A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Azeliac Acid Gel and Active Treatments to a Placebo Control in the Treatment of Moderate Facial Rosacea.
| Registry | NCT03094403 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 1000 (Actual) |
| Sponsor | Sun Pharmaceutical Industries, Inc. (Industry) |
| Conditions | Rosacea |
| Interventions | Azelaic Acid 15% topical gel, Finacea® (azelaic acid) Gel, 15%, Placebo (Drug) |
| Dates | start 2016-07-01, primary completion 2017-03-31, completion 2017-04-01, first posted 2017-03-29, last updated 2024-04-10 |
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A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, comparing AZELAIC ACID TOPICAL GEL 15% TO FINACEA® and both active treatments to a Placebo Control in the treatment of Moderate of Facial Rosacea.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Azelaic Acid 15% topical gel | Experimental | Drug: Azelaic Acid 15% topical gel | Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face |
| Finacea® (azelaic acid) Gel, 15% | Active comparator | Drug: Finacea® (azelaic acid) Gel, 15% | Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face |
| Placebo | Placebo comparator | Drug: Placebo | Topically to the face, twice a day A thin layer of study treatment was gently massaged into the affected areas on the face |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * Healthy male or non-pregnant female ≥ 18 years-of-age with a clinical diagnosis of moderate facial rosacea; * Subjects had to have a definite clinical diagnosis of facial rosacea severity Grade 3 as per the IGE Exclusion Criteria: * Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;