- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04508205
CGB-400 for the Reduction of Facial Redness and Bumps and Blemishes
August 10, 2020 updated by: CAGE Bio Inc.
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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Fremont, California, United States, 94538
- Cage Bio Investigative Site 1
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San Diego, California, United States, 92123
- Cage Bio Investigative Site 2
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Florida
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Edgewater, Florida, United States, 32132
- Cage Bio Investigative Site 3
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Subjects with redness and bumps and/or blemishes
Topical administration twice daily for 12 weeks
|
BID application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Week 12
|
Investigator's Global Assessment of Redness (IGA-R)
Time Frame: Week 12
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5-point scale (0 - Clear skin with no signs of redness to 4 - Severe; fiery redness)
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Investigator's Global Assessment (IGA)
Time Frame: Day 0, Week 2, Week 4, Week 8
|
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)
|
Day 0, Week 2, Week 4, Week 8
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Investigator's Global Assessment of Redness (IGA-R)
Time Frame: Day 0, Week 2, Week 4, Week 8
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5-point scale (0: no redness; 1: slight redness; 2: Definite redness; 3: Marked redness and 4: Fiery redness)
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Day 0, Week 2, Week 4, Week 8
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Bumps/Blemishes Count
Time Frame: Day 0, Week 2, Week 4, Week 8, Week 12
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Numerical count of Bumps/Blemishes
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Day 0, Week 2, Week 4, Week 8, Week 12
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Patient Global Assessment
Time Frame: Day 0, Week 2, Week 4, Week 8, Week 12
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5-point scale (0: excellent effectiveness; 1: good effectiveness; 2: Effective; 3: No significant benefit and 4: No benefit at all)
|
Day 0, Week 2, Week 4, Week 8, Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 26, 2018
Primary Completion (Actual)
April 18, 2019
Study Completion (Actual)
April 18, 2019
Study Registration Dates
First Submitted
August 2, 2020
First Submitted That Met QC Criteria
August 7, 2020
First Posted (Actual)
August 11, 2020
Study Record Updates
Last Update Posted (Actual)
August 12, 2020
Last Update Submitted That Met QC Criteria
August 10, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CGB-400-001a
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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