Erythema
Conditions
Brief summary
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
Interventions
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite success on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment) | Day 29 | 2-grade improvement on both CEA and PSA at Hours 3, and 6 after Pre-dose (T0)on Day 29 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite improvement on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment) | Day 1 | 1-grade improvement on both CEA and PSA at 30 minutes after pre-dose (T0) on Day 1 |
Outcome results
None listed