RosaceaPhase 1NCT04508205
CGB-400 for the Reduction of Facial Redness and Bumps and Blemishes
A Phase 1 study testing CGB-400 in people with Rosacea, run by CAGE Bio Inc. at 3 sites in United States.
Trial summary
Open-label multicenter study using CGB-400 Gel to reduce facial redness, bumps, and blemishes. 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?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Oct 2018to 18 Apr 2019
- Phase
- Phase 1
- 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.
- Facial redness associated with rosacea with or without bumps or blemishes.
- Facial redness (IGA-R) score of 2 or 3 (i.e., mild or moderate).
- IGA score of 2 or 3 (i.e., mild or moderate).
- Absence of any skin conditions that could interfere with the visual erythema assessments.
- Willing to forego any other topical or non-topical treatment 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 and moisturizer) over the duration of the study.
- Sign the IRB-approved ICF (which includes HIPAA) prior to any study-related procedures being performed.
Who cannot join
- Known hypersensitivity or previous allergic reaction to any constituent of the Investigational Products (i.e., essential oils, fragrance, choline, phosphatidylcholine, etc.).
- Any transient flushing syndrome.
- History of basal cell carcinoma within 6 months of Visit 1.
- 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.).
- Diagnosis of severe rosacea, ocular rosacea, rhinophymatous rosacea, or acne fulminans at Baseline.
- Blepharitis/meibomianitis requiring systemic treatment by an ophthalmologist.
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- Uncontrolled systemic disease.
- Foreseen unprotected and intense/excessive UV exposure during the course of the study.
- Use of any of the following concomitant medications/procedures:
- Cosmetic and/or OTC products for redness reduction and/or skin clearing
- Topical medications for rosacea
- Systemic antibiotics or corticosteroids
- Topical antibiotics, corticosteroids, or antiparasitic agents
- Intense/excessive ultraviolet (UV) radiation
- Phototherapy, energy-based therapy, facials, chemical peels, microdermabrasion
- Exposure to any other investigational drug/device within 30 days prior to study entry.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cage Bio Investigative Site 3
Edgewater, Florida, 32132
Cage Bio Investigative Site 1
Fremont, California, 94538
Cage Bio Investigative Site 2
San Diego, California, 92123
About this study
Official title: Effectiveness of CGB-400 (Cosmetic) for the Reduction of Facial Redness and Bumps and Blemishes
Open-label multicenter study using CGB-400 Gel to reduce facial redness, bumps, and blemishes.
Read the detailed description
This is a Open-label multicenter study to evaluate the ability of CGB-400 Gel to reduce facial redness and bumps/blemishes typically associated with rosacea. Approximately 25 subjects will be enrolled.
Subjects will receive study treatment for 12 weeks and attend a total of 5 study visits (i.e., BL, W2, W4, W8, W12).
