What is CGB-600 studying for vitiligo?

CGB-600 is being studied to see if it can reduce the severity of vitiligo on the face and neck while monitoring safety. This trial compares CGB-600 to a non-active gel to evaluate its effects. The study is sponsored by CAGE Bio Inc. and aims to better understand treatment options for facial vitiligo.

Who may be eligible for this vitiligo clinical trial?

Adults aged 18 to 60 years with non-segmental vitiligo affecting the face or neck may be eligible. Participants must have stable vitiligo lesions present for at least 3 months and not be using other vitiligo treatments. Both males and females can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this vitiligo clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan for any travel costs they might incur.

Actively Recruiting

Phase 1

Age: 18Years - 60Years

All Genders

ID07357870

Phase 1 Study to Test Safety and Effectiveness of CGB-600 Gel for Treating Facial and Neck Vitiligo in Adults Aged 18 to 60

Led by CAGE Bio Inc. · Updated on 2026-01-22

Participants Needed

Research Sites

N/A

Total Duration

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 drugs 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

Age: 18Years - 60Years

All Genders

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

Research Team

Nitin Joshi, Ph.D.

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Phase 1 Study to Test Safety and Effectiveness of CGB-600 Gel for Treating Facial and Neck Vitiligo in Adults Aged 18 to 60

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria