Rosacea
Conditions
Brief summary
To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate facial rosacea.
Detailed description
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study, comparing test and reference products and both active treatments to a placebo control in the treatment of Moderate Facial Rosacea.
Interventions
Azelaic acid foam 15%
DRUGFinacea® (Azelaic acid Foam) 15%
Azelaic acid foam 15%
Vehicle of the test product
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or non-pregnant female aged ≥ 18 with a clinical diagnosis of facial rosacea. * Subjects must have provided IRB approved written informed consent.
Exclusion criteria
* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation. * Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in the inflammatory lesion counts | 12 weeks | Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts |
Countries
United States
Outcome results
None listed