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CGB-400 for the Reduction of Facial Redness

Primary Purpose

Rosacea

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CGB-400
Sponsored by
CAGE Bio Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. Facial redness associated with rosacea.
  3. Facial redness (IGA-R) score of 2 or 3 (i.e., mild or moderate).
  4. Absence of any skin conditions that could interfere with the visual erythema assessments.
  5. 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).
  6. Willing to use the provided skincare regimen (e.g., face wash and moisturizer) over the duration of the study.
  7. Sign the IRB-approved ICF (which includes HIPAA) prior to any study-related procedures being performed.

Exclusion Criteria:

  1. Known hypersensitivity or previous allergic reaction to any constituent of the Investigational Products (i.e., essential oils, fragrance, choline, phosphatidylcholine, etc.).
  2. Any transient flushing syndrome.
  3. History of basal cell carcinoma within 6 months of Visit 1.
  4. 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.).
  5. Diagnosis of severe rosacea, ocular rosacea, rhinophymatous rosacea, or acne fulminans at Baseline.
  6. Blepharitis/meibomianitis requiring systemic treatment by an ophthalmologist.
  7. Uncontrolled systemic disease.
  8. Foreseen unprotected and intense/excessive UV exposure during the course of the study.

  9. 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
  10. Exposure to any other investigational drug/device within 30 days prior to study entry.

Sites / Locations

  • Cage Bio Investigative Site 1
  • Cage Bio Investigative Site 2
  • Cage Bio Investigative Site 3

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects with facial redness

Arm Description

Topical application twice daily for 4 weeks

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
Patient Global Assessment
5-point scale (0: excellent effectiveness; 1: good effectiveness; 2: Effective; 3: No significant benefit and 4: No benefit at all)
Bumps/Blemishes Count
Numerical count of Bumps/Blemishes

Full Information

First Posted
August 7, 2020
Last Updated
August 10, 2020
Sponsor
CAGE Bio Inc.
Collaborators
ethica Clinical Research Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04508660
Brief Title
CGB-400 for the Reduction of Facial Redness
Official Title
Effectiveness of CGB-400 (Cosmetic) for the Reduction of Facial Redness
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 26, 2018 (Actual)
Primary Completion Date
April 18, 2019 (Actual)
Study Completion Date
April 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CAGE Bio Inc.
Collaborators
ethica Clinical Research Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Open-label multicenter study using CGB-400 Gel (cosmetic) to reduce facial redness
Detailed Description
This is a Open-label multicenter study to evaluate the ability of CGB-400 Gel to reduce facial redness typically associated with rosacea. Approximately 25 subjects will be enrolled. Subjects will receive study treatment for 4 weeks and attend a total of 4 study visits (BL, W1, W2, W4).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects with facial redness
Arm Type
Experimental
Arm Description
Topical application twice daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
CGB-400
Intervention Description
BID application
Primary Outcome Measure Information:
Title
Investigator's Global Assessment of Redness (IGA-R)
Description
5-point scale (0: no redness; 1: slight redness; 2: Definite redness; 3: Marked redness and 4: Fiery redness)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Investigator's Global Assessment of Redness (IGA-R)
Description
5-point scale (0: no redness; 1: slight redness; 2: Definite redness; 3: Marked redness and 4: Fiery redness)
Time Frame
Day 0, Week 1, Week 2
Title
Patient Global Assessment
Description
5-point scale (0: excellent effectiveness; 1: good effectiveness; 2: Effective; 3: No significant benefit and 4: No benefit at all)
Time Frame
Week 1, Week 2, Week 4
Title
Bumps/Blemishes Count
Description
Numerical count of Bumps/Blemishes
Time Frame
Day 0, Week 1, Week 2, Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Facial redness (IGA-R) 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.
Facility Information:
Facility Name
Cage Bio Investigative Site 1
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Cage Bio Investigative Site 2
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Cage Bio Investigative Site 3
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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CGB-400 for the Reduction of Facial Redness

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