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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Inflammatory Lesion Count

Timeframe: Week 12

Investigator Global Assessment (IGA)

Timeframe: Week 12

Trial details

NCT IDNCT04886739

SponsorCAGE Bio Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-22

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