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New treatment option for Vitiligo
Official title A Proof of Concept, Phase 1 Study of CGB-600 for the Topical Treatment of Non-Segmented Facial Vitiligo
ClinicalTrials.gov ID: NCT07357870
What this study is testing
What is Drug: CGB-600 gel, experimental drug?
Drug: CGB-600 gel, experimental drug is an investigational medicine, given as an once-daily, being studied as a potential treatment for vitiligo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
- 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...
- 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...
- Stable disease, as judged by the investigator and patient report. Facial lesions must have been present ≤ 5 years with no new lesions or progression...
You likely can't join if
- 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...
- 7\. Use of biological, investigational, or experimental therapy 3 months before Baseline that could potentially interfere with the study...
See the full eligibility 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...
- 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...
- 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)...
- 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...
- 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...
- 18\. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability
The study team makes the final eligibility decision.
Where it's taking place
- Ankara, Turkey, Turkey (Türkiye)
- Istanbul, Turkey, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ankara, Turkey, Turkey (Türkiye); Istanbul, Turkey, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.