At a glance
ClinicalIndex Comparison Record- ✓Healthy male or non-pregnant female ≥18 years old with clinical diagnosis of moderate facial rosacea
- ✓At least 8 but not more than 50 inflammatory facial lesions (papules/pustules) and ≤2 nodules on the face
- ✓Persistent erythema on the face with moderate (definite redness, easily recognized) to severe (marked erythema; fiery red)
- ✓Mild to moderate score for telangiectasia on the face
- ✕Pregnant, lactating, or planning to become pregnant during study
- ✕Hypersensitivity or allergy to azelaic acid, propylene glycol, or other formulation components
- ✕Oral retinoids (e.g., Accutane) within 6 months prior to baseline, or vitamin A supplements >10,000 units/day
- ✕Systemic antibiotics known to impact rosacea severity (tetracycline derivatives, erythromycin derivatives, sulfamethoxazole, trimethoprim) within 1 month prior to baseline
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-blind, Randomized, Parallel-group, Vehicle-Controlled Study to Evaluate the Safety and Clinical Equivalence of a Generic Azelaic Acid Gel, 15% and the Reference Listed Finacea® (Azelaic Acid) Gel, 15% in Patients With Moderate Facial Rosacea.
In Brief
A Phase 3 clinical trial evaluating Azelaic acid, Vehicle, and 1 other intervention for Rosacea. Completed, enrolled 1,009 participants across 30 sites.
Detailed Summary
The purpose of the study is to compare the safety and efficacy profiles of a generic Azelaic Acid Gel, 15% to the reference listed Finacea® (azelaic acid) Gel, 15% in the treatment of moderate facial rosacea.
Study Details
Timeline
Interventions
Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.