CGB-400 Topical Gel for the Treatment of Inflammatory Lesions of Rosacea (NCT04886739) | Clinical Trial Compass
CompletedPhase 2
CGB-400 Topical Gel for the Treatment of Inflammatory Lesions of Rosacea
United States78 participantsStarted 2021-05-07
Plain-language summary
This is a multicenter, randomized, double-blind, vehicle-controlled, parallel design study evaluating the efficacy and safety of CGB-400 Topical Gel for the treatment of inflammatory lesions of rosacea. The study consists of a 12-week double-blind treatment period with clinic visits at Baseline (Day 0), and Weeks 2, 4, 8, and 12.
Approximately 80 subjects will be enrolled and randomized at a 1:1 ratio to treatment with either CGB-400 Topical Gel (40%) BID or Vehicle Gel BID.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative UPT at Baseline and practice a reliable method of contraception throughout the study.
* Clinical diagnosis of papulopustular facial rosacea.
* Investigator Global Assessment (IGA) score of 3 or 4 (i.e., moderate or severe).
* Facial inflammatory lesion count (i.e., papules and pustules) of ≥15 and ≤50 (excluding lesions involving the eyes and scalp) with ≤2 nodules.
* Willing to forego any other topical or non-topical treatment, cosmetic, OTC, or prescription on the study areas during treatment (other than sun protection or the study specified face wash and moisturizer).
* Willing to use the provided skincare regimen (e.g., face wash, moisturizer) during the study.
* In general good health as determined by medical history and physical examination at the time of screening (Investigator discretion).
* Sign the IRB-approved ICF (which includes HIPAA) prior to any study-related procedures being performed.
Exclusion Criteria:
* Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control (as specified in Section 5.1).
* Known hypersensitivity or previous allergic reaction to any constituent of the Investigational Product (i.e., essential oils, fragrance, choline, phosphatidylcholine, propylene glycol, limonene, cellulose).
* Any transient flushing syndrome.
* Particular…