pharma AB
Study Overview
Official Title:
A Randomized Controlled Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult 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:
RIPT
Brief Summary:
A Randomized Controlled Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design To evaluate the sensitization potential
Detailed Description:
MOB015B is a topical solution for the treatment of nail fungus onychomycosis containing the active antifungal ingredient terbinafine Terbinafine is a well-known antifungal agent that has been widely used for decades for both in topical and oral preparations and is regarded as an effective treatment of dermatophyte infections In a phase II study MOB015B was found to be efficacious and safe in the topical treatment of distal subungual onychomycosis This Phase 1 study will assess the sensitization potential of MOB015B
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