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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04508660
Other study ID # CGB-400-001b
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 26, 2018
Est. completion date April 18, 2019

Study information

Verified date August 2020
Source CAGE Bio Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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).


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CGB-400
BID application

Locations

Country Name City State
United States Cage Bio Investigative Site 3 Edgewater Florida
United States Cage Bio Investigative Site 1 Fremont California
United States Cage Bio Investigative Site 2 San Diego California

Sponsors (2)

Lead Sponsor Collaborator
CAGE Bio Inc. ethica Clinical Research Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Bumps/Blemishes Count Numerical count of Bumps/Blemishes Day 0, Week 1, Week 2, Week 4
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