NCT04508660

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

August 7, 2020

Last Update Submit

August 10, 2020

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    Day 0, Week 1, Week 2

  • Patient Global Assessment

    Week 1, Week 2, Week 4

  • Bumps/Blemishes Count

    Day 0, Week 1, Week 2, Week 4

Study Arms (1)

Subjects with facial redness

EXPERIMENTAL

Topical application twice daily for 4 weeks

Drug: CGB-400

Interventions

CGB-400DRUG

BID application

Subjects with facial redness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.
  • Facial redness (IGA-R) 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 DiseasesSkin 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 7, 2020

First Posted

August 11, 2020

Study Start

October 26, 2018

Primary Completion

April 18, 2019

Study Completion

April 18, 2019

Last Updated

August 11, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(3)