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 (Study No. CGB-600-02)
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.
• Adult (18 to 60 years old) diagnosed with non-segmental vitiligo on the face or neck. Dermoscopy and a Wood's Lamp Examination should be performed to confirm the diagnosis.
• Facial and/or neck involvement with 1-3 vitiligo lesions (total combined area of lesions ≥ 6 cm² and ≤ 40 cm² and ≥75% depigmentation) for at least 3 months (90 days) prior to Baseline.
• Vitiligo involvement ≤ 20% total body surface area (BSA).
• Is otherwise in good health and free from any disease, condition, or constraint that, in the Investigator's opinion, might interfere with the conduct of the study
• Stable disease, as judged by the investigator and patient report. Facial lesions must have been present ≤ 5 years with no new lesions or progression within 90 days prior to Baseline
• Is not currently taking any medication for vitiligo in oral, topical, or any other form, including over-the-counter (OTC) and/or cosmetic products
• Agrees to refrain from any other treatment modalities, including lights, lasers, or other medical devices, prescription or otherwise, for vitiligo for 4 weeks (28 days) before and during the study treatment (see Table 5.1 for complete list)
• Agrees to refrain from using any lotions, creams, liquids, or other topical products at the treatment site during the study treatment period unless directed to do so by the investigator
• Agrees to review and sign a written informed consent form
⁃ Can understand and comply with the study requirements as judged by the investigator
⁃ Females of childbearing potential (FOCBP) must have a negative urine pregnancy test and must agree to use a highly effective form of contraception or abstinence and be willing to remain on that same method of birth control throughout the study.
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