Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:09 PM
Study NCT ID:
NCT06923228
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-11
First Post:
2025-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Efficacy and Safety of CGB-500, 1% Tofacitinib Versus an Active Comparator for Atopic Dermatitis
Sponsor:
CAGE Bio Inc.
Organization:
Study Overview
Official Title:
A Single-Blind, Prospective Clinical Study to Assess the Efficacy, Safety and Tolerability of CGB-500 1% Tofacitinib Ointment vs. an Active Comparator for Atopic Dermatitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
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 goal of this clinical trial is to learn if drug CGB-500 works to treat atopic dermatitis in subjects 12 years of age or older. It will also learn about the safety of CGB-500. The main questions it aims to answer are:
Does CGB-500 decrease the severity of atopic dermatitis on the skin? What medical problems do participants have when taking drug CGB-500? Researchers will compare CGB-500 to a an approved product (1.5% ruxolitinib) to see if CGB-500 works to treat atopic dermatitis.
Participants will:
Apply CGB-500 and ruxolitinib to different locations on their body twice a day for four weeks.
Visit the clinic six times for checkups and tests Keep a diary of their symptoms and when they apply the product
Does CGB-500 decrease the severity of atopic dermatitis on the skin? What medical problems do participants have when taking drug CGB-500? Researchers will compare CGB-500 to a an approved product (1.5% ruxolitinib) to see if CGB-500 works to treat atopic dermatitis.
Participants will:
Apply CGB-500 and ruxolitinib to different locations on their body twice a day for four weeks.
Visit the clinic six times for checkups and tests Keep a diary of their symptoms and when they apply the product
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: