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A Proof of Concept, Phase 1 Study of CGB-600 for the Topical Treatment of Non-Segmented Facial Vitiligo | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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)

NCT07357870•CAGE Bio Inc.

View on ClinicalTrials.gov

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

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

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
+7 more criteria

Locations (2)

Ankara T.C. Ministry of Health

Ankara, Turkey, Turkey (Türkiye)

Istanbul Universitesi faculty of Medicine

Istanbul, Turkey, Turkey (Türkiye)

Key Dates

Start Date

July 25, 2025

Primary Completion Date

November 30, 2026

Completion Date

November 30, 2026

Last Updated

January 22, 2026

Enrollment

ESTIMATED participants

Conditions

Vitiligo

Interventions

Drug: CGB-600 gel, experimental drug

DRUG

placebo: gel vehicle

OTHER

Contacts

Nitin Joshi, Ph.D.

CONTACT

650-996-1845 njoshi@cagebio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo

Effectiveness of Micro-needling With 5 Fluorouracil Versus Potent Topical Steroids in the Treatment of Limited Vitiligo

Betamethasone Phonophoresis For Vitiligo

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