- Conditions
- Rosacea
- Being tested
- CGB-400
- 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
BID application
| Study group | Role | What they receive |
|---|---|---|
| Subjects with redness and bumps and/or blemishes | Experimental | Topical administration twice daily for 12 weeks Receives: Drug: CGB-400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Assessment (IGA)
5-point scale (0 - Clear skin with no signs of bumps/blemishes; 1 - Almost clear; minimal lesions (<5 bumps/blemishes); 2 - Mild facial lesions (6-10 bumps/blemishes): 3 - Moderate lesions; marked redness (11-25 bumps/blemishes): 4 - Severe lesions; fiery redness (>25 bumps/blemishes)
Measured: Week 12
Investigator's Global Assessment of Redness (IGA-R)
5-point scale (0 - Clear skin with no signs of redness to 4 - Severe; fiery redness)
Measured: Week 12
Secondary outcomes (4)
Investigator's Global Assessment (IGA)
5-point scale (0 - Clear skin with no signs of bumps/blemishes; 1 - Almost clear; minimal lesions (<5 bumps/blemishes); 2 - Mild facial lesions (6-10 bumps/blemishes): 3 - Moderate lesions; marked redness (11-25 bumps/blemishes): 4 - Severe lesions; fiery redness (>25 bumps/blemishes)
Measured: Day 0, Week 2, Week 4, Week 8
Investigator's Global Assessment of Redness (IGA-R)
5-point scale (0: no redness; 1: slight redness; 2: Definite redness; 3: Marked redness and 4: Fiery redness)
Measured: Day 0, Week 2, Week 4, Week 8
Bumps/Blemishes Count
Numerical count of Bumps/Blemishes
Measured: Day 0, Week 2, Week 4, Week 8, Week 12
Patient Global Assessment
5-point scale (0: excellent effectiveness; 1: good effectiveness; 2: Effective; 3: No significant benefit and 4: No benefit at all)
Measured: Day 0, Week 2, Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start26 Oct 2018
- Primary completion18 Apr 2019
- Study completion18 Apr 2019
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 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
- NCT04508205
- Sponsor's protocol ID
- CGB-400-001a
- Status last verified
- Aug 2020
- First submitted
- 2 Aug 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of CGB-400 (Cosmetic) for the Reduction of Facial Redness and Bumps and Blemishes
- ClinicalTrials.gov ID
- NCT04508205
- Acronym / sponsor ID
- CGB-400-001a
- Conditions
- Rosacea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- CAGE Bio Inc.Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 18 Apr 2019 (actual)
- First posted
- 11 Aug 2020 (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.
Open-label multicenter study using CGB-400 Gel to reduce facial redness, bumps, and blemishes.
Detailed description
This is a Open-label multicenter study to evaluate the ability of CGB-400 Gel to reduce facial redness and bumps/blemishes typically associated with rosacea. Approximately 25 subjects will be enrolled.
Subjects will receive study treatment for 12 weeks and attend a total of 5 study visits (i.e., BL, W2, W4, W8, W12).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with redness and bumps and/or blemishes | Experimental | Drug: CGB-400Topical 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.
- Facial redness associated with rosacea with or without bumps or blemishes.
- Facial redness (IGA-R) score of 2 or 3 (i.e., mild or moderate).
- IGA score of 2 or 3 (i.e., mild or moderate).
- Absence of any skin conditions that could interfere with the visual erythema assessments.
Key exclusion criteria (16 listed)
- Known hypersensitivity or previous allergic reaction to any constituent of the Investigational Products (i.e., essential oils, fragrance, choline, phosphatidylcholine, etc.).
- Any transient flushing syndrome.
- History of basal cell carcinoma within 6 months of Visit 1.
- 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.).
- Diagnosis of severe rosacea, ocular rosacea, rhinophymatous rosacea, or acne fulminans at Baseline.
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-400BID application | Drug | Subjects with redness and bumps and/or blemishes |
Primary outcome
Investigator's Global Assessment (IGA)
Time frame: Week 12
5-point scale (0 - Clear skin with no signs of bumps/blemishes; 1 - Almost clear; minimal lesions (<5 bumps/blemishes); 2 - Mild facial lesions (6-10 bumps/blemishes): 3 - Moderate lesions; marked redness (11-25 bumps/blemishes): 4 - Severe lesions; fiery redness (>25 bumps/blemishes)
Investigator's Global Assessment of Redness (IGA-R)
Time frame: Week 12
5-point scale (0 - Clear skin with no signs of redness to 4 - Severe; fiery redness)
4 secondary outcomes
Investigator's Global Assessment (IGA)
Time frame: Day 0, Week 2, Week 4, Week 8
Investigator's Global Assessment of Redness (IGA-R)
Time frame: Day 0, Week 2, Week 4, Week 8
Bumps/Blemishes Count
Time frame: Day 0, Week 2, Week 4, Week 8, Week 12
Patient Global Assessment
Time frame: Day 0, Week 2, Week 4, Week 8, 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 12 Aug 2020.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CGB-400 in people with Rosacea, run by CAGE Bio Inc. at 3 sites 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 16 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 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Investigator's Global Assessment (IGA) (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 12 Aug 2020.