Actively Recruiting
Safety and Effectiveness of CGB-600 Gel for the Treatment of Non-Segmental Facial Vitiligo: A Randomized, Double-Blind, Vehicle-Controlled Phase 1 Proof of Concept Study
Led by CAGE Bio Inc. · Updated on 2026-01-22
36
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying vitiligo, a condition that causes loss of skin color, focused on the face and neck areas in adults aged 18 to 60 years. The study aims to evaluate whether the drug CGB-600 can reduce the severity of vitiligo in these areas and to monitor its safety. Participants will be randomly assigned to receive either the drug or a non-active gel (vehicle) in a double-blind setup to compare effects. Participants will apply the CGB-600 gel or the vehicle gel twice daily to the affected facial and neck areas for 24 weeks. The study includes eight clinic visits for checkups and tests throughout the treatment period. This is a phase 1 proof of concept trial designed to assess initial safety and effectiveness. During the study, participants will undergo regular assessments including safety monitoring for any medical issues and evaluation of vitiligo severity using the Facial Vitiligo Area Scoring Index (F-VASI). The study tracks safety events from enrollment through the 24-week treatment. Participants must comply with study instructions and attend scheduled visits over the 24 weeks to support thorough evaluation of the drug's impact and safety profile.
CONDITIONS
Brief 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 diagnosed with non-segmental vitiligo on the face or neck confirmed by dermoscopy and Wood's Lamp examination
- Having 1 to 3 vitiligo lesions on the face or neck with a combined area between 6 and 40 cm² and at least 75% depigmentation for at least 3 months prior to baseline
- Vitiligo involvement covering 20% or less of total body surface area
- Otherwise in good health without conditions that might interfere with the study
- Stable vitiligo with facial lesions present for 5 years or less and no new lesions or progression within 90 days before baseline
- Not currently using any oral, topical, or other vitiligo treatments including OTC or cosmetic products
- Agree to avoid other vitiligo treatments, lights, lasers, or devices for 4 weeks before and during the study
- Agree to avoid using lotions or topical products on the treatment site during the study unless instructed
- Able to understand and comply with study requirements and provide written informed consent
- 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...
- Females who are pregnant, breastfeeding, or of childbearing potential not using reliable birth control
- History of segmental or mixed vitiligo
- Vitiligo affecting only 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
- Current use of topical corticosteroids on the face or immunomodulatory therapies within 4 weeks before baseline
- Use of biological, investigational, or experimental therapies within 3 months before baseline
- Known allergy to any components of the study drug or vehicle
- History of melanocyte-keratinocyte transplantation or other surgical vitiligo treatments
- Uncontrolled thyroid or other medical conditions that may interfere with study participation
- Use of corticosteroids, UV therapies, Janus kinase inhibitors, or cytotoxic drugs within 4 weeks before baseline
- Resistance to previous Janus kinase inhibitor treatment
- Significant lab abnormalities or vital signs that interfere with study results
- Active skin diseases or inflammations on face or neck that interfere with study
- Participation in another clinical trial within 30 days before study start
- Inability or unwillingness to comply with study requirements
- Medical or psychiatric conditions or personal situations increasing risk or interfering with participation
- Significant alcohol or drug abuse or history of poor cooperation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants apply the study gel (either CGB-600 or placebo) topically to facial vitiligo lesions.
Regular visits during the 24-week treatment period
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.
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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