Safety and Effectiveness of CGB-500 Topical Ointment with 0.5% and 1% Tofacitinib for the Treatment of Atopic Dermatitis: a Randomized, Dose-Ranging, Vehicle-Controlled, Double-Blind Trial
The goal of this clinical trial is to learn if CGB-500 works to treat atopic dermatitis in participants ages 12 and older. The goal is also to learn about the safety of CGB-500. The main questions it aims to answer are: Does CGB-500 improve atopic dermatitis by decreasing the area affected and the severity of the lesions? What medical problems do participants have when taking CGB500? Researchers will compare CGB-500 to a placebo (a look-alike substance that contains no drug) to see if CGB-500 works to treat atopic dermatitis. Participants will: Take CGB-500 or a placebo every day for 8 weeks. Visit the clinic once every 2 weeks for the first month and at the end of 8 weeks. Keep a diary of when they use the product and complete a form about their symptoms including itching.
⁃ To be eligible to participate in this trial, an individual must meet all of the following criteria:
• Outpatient, male or female of any race, 12 years of age or older. Females of childbearing potential (FOBCP) must have a negative urine pregnancy test at Screening and Baseline and practice a reliable method of contraception throughout the trial.
• Have a clinical diagnosis of atopic dermatitis (AD) for at least 12 months prior to Baseline that has been clinically stable disease for ≥ 3 months at the time of the screening visit and prior to dose administration and is confirmed to be AD according to the criteria of Hanifin and Rajka.
• Have an IGA (Investigator's Global Assessment) score of 2, 3, or 4 at Screening and Baseline.
• Have AD lesions/symptoms covering at least 1% but less than 10% of total BSA (excluding scalp, genitalia, palms, and soles) at Screening and Baseline.
• Have at least 1 target lesion that measures approximately 10 cm2 or more at Screening and Baseline. Lesion must be representative of the participant's disease state and not be located on the scalp, genitalia, palms, or soles.
• In general, good health as determined by medical history and physical examination at the time of screening (investigator discretion).
• Have peak pruritus numeric rating scale (PPNRS) score of ≥ 4 on the scale 0 to 10 at Screening and Baseline.
• Be able to follow trial instructions and likely to complete all required visits.
• Sign the institutional review board (IRB)-approved informed consent form (ICF, which includes HIPAA) and assent prior to any trial-related procedures being performed.