Clinical trial NCT04508205: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rosacea
Lead sponsor: CAGE Bio Inc.
Sponsor class: INDUSTRY
Collaborators: name: ethica Clinical Research Inc.
First posted: 2020-08-11
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Investigator's Global Assessment (IGA)
timeFrame: Week 12
measure: Investigator's Global Assessment of Redness (IGA-R)
timeFrame: Week 12
Secondary outcomes:
measure: Investigator's Global Assessment (IGA)
timeFrame: Day 0, Week 2, Week 4, Week 8
measure: Investigator's Global Assessment of Redness (IGA-R)
timeFrame: Day 0, Week 2, Week 4, Week 8
measure: Bumps/Blemishes Count
timeFrame: Day 0, Week 2, Week 4, Week 8, Week 12
measure: Patient Global Assessment
timeFrame: Day 0, Week 2, Week 4, Week 8, Week 12
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Cage Bio Investigative Site 1
state: California
city: San Diego
country: United States
facility: Cage Bio Investigative Site 2
state: California
city: Edgewater
country: United States
facility: Cage Bio Investigative Site 3
state: Florida
Study officials:
References: