Actively Recruiting
A Proof of Concept, Phase 1 Study of CGB-600 for the Topical Treatment of Non-Segmented Facial Vitiligo
Led by CAGE Bio Inc. · Updated on 2026-01-22
36
Participants Needed
2
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if drug CGB-600 works to treat vitiligo on the face and neck in participants between 18-60 years of age. It will also learn about the safety of CGB-600. The main questions it aims to answer are: Does CGB-600 decrease the severity of vitiligo on the face and neck? What medical problems do participants have when taking drug CGB-600? Researchers will compare CGB-600 to a non-active drug (vehicle) to see if CGB-600 works to treat vitiligo. Participants will: Apply face twice daily for a period of 24 weeks. Visit the clinic 8 times for checkups and tests.
CONDITIONS
Official Title
A Proof of Concept, Phase 1 Study of CGB-600 for the Topical Treatment of Non-Segmented Facial Vitiligo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 60 years with a diagnosis of non-segmental vitiligo on the face or neck confirmed by dermoscopy and Wood's Lamp Examination
- Have 1 to 3 vitiligo lesions on the face or neck covering between 6 and 40 cm² with at least 75% depigmentation for at least 3 months
- Vitiligo affecting 20% or less of total body surface area
- In good health without diseases or conditions that could interfere with the study
- Stable vitiligo with facial lesions present no more than 5 years and no new lesions or worsening in the past 90 days
- Not currently taking any vitiligo medications, including over-the-counter or cosmetic products
- Agree to avoid other vitiligo treatments such as lights, lasers, or medical devices for 4 weeks before and during the study
- Agree not to use any lotions, creams, or topical products at the treatment site during the study unless directed
- Agree to provide informed consent
- Able to understand and follow study requirements
- Females of childbearing potential must have a negative pregnancy test and agree to use effective contraception or abstinence throughout the study
You will not qualify if you...
- Pregnant or breastfeeding females or females of childbearing potential not using reliable birth control
- History of segmental or mixed vitiligo
- Vitiligo only on external genitalia or hands/feet
- History of skin cancer or pre-cancerous lesions in the treatment area
- Use of topical or systemic vitiligo treatments within 4 weeks before baseline
- Active use of topical corticosteroids or immunomodulatory therapies on the face within 4 weeks before baseline
- Use of biological, investigational, or experimental therapies within 3 months that might interfere with the study
- Known allergy to any components of the study drug or placebo
- History of surgical treatments for vitiligo like melanocyte-keratinocyte transplantation
- Uncontrolled thyroid or other medical conditions affecting study participation
- Use of corticosteroids, UV therapies, Janus kinase inhibitors, or cytotoxic drugs within 4 weeks before baseline
- Resistance to previous Janus kinase inhibitor treatments
- Significant laboratory or vital sign abnormalities affecting study results
- Active skin diseases or inflammation on face or neck that would interfere with the study
- Participation in another clinical trial within 30 days before study start
- Unable or unwilling to follow study requirements
- Medical, psychiatric, or personal conditions increasing risk or interfering with study participation
- Significant alcohol or drug abuse or history of poor compliance
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Ankara T.C. Ministry of Health
Ankara, Turkey, Turkey (Türkiye), 06800
Actively Recruiting
2
Istanbul Universitesi faculty of Medicine
Istanbul, Turkey, Turkey (Türkiye), 34116
Actively Recruiting
Research Team
N
Nitin Joshi, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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