A Proof of Concept, Phase 1 Study of CGB-600 for the Topical Treatment of Non-Segmented Facial Vitiligo

Exclusion Criteria

• •1\. Females who are pregnant, breastfeeding, or of childbearing potential and not practicing reliable birth control
• •2\. History of segmental or mixed vitiligo
• •3\. Vitiligo affecting only external genitalia or hands/feet
• •4\. History of skin cancer or pre-cancerous lesions in the treatment area
• •5\. Past use of topical or systemic vitiligo treatments within 4 weeks (28 days) prior to Baseline 6. Current active use of topical corticosteroids on the face or immunomodulatory therapies within 4 weeks (28 days) prior to Baseline
• •7\. Use of biological, investigational, or experimental therapy 3 months before Baseline that could potentially interfere with the study participation or assessment
• •8\. Known hypersensitivity to any components of the intervention or vehicle
• •9\. History of melanocyte-keratinocyte transplantation procedure (MKTP) or other surgical treatments for vitiligo
• •10\. Uncontrolled thyroid function or other medical conditions that could interfere with study participation or assessment
• •11\. Use within 4 weeks (28 days) prior to Baseline (washout period) of 1) oral, intravenous or intralesional corticosteroids, 2) UVA/UVB therapy, 3) non-prescription UV light sources, 4) any oral or topical Janus kinase inhibitor (JAKi), or 5) cytotoxic drugs
• •12\. Has demonstrated resistance to previous JAKi treatment, topical or systemic
• •13\. Has clinically significant laboratory anomalies or vital signs, as judged by the investigator, that would interfere with the conduct or interpretation of study results
• •14\. Has any inflammations or any active skin diseases on the face and/or neck including complete leukotrichia or facial lesions that would interfere with study participation or assessment
• •15\. Is currently participating in another investigational medication or device study or has participated in a clinical trial within 30 days of the intended start of study treatment
• •16\. Is unable or unwilling to comply with any of the study requirements
• •17\. Has medical or psychiatric conditions or a personal situation that may increase the risk associated with study participation or may interfere with interpretation of study results or subject compliance and, in the opinion of the Principal Investigator (PI), makes the subject inappropriate for study entry
• •18\. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability