Bioequivalence
Conditions
Brief summary
randomized, double-blind, placebo controlled
Detailed description
Subjects in this randomized, double-blind, placebo controlled study will be randomly assigned to treatment sequences with the test product, reference product or placebo control.
Interventions
DRUGOxymetazoline hydrochloride Cream, 1%
Cream
DRUGRhofade™ (oxymetazoline) cream, 1%
cream
DRUGPlacebo
cream
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Healthy male or non-pregnant female aged ≥18 years with a clinical diagnosis of facial rosacea; 2. Provided IRB approved written informed consent; 3. A CEA score of ≥3 prior to study drug application 4. A PSA score of ≥3 prior to study drug application
Exclusion criteria
1. Female subjects who were pregnant, nursing, or had planned to become pregnant during study participation; 2. History of hypersensitivity to the study product; 3. Presence of ≥3 facial inflammatory lesions of rosacea; 4. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, and isolated pustulosis of the chin); 5. Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression; 6. Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that could interfere with diagnosis or study assessments; 7. Presence of significant hypertension or circulatory disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| erythema response success | 21 day | at least a 2-grade improvement in both CEA and PSA |
Countries
United States
Outcome results
None listed