Open-label multicenter study using CGB-400 Gel to reduce facial redness, bumps, and blemishes.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
BID application
Cage Bio Investigative Site 1
Fremont, California, United States
Cage Bio Investigative Site 2
San Diego, California, United States
Cage Bio Investigative Site 3
Edgewater, Florida, United States
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)
Time frame: 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)
Time frame: Week 12
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)
Time frame: Day 0, Week 2, Week 4, Week 8
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)
Time frame: Day 0, Week 2, Week 4, Week 8
Bumps/Blemishes Count
Numerical count of Bumps/Blemishes
Time frame: Day 0, Week 2, Week 4, Week 8, Week 12
Patient Global Assessment
5-point scale (0: excellent effectiveness; 1: good effectiveness; 2: Effective; 3: No significant benefit and 4: No benefit at all)
Time frame: Day 0, Week 2, Week 4, Week 8, Week 12
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