VitiligoPhase 1NCT07357870
A Proof of Concept, Phase 1 Study of CGB-600 for the Topical Treatment of Non-Segmented Facial Vitiligo
A Phase 1 study testing Drug: CGB-600 gel, experimental drug in people with Vitiligo, run by CAGE Bio Inc. at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Drug: CGB-600 gel, experimental drug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Jul 2025to 30 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
- -
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Ankara T.C. Ministry of Health
Ankara, Turkey, 06800
Sezin U Acikel, Assoc. Prof., +90 312 552 60 84, sezinunlu87@gmail.com
Sezin U Acikel, Assoc. Prof.
- Recruiting
Istanbul Universitesi faculty of Medicine
Istanbul, Turkey, 34116
Algun P Ekinci, Prof. Dr., +90 212 440 00 00 ext. 35014/35015, algun.ekinci@istanbul.edu.tr
Algun P Ekinci, Prof. Dr.
About this study
Official title: 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.
- Conditions
- Vitiligo
- Being tested
- Drug: CGB-600 gel, experimental drug, placebo: gel vehicle
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: CGB-600 gel, experimental drugDrug
experimental drug
placebo: gel vehicleOther
placebo gel
| Study group | Role | What they receive |
|---|---|---|
| CGB-600 gel | Experimental | Not described Receives: Drug: Drug: CGB-600 gel, experimental drug |
| vehicle gel | Placebo comparator | Not described Receives: Other: placebo: gel vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: Overall Incidence of tabulated safety events. [Time Frame: From enrollment to end of study at 24 weeks]
Measured: From enrollment to end of study at 24 weeks
Secondary outcomes (1)
evaluate effectiveness Percent of participants achieving ≥ 50% reduction in Facial Vitiligo Area Scoring Index (F-VASI) score in the treated target area from baseline at Week 24
Measured: from enrollment to end of study (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start25 Jul 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CAGE Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357870
- Sponsor's protocol ID
- CGB-600-02
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07357870
- Acronym / sponsor ID
- CGB-600-02
- Conditions
- Vitiligo
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- CAGE Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGB-600 gel | Experimental | Drug: Drug: CGB-600 gel, experimental drug |
| vehicle gel | Placebo comparator | Other: placebo: gel vehicle |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug: CGB-600 gel, experimental drugexperimental drug | Drug | CGB-600 gel |
| placebo: gel vehicleplacebo gel | Other | vehicle gel |
Primary outcome
Safety and tolerability: Overall Incidence of tabulated safety events. [Time Frame: From enrollment to end of study at 24 weeks]
Time frame: From enrollment to end of study at 24 weeks
1 secondary outcome
evaluate effectiveness Percent of participants achieving ≥ 50% reduction in Facial Vitiligo Area Scoring Index (F-VASI) score in the treated target area from baseline at Week 24
Time frame: from enrollment to end of study (24 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Drug: CGB-600 gel, experimental drug in people with Vitiligo, run by CAGE Bio Inc. at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nitin Joshi, Ph.D. (650-996-1845, njoshi@cagebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability: Overall Incidence of tabulated safety events. [Time Frame: From enrollment to end of study at 24 weeks] (time frame: From enrollment to end of study at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.