Erythema | Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Persistent Facial Erythema
Erythema research study
What is the primary objective of this study?
The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily for 29 days versus vehicle control, in subjects with moderate to severe chronic persistent vascular facial erythema
Who is eligible to participate?
Inclusion Criteria: - Male or female, who is at least 18 years of age or older at screening visit. - Presence of chronic persistent vascular facial erythema for ≥ 3 months by history. - A Clinician's Erythema Assessment (CEA) score of ≥3 at Screening and at Pre-dose (T0) on Baseline/Day 1. - A Patient Self Assessment (PSA) score of ≥3 at Screening and at Pre-dose (T0) on Baseline/Day 1. Exclusion Criteria: - More than 2 facial inflammatory lesions (papules, pustules, and nodules). - Presence of areas of significant scaling or crusting on the face. - Presence of psoriatic lesions on the face. - Presence of any other dermatological condition of the face that, in the opinion of the Investigator, may significantly interfere with the interpretation of the clinical trial results.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:CD07805/47 Gel 0.5%
Drug:CD07805/47 Gel Placebo
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
CD07805/47 Gel 0.5%active arm
CD07805/47 Gel PlaceboComparator arm
Phase: Phase 3
Primary Outcome: Composite success on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment)
Secondary Outcome: Composite improvement on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment)
Study sponsors, principal investigator, and references