Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454747
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-06
Brief Title:
Randomized Study Using SM-030 Gel for Adults With Melasma
Sponsor:
DermBiont Inc
Organization:
DermBiont Inc
Study Overview
Official Title:
A Randomized Observer-Blinded Placebo-Controlled Study on the Safety and Efficacy of Twice Daily Application of SM-030 Gel 064 Vs SM-030 Gel 008 Vs Placebo Gel in Adults With Melasma
Status:
RECRUITING
Status Verified Date:
2024-08
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 is a phase 2b observer-blinded randomized study that will evaluate the safety and efficacy of topically applied SM-030 gel 064 and SM-030 gel 008 compared against placebo gel in healthy adult male and female subjects with Melasma The study will be comprised of a 12-week twice daily dosing period and a 4-week additional safety follow-up period Approximately 138 subjects who meet the eligibility criteria notably with a clinical diagnosis of Melasma will be randomized in a 321 ratio to one of three treatment arms SM-030 gel 064 N69 Placebo gel N46 or SM-030 gel 008 N23 Subjects will be competitively enrolled in Mexico and El Salvador across 5 sites 4 sites in Mexico and 1 in El Salvador Subjects will be assessed for safety and efficacy at each visit
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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