CGB-400 for the Reduction of Facial Redness

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

Open-label multicenter study using CGB-400 Gel (cosmetic) to reduce facial redness

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: CGB-400

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).

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Cage Bio Investigative Site 1
    • San Diego, California, United States, 92123
      • Cage Bio Investigative Site 2
  • Florida
    • Edgewater, Florida, United States, 32132
      • Cage Bio Investigative Site 3

Participation Criteria

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects with facial redness; Topical application twice daily for 4 weeks	Drug: CGB-400; BID application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: CAGE Bio Inc.
• Collaborators: ethica Clinical Research Inc.

Study record dates

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 7, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 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: Skin Diseases; Rosacea
• Other Study ID Numbers: CGB-400-001b

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