This is a multicenter, randomized, double-blind, vehicle-controlled, parallel design study evaluating the efficacy and safety of CGB-400 Topical Gel for the treatment of inflammatory lesions of rosacea. The study consists of a 12-week double-blind treatment period with clinic visits at Baseline (Day 0), and Weeks 2, 4, 8, and 12. Approximately 80 subjects will be enrolled and randomized at a 1:1 ratio to treatment with either CGB-400 Topical Gel (40%) BID or Vehicle Gel BID.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
78
Topical gel
Topical gel
Cage Bio Investigative Site 1
Fremont, California, United States
Inflammatory Lesion Count
Numerical count of inflammatory lesions (pustules and papules)
Time frame: Week 12
Investigator Global Assessment (IGA)
* 0 - Clear; No inflammatory lesions present; at most mild erythema * 1 - Almost clear; Very mild erythema present. Very few small papules/pustules * 2 - Mild; Mild erythema. Several small papules/pustules * 3 - Moderate; Moderate erythema. Several small or large papules/pustules * 4 - Severe; Severe erythema. Numerous small and/or large papules/pustules
Time frame: Week 12
Inflammatory Lesion Count
Numerical count of inflammatory lesions (pustules and papules)
Time frame: Weeks 2, 4, and 8
Investigator Global Assessment (IGA)
* 0 - Clear; No inflammatory lesions present; at most mild erythema * 1 - Almost clear; Very mild erythema present. Very few small papules/pustules * 2 - Mild; Mild erythema. Several small papules/pustules * 3 - Moderate; Moderate erythema. Several small or large papules/pustules * 4 - Severe; Severe erythema. Numerous small and/or large papules/pustules
Time frame: Weeks 2, 4, and 8
Rosacea Quality of Life (RosaQoL) Questionnaire
Patient Reported Outcome
Time frame: Week 12
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