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New gel shows promise for rosacea Flare-Ups

NCT ID NCT04886739

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a topical gel called CGB-400 in 78 adults with moderate to severe rosacea. Participants applied the gel or a placebo twice daily for 12 weeks. Researchers counted inflammatory lesions and assessed skin clarity to see if the gel reduces symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CGB-400 topical gel
What this could lead to
If it works, this could offer a new topical option to reduce redness and bumps in people with rosacea.
What could go wrong
This is a small, early-phase proof-of-concept study. The gel may not work better than a placebo, and results may not apply to all rosacea patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

78 people

The number who actually took part.

Started

May 2021

Finished

Dec 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 forms of rosacea (ocular rosacea, rosacea conglobata, rosacea fulminans, isolated rhinophyma, granulomatous rosacea, phymatous rosacea, plaque-type rosacea lesions isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia. * Papulopustular rosacea that had required systemic treatment within the past 12 months. * Facial skin conditions that can interfere with reliable rosacea assessments (e.g., keloids, hypertrophic scarring, dense telangiectasia, plaque-like facial edema, recent facial surgery, etc.). * Facial dermatoses that may be confounded with papulopustular rosacea (e.g., perioral dermatitis, facial keratosis pilaris, seborrheic dermatitis, acne fulminans, etc.). * History or presence of a skin condition/disease that is located in the treatment area(s) and might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, psoriasis, significant actinic damage, vitiligo, open wounds, infection, etc.). * Basal cell carcinoma within 6 months of Visit 1. * Uncontrolled systemic disease. * Foreseen unprotected and intense/excessive UV exposure during the course of the study. * Use of prohibited concomitant medications/procedures, as specified below in Table 1, during the study or within the defined washout periods. * Scheduled or planned surgical procedures during the course of the study. * Unable or unwilling to comply with any of the study requirements. * Medical or psychiatric conditions, or a personal situation, that may increase the risk associated with study participation or may interfere with interpretation of study results or subject compliance and, in the opinion of the PI, makes the subject inappropriate for study entry. * Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability. * Exposure to any other investigational drug/device within 30 days prior to study entry

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cage Bio Investigative Site 1

    Fremont, California, 94538, United States

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Other studies related to the condition(s) this trial covers.