Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment With 0.5% and 1% Tofacitnib for Tr… (NCT06810050) | Clinical Trial Compass
CompletedPhase 2
Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment With 0.5% and 1% Tofacitnib for Treatment of Atopic Dermatitis
United States180 participantsStarted 2024-12-18
Plain-language summary
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.
Who can participate
Age range12 Years
SexALL
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Inclusion 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.
✓
What they're measuring
1
Safety and tolerability
Timeframe: From enrollment to end of study at 8 weeks
2
evaluate effectiveness
Timeframe: From enrollment to end of study at 8 weeks
. Be able to follow trial instructions and likely to complete all required visits.
Exclusion criteria
✕. Females who are pregnant, breastfeeding, intending to be pregnant during the trial, or who do not agree to use an acceptable form of birth control during the trial if of childbearing potential .
✕. Immunocompromised individuals as adjudicated by the principal investigator (PI) based on review of medical history.
✕. Known hypersensitivity or previous allergic reaction to any constituent of the IP (e.g., tofacitinib or Janus kinase (JAK) inhibitors, essential oils, choline, phosphatidylcholine, glycerol, propylene glycol, polyethylene glycol).
✕. Has clinically significant safety labs (hematology, chemistry, and urinalysis) at the Screening visit that, in the opinion of the investigator, would preclude participation in the study or affect proper assessment of the study endpoints
✕. Skin infections (e.g., bacterial, fungal or viral) that can interfere with reliable AD assessments.
✕. Basal cell carcinoma within 6 months prior to Baseline.
✕. History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, uncontrolled diabetes, malignancy, or serious active or recurrent infection.
✕. Known hepatic impairment or disorder and/or ALT and AST \>3X ULN at Screening.