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

Last updated: January 21, 2026
Sponsor: CAGE Bio Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Vitiligo

Treatment

placebo: gel vehicle

Drug: CGB-600 gel, experimental drug

Clinical Study ID

NCT07357870
CGB-600-02
  • Ages 18-60
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult (18 to 60 years old) diagnosed with non-segmental vitiligo on the face orneck. Dermoscopy and a Wood's Lamp Examination should be performed to confirm thediagnosis.

  2. Facial and/or neck involvement with 1-3 vitiligo lesions (total combined area oflesions ≥ 6 cm² and ≤ 40 cm² and ≥75% depigmentation) for at least 3 months (90days) 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 constraintthat, 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 lesionsmust have been present ≤ 5 years with no new lesions or progression within 90 daysprior to Baseline

  6. Is not currently taking any medication for vitiligo in oral, topical, or any otherform, including over-the-counter (OTC) and/or cosmetic products

  7. Agrees to refrain from any other treatment modalities, including lights, lasers, orother 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 productsat the treatment site during the study treatment period unless directed to do so bythe 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 testand must agree to use a highly effective form of contraception or abstinence and bewilling to remain on that same method of birth control throughout the study.

Exclusion

Exclusion Criteria:

    1. Females who are pregnant, breastfeeding, or of childbearing potential and notpracticing reliable birth control
  1. History of segmental or mixed vitiligo

  2. Vitiligo affecting only external genitalia or hands/feet

  3. History of skin cancer or pre-cancerous lesions in the treatment area

  4. 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 orimmunomodulatory therapies within 4 weeks (28 days) prior to Baseline

  5. Use of biological, investigational, or experimental therapy 3 months beforeBaseline that could potentially interfere with the study participation or assessment

  6. Known hypersensitivity to any components of the intervention or vehicle

  7. History of melanocyte-keratinocyte transplantation procedure (MKTP) or othersurgical treatments for vitiligo

  8. Uncontrolled thyroid function or other medical conditions that could interferewith study participation or assessment

  9. 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

  10. Has demonstrated resistance to previous JAKi treatment, topical or systemic

  11. Has clinically significant laboratory anomalies or vital signs, as judged by theinvestigator, that would interfere with the conduct or interpretation of studyresults

  12. Has any inflammations or any active skin diseases on the face and/or neckincluding complete leukotrichia or facial lesions that would interfere with studyparticipation or assessment

  13. Is currently participating in another investigational medication or device studyor has participated in a clinical trial within 30 days of the intended start ofstudy treatment

  14. Is unable or unwilling to comply with any of the study requirements

  15. Has medical or psychiatric conditions or a personal situation that may increasethe risk associated with study participation or may interfere with interpretation ofstudy results or subject compliance and, in the opinion of the PrincipalInvestigator (PI), makes the subject inappropriate for study entry

  16. Clinically significant alcohol or drug abuse, or history of poor cooperation orunreliability

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: placebo: gel vehicle
Phase: 1
Study Start date:
July 25, 2025
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Ankara T.C. Ministry of Health

    Ankara 323786, Turkey 06800
    Turkey (Türkiye)

    Active - Recruiting

  • Istanbul Universitesi faculty of Medicine

    Istanbul 745044, Turkey 34116
    Turkey (Türkiye)

    Active - Recruiting

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