A Proof of Concept, Phase 1 Study of CGB-600 for the Topical Treatment of Non-Segmented Facial Vitiligo
ConditionVitiligo
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCAGE Bio Inc.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
1. Females who are pregnant, breastfeeding, or of childbearing potential and not practicing reliable birth control
Trial design
Treatments tested in this trial
- Drug: CGB-600 gel, experimental drug
- placebo: gel vehicle
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov