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

Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04508205
• Other study ID #: CGB-400-001a
• Status: Completed
• Phase: Phase 1
• Start date: October 26, 2018
• Est. completion date: April 18, 2019

Study information

• Verified date: August 2020
• Source: CAGE Bio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Open-label multicenter study using CGB-400 Gel to reduce facial redness, bumps, and blemishes.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 18, 2019
• Est. primary completion date: April 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 with or without bumps or blemishes.

3. Facial redness (IGA-R) score of 2 or 3 (i.e., mild or moderate).

4. IGA score of 2 or 3 (i.e., mild or moderate).

5. Absence of any skin conditions that could interfere with the visual erythema assessments.

6. 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).

7. Willing to use the provided skincare regimen (e.g., face wash and moisturizer) over the duration of the study.

8. 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.

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• CGB-400
BID application

Locations

Country	Name	City	State
United States	Cage Bio Investigative Site 3	Edgewater	Florida
United States	Cage Bio Investigative Site 1	Fremont	California
United States	Cage Bio Investigative Site 2	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
CAGE Bio Inc.	ethica Clinical Research Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Week 12
Primary	Investigator's Global Assessment of Redness (IGA-R)	5-point scale (0 - Clear skin with no signs of redness to 4 - Severe; fiery redness)	Week 12
Secondary	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)	Day 0, Week 2, Week 4, Week 8
Secondary	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)	Day 0, Week 2, Week 4, Week 8
Secondary	Bumps/Blemishes Count	Numerical count of Bumps/Blemishes	Day 0, Week 2, Week 4, Week 8, Week 12
Secondary	Patient Global Assessment	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