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

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)

Overview

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.

Interventions

• Drug Drug: CGB-600 gel, experimental drug
  experimental drug
• Other placebo: gel vehicle
  placebo gel

Primary outcome measures

• 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]

Secondary outcome measures (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 [Time frame: from enrollment to end of study (24 weeks)]

Eligibility criteria

Inclusion criteria

• 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
• 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.

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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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 2 centers

• Ankara T.C. Ministry of Health — Ankara
• Istanbul Universitesi faculty of Medicine — Istanbul

Identifiers

NCT: NCT07357870 · CGB-600-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