RosaceaPhase 2NCT04886739
CGB-400 Topical Gel for the Treatment of Inflammatory Lesions of Rosacea
A Phase 2 study testing CGB-400 in people with Rosacea, run by CAGE Bio Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea
- What is being tested?
- CGB-400
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2021to 22 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cage Bio Investigative Site 1
Fremont, California, 94538
About this study
Official title: Safety and Effectiveness of CGB-400 Topical Gel for the Treatment of Inflammatory Lesions of Rosacea: A Randomized, Double-Blind, Vehicle-Controlled Proof of Concept Study
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.
- Conditions
- Rosacea
- Being tested
- CGB-400, Vehicle Gel
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGB-400Drug
Topical gel
Vehicle GelDrug
Topical gel
| Study group | Role | What they receive |
|---|---|---|
| CGB-400 Topical Gel | Experimental | Topical administration twice daily for 12 weeks Receives: Drug: CGB-400 |
| Vehicle Gel | Placebo comparator | Topical administration twice daily for 12 weeks Receives: Drug: Vehicle Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Lesion Count
Numerical count of inflammatory lesions (pustules and papules)
Measured: Week 12
Investigator Global Assessment (IGA)
- 0 - Clear; No inflammatory lesions present; at most mild erythema
- 1 - Almost clear; Very mild erythema present. Very few small papules/pustules
- 2 - Mild; Mild erythema. Several small papules/pustules
- 3 - Moderate; Moderate erythema. Several small or large papules/pustules
- 4 - Severe; Severe erythema. Numerous small and/or large papules/pustules
Measured: Week 12
Secondary outcomes (3)
Inflammatory Lesion Count
Numerical count of inflammatory lesions (pustules and papules)
Measured: Weeks 2, 4, and 8
Investigator Global Assessment (IGA)
- 0 - Clear; No inflammatory lesions present; at most mild erythema
- 1 - Almost clear; Very mild erythema present. Very few small papules/pustules
- 2 - Mild; Mild erythema. Several small papules/pustules
- 3 - Moderate; Moderate erythema. Several small or large papules/pustules
- 4 - Severe; Severe erythema. Numerous small and/or large papules/pustules
Measured: Weeks 2, 4, and 8
Rosacea Quality of Life (RosaQoL) Questionnaire
Patient Reported Outcome
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start7 May 2021
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAGE Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886739
- Sponsor's protocol ID
- CGB-400-002
- Status last verified
- Aug 2022
- First submitted
- 30 Apr 2021
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of CGB-400 Topical Gel for the Treatment of Inflammatory Lesions of Rosacea: A Randomized, Double-Blind, Vehicle-Controlled Proof of Concept Study
- ClinicalTrials.gov ID
- NCT04886739
- Acronym / sponsor ID
- CGB-400-002
- Conditions
- Rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- CAGE Bio Inc.Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Study start
- 7 May 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGB-400 Topical Gel | Experimental | Drug: CGB-400Topical administration twice daily for 12 weeks |
| Vehicle Gel | Placebo comparator | Drug: Vehicle GelTopical administration twice daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGB-400Topical gel | Drug | CGB-400 Topical Gel |
| Vehicle GelTopical gel | Drug | Vehicle Gel |
Primary outcome
Inflammatory Lesion Count
Time frame: Week 12
Numerical count of inflammatory lesions (pustules and papules)
Investigator Global Assessment (IGA)
Time frame: Week 12
* 0 - Clear; No inflammatory lesions present; at most mild erythema * 1 - Almost clear; Very mild erythema present. Very few small papules/pustules * 2 - Mild; Mild erythema. Several small papules/pustules * 3 - Moderate; Moderate erythema. Several small or large papules/pustules * 4 - Severe; Severe erythema. Numerous small and/or large papules/pustules
3 secondary outcomes
Inflammatory Lesion Count
Time frame: Weeks 2, 4, and 8
Investigator Global Assessment (IGA)
Time frame: Weeks 2, 4, and 8
Rosacea Quality of Life (RosaQoL) Questionnaire
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
Related trials for Rosacea
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Enrolling by invitation
Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions
Rosacea, Vascular Diseases
RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Recruiting
Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
RecruitingObservational study
Determinants of Chronic Inflammatory Skin Disease Trajectories
Atopic Dermatitis, Psoriasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CGB-400 in people with Rosacea, run by CAGE Bio Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Lesion Count (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.