Phase
Condition
Vitiligo
Treatment
placebo: gel vehicle
Drug: CGB-600 gel, experimental drug
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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.
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.
Vitiligo involvement ≤ 20% total body surface area (BSA).
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
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
Is not currently taking any medication for vitiligo in oral, topical, or any otherform, including over-the-counter (OTC) and/or cosmetic products
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)
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
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 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:
- Females who are pregnant, breastfeeding, or of childbearing potential and notpracticing reliable birth control
History of segmental or mixed vitiligo
Vitiligo affecting only external genitalia or hands/feet
History of skin cancer or pre-cancerous lesions in the treatment area
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
Use of biological, investigational, or experimental therapy 3 months beforeBaseline that could potentially interfere with the study participation or assessment
Known hypersensitivity to any components of the intervention or vehicle
History of melanocyte-keratinocyte transplantation procedure (MKTP) or othersurgical treatments for vitiligo
Uncontrolled thyroid function or other medical conditions that could interferewith study participation or assessment
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
Has demonstrated resistance to previous JAKi treatment, topical or systemic
Has clinically significant laboratory anomalies or vital signs, as judged by theinvestigator, that would interfere with the conduct or interpretation of studyresults
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
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
Is unable or unwilling to comply with any of the study requirements
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
Clinically significant alcohol or drug abuse, or history of poor cooperation orunreliability
Study Design
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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