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

NCT04508205 | Completed Phase 1

• 1 other identifier: CGB-400-001a
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Rosacea

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Investigator's Global Assessment (IGA)

  Day 0, Week 2, Week 4, Week 8

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

  Day 0, Week 2, Week 4, Week 8

• Bumps/Blemishes Count

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

• Patient Global Assessment

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

Study Arms (1)

Subjects with redness and bumps and/or blemishes

EXPERIMENTAL

Topical administration twice daily for 12 weeks

Drug: CGB-400

Interventions

CGB-400 DRUG

BID application

Subjects with redness and bumps and/or blemishes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CAGE Bio Inc.: lead
• ethica Clinical Research Inc.: collaborator

Study Sites (3)

Cage Bio Investigative Site 1

Fremont, California, 94538, United States

Location

Cage Bio Investigative Site 2

San Diego, California, 92123, United States

Location

Cage Bio Investigative Site 3

Edgewater, Florida, 32132, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 11, 2020
• Study Start: October 26, 2018
• Primary Completion: April 18, 2019
• Study Completion: April 18, 2019
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)