Phase 1 proof-of-concept test of CGB-600 gel for non-segmental vitiligo on the face and neck

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)

This trial will try a twice-daily CGB-600 gel to see if it reduces vitiligo on the face and neck in adults 18–60 and to check for side effects.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: CAGE Bio Inc. (Industry-sponsored)
• Locations: 2 sites (Ankara, Turkey and 1 other locations)
• Trial ID: NCT07357870 on ClinicalTrials.gov

What this trial studies

This is a phase 1, proof-of-concept interventional study comparing topical CGB-600 gel to a non-active vehicle applied twice daily for 24 weeks. Participants with 1–3 non-segmental facial or neck lesions meeting size and depigmentation criteria will be enrolled and evaluated at eight clinic visits. The study will monitor changes in lesion severity on the face/neck and collect safety and adverse event data. Researchers will compare outcomes between the CGB-600 and vehicle groups to determine initial signs of efficacy and tolerability.

Who should consider this trial

Good fit: Adults 18–60 with non-segmental facial or neck vitiligo having 1–3 lesions totaling 6–40 cm² with ≥75% depigmentation, ≤20% total body surface area involvement, stable disease, and not using other vitiligo treatments are ideal candidates.

Not a fit: People with segmental vitiligo, widespread disease over 20% BSA, unstable or rapidly progressing vitiligo, or who cannot stop other vitiligo treatments are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, CGB-600 could provide a new topical option to reduce depigmented patches on the face and neck.

How similar studies have performed: Topical therapies including JAK inhibitors have shown repigmentation in facial vitiligo, but CGB-600 is an investigational agent with limited prior human data.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. 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.
3. Vitiligo involvement ≤ 20% total body surface area (BSA).
4. 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
5. 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
6. Is not currently taking any medication for vitiligo in oral, topical, or any other form, including over-the-counter (OTC) and/or cosmetic products
7. 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)
8. 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
9. Agrees to review and sign a written informed consent form
10. Can understand and comply with the study requirements as judged by the investigator
11. 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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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

Where this trial is running

Ankara, Turkey and 1 other locations

• Ankara T.C. Ministry of Health — Ankara, Turkey, Turkey (Türkiye) (Recruiting)
• Istanbul Universitesi faculty of Medicine — Istanbul, Turkey, Turkey (Türkiye) (Recruiting)

Study contacts

• Study coordinator: Nitin Joshi, Ph.D.

Conditions Vitiligo