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CGB-400 for the Reduction of Facial Redness and Bumps and Blemishes

Primary Purpose

Rosacea

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CGB-400

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:

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.

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 redness and bumps and/or blemishes

Arm Description

Topical administration twice daily for 12 weeks

Outcomes

Primary Outcome Measures

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)

Investigator's Global Assessment of Redness (IGA-R)

5-point scale (0 - Clear skin with no signs of redness to 4 - Severe; fiery redness)

Secondary Outcome Measures

Investigator's Global Assessment (IGA)

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)

Bumps/Blemishes Count

Numerical count of Bumps/Blemishes

Patient Global Assessment

5-point scale (0: excellent effectiveness; 1: good effectiveness; 2: Effective; 3: No significant benefit and 4: No benefit at all)

Full Information

NCT ID

NCT04508205

First Posted

August 2, 2020

Last Updated

August 10, 2020

Sponsor

CAGE Bio Inc.

Collaborators

ethica Clinical Research Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04508205

Brief Title

CGB-400 for the Reduction of Facial Redness and Bumps and Blemishes

Official Title

Effectiveness of CGB-400 (Cosmetic) for the Reduction of Facial Redness and Bumps and Blemishes

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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).

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

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subjects with redness and bumps and/or blemishes

Arm Type

Experimental

Arm Description

Topical administration twice daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

CGB-400

Intervention Description

BID application

Primary Outcome Measure Information:

Title

Investigator's Global Assessment (IGA)

Description

Time Frame

Week 12

Title

Investigator's Global Assessment of Redness (IGA-R)

Description

5-point scale (0 - Clear skin with no signs of redness to 4 - Severe; fiery redness)

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Investigator's Global Assessment (IGA)

Description

Time Frame

Day 0, Week 2, Week 4, Week 8

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 2, Week 4, Week 8

Title

Bumps/Blemishes Count

Description

Numerical count of Bumps/Blemishes

Time Frame

Day 0, Week 2, Week 4, Week 8, Week 12

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

Day 0, Week 2, Week 4, Week 8, Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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.

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

Learn more about this trial

CGB-400 for the Reduction of Facial Redness and Bumps and Blemishes

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