Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment With 0.5% and 1% Tofacitnib for Treatment of Atopic Dermatitis

Part of paid clinical trials in Fremont, California.

Sponsor
CAGE Bio Inc.
Study ID
NCT06810050
Phase
PHASE2
Status
Completed

Conditions

  • Atopic Dermatitis (AD)

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The goal of this clinical trial is to learn if CGB-500 works to treat atopic dermatitis in participants ages 12 and older. The goal is also to learn about the safety of CGB-500. The main questions it aims to answer are: Does CGB-500 improve atopic dermatitis by decreasing the area affected and the severity of the lesions? What medical problems do participants have when taking CGB500? Researchers will compare CGB-500 to a placebo (a look-alike substance that contains no drug) to see if CGB-500 works to treat atopic dermatitis. Participants will: Take CGB-500 or a placebo every day for 8 weeks. Visit the clinic once every 2 weeks for the first month and at the end of 8 weeks. Keep a diary of when they use the product and complete a form about their symptoms including itching.

Key Dates

Start date
Dec 18, 2024
Status verified
Mar 2026
Primary completion
Aug 30, 2025
Completion
Oct 30, 2025

Study Design

Enrollment
180 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CGB 500 ointment with 0.5% tofacitinib
  • Experimental: CGB 500 ointment with 1% tofacitinib
  • Placebo Comparator: vehicle ointment

Primary Outcome Measure

Safety and tolerability [ Time Frame: From enrollment to end of study at 8 weeks ]

Locations (16)

FacilityCityStateZIPSite coordinators
Center for Dermatology Clinical Research Inc.FremontCalifornia94538-
Ablon Skin Institute and Research CenterManhattan BeachCalifornia90266-
TCR Medical CorporationSan DiegoCalifornia92123-
Syrentis Clinical ResearchSanta AnaCalifornia92705-
USA and International Research Inc.DoralFlorida33126-
FXM Clinical ResearchFort LauderdaleFlorida33308-
Driven ResearchGablesFlorida33134-
FXM Clinical Research Miami, LLCMiamiFlorida33175-
FXM Clinical Research Miramar, LLCMiramarFlorida33027-
Cordova Research InstituteSweetwaterFlorida33182-
The Indiana Clinical Trials Center, PCPlainfieldIndiana46168-
Metro Boston Clinical PartnersBrightonMassachusetts02135-
J&S Studies, Inc.New BrightonMinnesota55112-
JDR Dermatology ResearchLas VegasNevada89148-
Tennessee Clinical Research CenterNashvilleTennessee37215-
DermResearchAustinTexas78759-

Find similar trials in Fremont, CA

By research site
Center for Dermatology Clinical Research Inc.· Fremont, CAAblon Skin Institute and Research Center· Manhattan Beach, CATCR Medical Corporation· San Diego, CASyrentis Clinical Research· Santa Ana, CAUSA and International Research Inc.· Doral, FLFXM Clinical Research· Fort Lauderdale, FL

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